Clinical, Pharmaceutical and Contract Research Resources

We offer a large database of scientific articles and papers, most of which include authors from our esteemed leadership team.

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IT’S ALL ABOUT RELATIONSHIPS: The key to improving study site performance

In this latest PharmaTimes Magazine article, Jeff Zucker explains the key to improving study site performance.

Research Challenges in Early Parkinson’s Disease: Diagnosis, Trial Design & Rater Training

Live Webinar | 20 April 2017
To commemorate Parkinson’s Awareness Month in April Worldwide experts will come together on 4/20 to address the prevalence and understanding of early and prodromal Parkinson’s Disease, including new concepts and key success factors regarding the design of clinical trials.

The Biosimilar Market: An Evolving Landscape in MS Research

On-Demand Webinar:
To commemorate MS Awareness Month in March, Worldwide experts addressed the emerging biosimilar market and the problem solving challenges it presents for designing clinical development programs for Relapsing-Remitting Multiple Sclerosis (RRMS).

Inclisiran in Patients at High Cardiovascular Risk with Elevated LDL Cholesterol

Article:
Low-density lipoprotein (LDL) cholesterol is a causal factor in atherosclerotic cardiovascular disease. Original: http://www.nejm.org/doi/full/10.1056/NEJMoa1615758

Early Phase Services Infographic

Infographic:
Learn interesting facts about Worldwide’s Early Phase Services, including details about our San Antonio, TX clinical research facility.

Bioanalytical Solutions Infographic

Infographic:
Learn interesting facts about Worldwide’s bioanalytical sciences solutions, including details about our Austin, TX bioanalytical sciences facility.

Multiple Sclerosis Expertise Kit

Learn about Worldwide’s expertise in MS clinical research.

Rare Disease Expertise Kit

Learn about Worldwide’s expertise in rare disease clinical research.

Rare Disease Research: Q&A with Dr. Murphy on the Current State of R&D Activity in Orphan Disease Trials

Article:
Rare Disease Research: Q&A with Dr. Murphy on the Current State of R&D Activity in Orphan Disease Trials

Expertise in Protein Binding

Fact Sheet:
The growing cost of drug development emphasizes the need to minimize risk during the early stages of R&D. Worldwide Clinical Trials provides a comprehensive solution to ensure consistent quality from compound optimization and preclinical stages through clinical study sample collection and analysis. Our experience executing binding studies coupled with the application of larger capacity, automated formats affords high quality, on-time data at a good value.

Expertise in Human AME Services

Fact Sheet:
Tests to determine the absorption, metabolism and excretion (AME) of a compound are among the most vital for a new chemical entity. Worldwide Clinical Trials offers comprehensive clinical and bioanalytical human AME services. As indicated in the FDA MIST Guidance, ‘the identification of differences in drug metabolism between animals used in nonclinical safety assessments and humans as early as possible in the drug development process’ is encouraged.

Expertise in Early Phase Services & Bioanalytical Sciences

Fact Sheet:
We offer a full range of Phase I-IV services as well as expert advice on everything from protocol development to regulatory submission. We are committed to highly efficient, cost-effective methods and processes, and we provide the kind of service that builds long-term relationships based on trust, teamwork and consistent performance.

Expertise in Early Phase Services

Fact Sheet:
The Worldwide Clinical Trials’ Early Phase Services moder clinical research and development site in San Antonio, Texas, houses a total of 300 beds and is GCP/ICH compliant. These facilities offer the essentials for storing and dispensing study drugs, along with maintaining regulatory documents and study data. Specimens are seamlessly transferred to our Bioanalytical Sciences division, or lab of your choice, for sample analysis.

Expertise in Clinical Laboratory

Fact Sheet:
Worldwide Clinical Trials’ Early Phase Services offers the convenience of an on-site CLIA-certified Clinical Laboratory that can provide a wide variety of high quality testing services and rapid turnaround time for results.

Expertise in Bioanalytical Services

Fact Sheet:
Since 1990, Worldwide Clinical Trials Bioanalytical Sciences has built its reputation on providing quality bioanalytical services with rapid turnaround at competitive prices. With the most modern bioanalytical instrumentation and over 2,200 validated methods, our state-of-the-art facilities and knowledgeable staff are at the forefront of bioanalytical method development.

Rare Disease Day Turns Spotlight on Research

Article:
The international 10th annual Rare Disease Day, which is coordinated by the European Organization for Rare Diseases, seeks to help the public understand how rare diseases impact people’s lives, and bring these diseases to the attention of policy makers, public authorities, industry representatives, researchers, and health professionals.

Five Emerging Trends within Cardiovascular Research

White Paper:
Five emerging trends within the drug discovery/drug development paradigm are highlighted in this review – each reinforcing the need for therapeutically focused, methodologically rigorous, and highly efficient project teams for product evaluation and commercialization.

Refining Clinical Diagnosis of Progressive Supranuclear Palsy: Implications for Disease Modification Trials

Article:
The manifold symptoms and broad phenotypic variability of PSP may in part account for its diagnostic challenges, particularly in the early stages of the disease. This review will delineate various diagnostic schema in defining PSP with an overall aim of improving diagnostic accuracy in clinical trials, resulting in decreased patient heterogeneity with accompanying improvement of signal detection in the assessment of putative therapeutic agents.

Rare Disease Clinical Trials: An Opportunity for Differentiated Services

On-Demand Webinar:
During this on-demand webinar, Worldwide experts address rare disease clinical trials and the opportunity for innovative trial design and execution.

Exploring the Future of Clinical Research for Immune-Mediated Inflammatory Diseases

White Paper:
Significant and ongoing research into IMID pathology and genetic links have led to the knowledge that underpinning these diseases is the dysregulation of the immune system, which leads to widespread and chronic inflammation. These discoveries have delivered a more comprehensive understanding of immune-mediated mechanisms, and the promise for more effective treatments and possibly even cures for a range of IMID disorders.

Cardiovascular Expertise Kit

Learn about Worldwide’s expertise in CV clinical research.

Cardiovascular Expertise Kit

To commemorate Heart Month, we have compiled a cardiovascular (CV) expertise kit to showcase our commitment to CV clinical research.

Expertise in Pharmacy Services

Fact Sheet:
Pharmacy plays a crucial role in the early drug development process, from compounding and drug preparation to the novel roles of protocol review and drug administration.

Maximizing Patient Recruitment in Rare Disease Research

Article:
This article discusses the steps that researchers can take, particularly when it comes to patient recruitment. This article was written by Jeffrey Zucker, Vice President, Feasibility and Recruitment Optimization at Worldwide Clinical Trials and Barbara Zupancic, Director of Global Patient Recruitment and Retention at Worldwide Clinical Trials.

Expertise in Cardiovascular

Fact Sheet:
A full-service CRO, Worldwide Clinical Trials delivers fully integrated clinical development and bioanalytical services for studies small to large, multisite clinical trial programs, and first-in-human through phase IV clinical research programs, for customers of all sizes.

The Rise of Registries

Article:
Identifying risk has consistently remained a top priority in clinical trials – especially in transformative therapies. With changes to study development, safety, value and innovation, the widespread utilisation of registries could mean a transformational shift across the whole trial landscape.

The Future in Heart Failure: Novel Therapies, Innovative Trial Designs & Stakeholder Diversity

On-Demand Webinar:
To commemorate Heart Month, Worldwide Clinical Trials hosted a webinar where Worldwide experts discussed emerging heart failure therapies & trial designs, demonstrating value when novelty is not enough, and stakeholder diversity.

Worldwide Clinical Trials Named “Best in Neuroscience Therapeutics” by Corporate LiveWire Healthcare & Life Sciences Awards 2016

Article:
Corporate LiveWire recognized Worldwide Clinical Trials as “Best in Neuroscience Therapeutics” in its special issue announcing the winner of its 2016 Healthcare & Life Sciences Awards, where this company profile was featured. The awards celebrate the most innovative and successful projects carried out around the world over the previous 12 months.

Sex Differences in the Psychopharmacological Treatment of Depression

Article:
This article reviews the history and current research on sex effects of antidepressant treatments. It is published by John J. Sramek, PharmD; Michael F. Murphy, MD, PhD; and Neal R. Cutler, MD, in Dialogues in Clinical Neuroscience. Copyright Association La Conférence Hippocrate – Servier Research Group. Journal link: www.dialogues-cns.org

Managing Benefits and Risks of Opioids in Paediatric Populations: A Review of FDA Paediatric Advisory Committee on Opioid Studies

Article:
The FDA recently conveyed a meeting to discuss opioid use in the paediatric populations with the purpose of ensuring a balance between the exuberance to control the spread of opioid use disorders whilst a guaranteeing that patients continue to have access to the appropriate treatments for their pain and, importantly, to address ways to incorporate paediatric populations into future clinical studies of opioids. This article was published in the International Pharmaceutical Industry Journal.

Why We Need to Redefine The “Team” in Rare Disease Trials

Article:
Dr. David Frakes M.D., senior vice president of Project Management for Neuroscience at Worldwide Clinical Trials, discusses why we need to redefine the “team” in rare disease trials.

The Unique Challenges of Cardiovascular Outcome Studies

On-Demand Webinar:
During this free on-demand webinar, Worldwide Clinical Trial experts address the common challenges and key success factors of cardiovascular outcomes trials.

Hypothesis Generation: An Essential Component of Informed Healthcare Management

Article:
In this article, Michael F. Murphy, Chief Medical and Scientific Officer at Worldwide Clinical Trials, concludes that although the applicability of the TCoC estimator in population healthcare management and in program development is intuitive, applications are apparent for other stakeholders given its accessibility and variety of model inputs, accentuating the importance of hypothesis generation as well as testing for therapeutic optimization on a population level.

Patient Characteristics, Adherence, and a Metric of Organizational Performance in Behavioral Health

Article:
Michael F. Murphy, Chief Medical and Scientific Officer at Worldwide Clinical Trials, states that factors related to medication adherence and cost suggest that antipsychotic medication use can improve outcomes in selected patients.

21st Century Cures Act Holds Promise for Patients

Article:
The 21st Century Cure Act promises to promote the development and hasten the approval of new drugs and devices, especially treatments for cancer and rare diseases. Michael Murphy, Chief Medical and Scientific Officer at Worldwide Clinical Trials, discusses the opportunities within patient-focused drug development and disease-related biomarkers.

The Changing Clinical Landscape

Article:
As clinical operations and development have become increasingly complex—from protocols to new science—sponsors, CROs, and sites need to manage a multitude of variables to meet the growing demand for new treatments. Michael Murphy, Chief Medical and Scientific Officer at Worldwide Clinical Trials, states that “the opportunity lies with a participatory approach that leverages the patient perspective in the research experience to inform protocol design and the burden of proposed assessments.”

Going All In on eCOA

Article:
Significant growth opportunities in the eCOA field mean the industry is calling out for solutions, advice and guidance that can help deliver on its promises.

Key Considerations for ‘Siteless’ Clinical Trials

Article:
Advancements in technology are impacting many aspects of clinical research, opening doors to innovative study designs and clinical operations that may not have been possible even five years ago.

The Impetus for Observational Research in Orphan Drug Development

On-Demand Webinar:
During this free on-demand webinar, Worldwide Clinical Trial experts discuss emerging trends in clinical trial methodology for orphan disease drug development and ways to overcome challenges through the use of observational trials.

Cardiovascular Outcome Trials Case Study

Case Study:
Worldwide Clinical Trials offers well-established drug and clinical supply depots, state-of-the-art refrigeration facilities, and/or distribution services across Russia, Ukraine, Georgia, Belarus and Armenia.

Patient Recruitment and Retention Case Study

Case Study:
Worldwide Clinical Trials offers well-established drug and clinical supply depots, state-of-the-art refrigeration facilities, and/or distribution services across Russia, Ukraine, Georgia, Belarus and Armenia.

Global Patient Recruitment Case Study

Case Study:
Worldwide Clinical Trials offers well-established drug and clinical supply depots, state-of-the-art refrigeration facilities, and/or distribution services across Russia, Ukraine, Georgia, Belarus and Armenia.

Expertise in Efficient Drug & Clinical Supply Management

Fact Sheet:
Worldwide Clinical Trials offers well-established drug and clinical supply depots, state-of-the-art refrigeration facilities, and/or distribution services across Russia, Ukraine, Georgia, Belarus and Armenia.

Expertise in Improving Site Relationships

Fact Sheet:
Learn more about how to build site relationships to maximize productivity using modern techonological approaches that complement more traditional approaches that have been long-established for clinical research site communication.

Expertise in Successful Patient Recruitment & Retention

Fact Sheet:
Learn more about how to keep enrollment targets on track with strategic, proactive patient recruitment methods.

Expertise in Analgesia & Pain

Fact Sheet:
Worldwide has extensive capabilities in global analgesia research, including experience with human experimental and clinical models for proof-of-concept in nociceptive and neuropathic pain and for registration studies to support marketing authorization in a number of acute and chronic pain indications.

Expertise in Alzheimer’s Disease

Fact Sheet:
Our tradition of excellence is centered on Alzheimer’s Disease, with our unparalleled experience in this indication (including related dementias) allowing us not only to understand the complexities associated with evaluating patients with various phenotypes, but also to implement specific design features through the use of strategies to mitigate the risks and challenges in the Alzheimer’s field.

Alzheimer’s Disease Clinical Trials: Improving Screen Failure and Recruitment Rates

On-Demand Webinar:
View this on-demand webinar to hear Worldwide Clinical Trial experts discuss historical reasons for screen failure rates in Alzheimer’s disease, predictable vs unpredictable causes of screen failure, and the challenges of Alzheimer’s disease patient recruitment.

Neurology Case Study: Problem Solving for Uninterrupted Trial Progress

Case Study:
Worldwide Clinical Trials was retained to intervene in a Phase IIb, multinational, randomized, double-blind, placebocontrolled study, in subjects with progressive cognitive decline compatible with the diagnosis of prodromal AD.

Respiratory Case Study: Idiopathic Pulmonary Fibrosis

Case Study:
Worldwide Clinical Trials has conducted three studies in Idiopathic Pulmonary Fibrosis (IPF), including Phase II, phase III, and open label extension studies.

Optimizing the Assessment of CNS Side Effects of a Novel Neuropathic Pain Compound

Poster:
The current study explored standardized psychometric tests to determine their ability to efficiently and sensitively detect common CNS side effects (dizziness, somnolence, sedation, and difficulties in concentration/attention) of a potent and specific novel neuropathic pain compound.

Use of Naltrexone to Block Opioid Side Effects in Healthy Volunteers: Effects of Dose and Food

Poster:
A retrospective review of common adverse events (AEs) associated with morphine (headache, nausea, vomiting and sedation) was conducted across a series of inpatient bioequivalence (BE) studies that compared generic versions of morphine extended release with brand morphine extended release (Avinza®).

Rapid Development of Tolerance to Adverse Events After Oral Morphine Administration to Opiate Naïve Subjects

Poster:
Tolerance to opiate adverse events (AEs) has been observed to occur with repeated dosing, but the time course of its development is not well understood. We sought to determine whether tolerance would develop to the initial, unpleasant effects of morphine after repeated exposure in opiate-naïve subjects.

Expertise in Immune-Mediated Inflammatory Disorder Clinical Trials

Fact Sheet:
A valuable CRO offers experiential wisdom along with forward thinking and flexibility. When medicine advances and long-held concepts evolve, you want to be working with specialists who are versed in the new approaches and already meeting fresh, related challenges.

Accelerating Analgesics Development

On-Demand Webinar:
This on-demand webinar highlights several Early Human Experimental Models of Pain (HEMP) models, application techniques and associated outcome measures, and the potential of these models to significantly accelerate analgesic drug and interventions development.

Improving Screen Failure and Recruitment Rates in Alzheimer’s Disease Clinical Trials

Article:
The failures of clinical trials in Alzheimer’s Disease (AD) have been attributed to a variety of factors, including an inadequate understanding of mechanisms of action and/or poor target engagement; however, other factors such as inadequate study design, wrong clinical stage of AD matched to the drug’s mechanism of action, limited statistical power of endpoint measures, and inclusion of participants who may otherwise not be eligible for the trial, have all contributed to the poor success rate of AD trials.
This article is taken from the Journal for Clinical Studies, Volume 8, Issue 5, Pg 40 and is authored by Henry J. Riordan, Ph.D.

Improving Development of Antiepileptic Drugs for Rare Forms of Epilepsy

Article:
Therapeutic development in rare diseases involves many challenges such as an incomplete understanding of the disease to inform trial design, requirements for new or more sensitive and specific outcome measures, and difficulties of recruiting a small sample to participation, among others.
This article is taken from the Journal for Clinical Studies, Volume 8, Issue 3, Pg 34 and is authored by Idil Çavuş, M.D. PhD.

Electronic Data Acquisition: Q&A with Dr. Michael Murphy

Article:
Dr. Michael Murphy at Worldwide Clinical Trials tackles the big questions on the minds of drug development and clinical research professionals, and explores the impact of technology on today’s studies.
This article is taken from International Clinical Trials August 2016, by Dr. Michael F. Murphy, pages 51-54. © Samedan Ltd.

Improving Clinical Site Performance

On-Demand Webinar
In this webinar, we share tips on how sponsors, CROs & trial sites can best work together to impact study execution & success. The webinar is hosted by Jeff Zucker, Worldwide’s VP of Feasibility and Recruitment Optimization. Jeff is joined by guest speaker Woody Woodman, President & CEO of Synergy Clinical Research Centers.

Are We Moving Toward ‘Siteless’ Clinical Trials?

On Demand Webinar
In a conversation led by Dr. Michael Murphy, M.D., Ph.D., Worldwide’s Chief Medical & Scientific Officer, Worldwide experts discuss the current state and future potential for home-based studies.

Expertise in Neurology Clinical Trials

Fact Sheet:
Worldwide has participated in the design, execution, or analysis of 105 trials, over 550 sites and 2840 patients since 2008. Of the 105 total trials, 55 studies have included at least clinical monitoring or project management. A majority of these studies have been conducted globally including unique capabilities in Russia, Ukraine and Eastern Europe.

Expertise in Neuroscience Clinical Trials

Fact Sheet:
A valuable CRO offers experiential insight along with forward thinking and flexibility. When medicine advances and long-held concepts evolve, you want to be working with specialists who are versed in the new approaches and already meeting fresh, related challenges. Those specialists are at Worldwide.

Challenges of Clinical Research in Parkinson’s Disease

On Demand Webinar
In this webinar, Tom Babic, M.D., Ph.D., vice president of Neuroscience for Worldwide, discusses the unique challenges of clinical research in Parkinson’s disease and the opportunities that exist to optimize clinical trial outcomes.

Asthma Infographic

Infographic:
Learn more about the lives lost, cost and promise of clinical studies for Asthma.

Clinical Trials Infographic

Infographic:
View this infographic to learn more about the hundreds of thousands of clinical studies taking place each year.

Strategic Regulatory and Operational Challenges of Rare Disease Studies

On Demand Webinar
In a discussion led by Dr. Michael Murphy, Worldwide’s Chief Medical & Scientific Officer, this webinar features experts who provide insight into the strategic regulatory and operational challenges of rare disease drug trials.

Expertise in Respiratory Clinical Trials

Fact Sheet:
At Worldwide Clinical Trials, our experts understand that the commercial viability of therapeutics for chronic respiratory disorders is influenced by a range of factors, including perceived value and therapeutic novelty.

A Review of FDA’s Action Plan to Proactively Reduce Prescription Opioid Abuse

Article:
The increasing rates of opioid abuse and dependence, and the alarming rise in the number of prescription opioid-related overdoses and deaths in the US has caused government agencies around the globe to launch various initiatives in an attempt to stem the tide of this devastating public health crisis.
This article is taken from the Journal for Clinical Studies, April 15, 2016, by Henry J. Riordan, Ph.D.

Evolving Landscapes in Multiple Sclerosis Research: Adaptive Designs and Novel Endpoints

Article:
The increasing amount of highly effective treatment options in relapsing forms of multiple sclerosis (MS) requires innovative clinical trial design strategies. These strategies may encompass the application of adaptive designs as well as the adoption of innovative primary outcome measurements.
This article is taken from Multiple Sclerosis and Demeyelinating Disorders, April 1, 2016, by Manolo E. Beelke, Paola Antonini and Dr. Michael F. Murphy.

Worldwide Clinical Trials Practical Expertise in Clinical Neuroscience Research

Poster:
Learn about our staff and expertise in neuroscience disorders.

Parkinson’s Infographic

Infographic:
Explore facts about the global impact of Parkinson’s disease.

Parkinson’s Awareness Slide Share

Slide Share:
Hear from those living with Parkinson’s disease, including well-known public figures.

Alzheimer’s Expertise Kit

Learn more about Alzheimer’s Disease and research being done by downloading our Alzheimer’s Awareness Kit.

Sticking with Tradition: Clinical Trial Sites Prefer Paper Records

Article:
According to a recent survey, the majority of clinical trial site staff prefers paper-based assessments over eCOA solutions.
This article is taken from Outsourcing-pharma, March 9, 2016, by Melissa Fassbender.

Alzheimer’s Awareness

Learn about the global impact of Alzheimer’s disease and discover ways you can join the fight to find a cure.

Should Risk-Based Monitoring be Considered in Every Program?

Our experts debate the pros/cons of Risked-Based Monitoring.

Clinical Trials Video

In this video, we review the vital role played by clinical trials in the complex process of bringing a new drug to market.

About Worldwide Clinical Trials

Worldwide Clinical Trials focuses on Neuroscience, Cardiovascular Disease, Immune-Mediated Inflammatory Disorders, and Rare Disease.

Neuroscience Infographic

Infographic:
“The Amazing Brain” — view our infographic for more information on the global impact of brain disorders.

Unified Approaches to Rare Disease Research

Article:
Rare Disease Day aims to increase awareness of rare diseases and their impact on patients, families, and medical professionals. Hundreds of organizations are helping doctors find diagnoses and sufferers find solace.
This article is taken from Clinical Informatics News, March 8, 2016, by Maxine Bookbinder.

Alzheimer Infographic

Infographic:
“Finding a cure for Alzheimer’s disease – We’re up to the Challenge.” We explore the staggering statistics of this devastating disease in this infographic.

Cardiovascular Disease Infographic

Infographic:
We get to the “Heart of the Matter” of the global impact of cardiovascular disease in this infographic.

Rare Disease Infographic

Infographic:
We take a look at the challenges and promise of the study of rare and orphan diseases in this infographic, “Giving a Voice to Rare Disease.”

Promises to Keep: Informing Healthcare Decisions through Cardiovascular Outcomes Studies

Article:
Despite the global burden of cardiovascular disease, investment in cardiovascular drug development has stagnated over the past two decades, which is a relative underinvestment compared to other therapeutic areas.
This article is taken from PharmaVoice, February 2016, by Dr. Michael F. Murphy, MD, PhD and Paola Antonini, MD, PhD.

Updated Diagnostic Criteria for Parkinson’s Disease: Implications for Clinical Trials

Article:
To update the criteria to diagnose Idiopathic Parkinson’s Disease’s (IPD), the Movement Disorders Society (MDS) has recently published Clinical Diagnostic Criteria for Parkinson’s disease (MDS-PD), designed specifically for use in clinical research, but also as a general guide to clinical diagnosis of IPD consequent to Lewy body pathology.
This article is taken from the Journal for Clinical Studies, February 24, 2016 by Tomislav Babic, MD, PhD.

Rare Diseases: Meeting the Unique Challenges of Orphan Drug Development

Article:
While individually rare, orphan diseases are actually collectively common, with an estimated 350 million sufferers worldwide. Creating a pharmaceutical development program for the treatment of a rare disease can, however, prove to be a monumental task.
This article is taken from Applied Clinical Trials, January 21, 2016, by Dr. Michael F. Murphy, MD, PhD.

Burn Trauma: An Emerging Model for Acute Pain

Article:
Emphasis in acute pain studies has shifted to outcomes that go beyond “good pain relief” to reductions in the risk of developing chronic pain, acute medical conditions, and the development of psychological disturbances due to pain.
This article is taken from the Journal for Clinical Studies, December 2015, by Jayne Abraham, PhD.

Optimizing the Design of Dementia with Lewy Bodies Trials

Article:
Dementia with Lewy bodies (DLB) is a neurodegenerative disorder characterised by parkinsonism and cognitive impairment but may also manifest multiple symptoms of dysautonomia, rapid eye movement (REM) sleep behavior disorders, hallucinations, and cognitive fluctuations.
This article is taken from the Journal for Clinical Studies, April 15, 2016, by Tomislav Babic, MD, PhD and Henry J. Riordan, PhD.

Key Design Considerations On Comparative Clinical Efficacy Studies For Biosimilars: Adalimumab as an Example

Article:
The global development of a biosimilar product is a methodologically complex affair, lined with potential design pitfalls and operational missteps to be avoided. Without careful attention to experimental design and meticulous execution, a development programme may fail to demonstrate equivalence, and not receive regulatory approval based on current guidance.
This article is taken from RMD Open, December 19, 2015, by Zhihong Lai and Anna La Noce.

Exploratory Biomarker Study of the Triple Reuptake Inhibitor SEP-432 Compared to the Dual Reuptake Inhibitor Duloxetine in Healthy Normal Subjects

Article:
SEP-432 is a triple monoamine reuptake inhibitor of norepinephrine (NE), serotonin (5-HT), and dopamine (DA), based on in vitro binding studies. Leaders sought evidence that SEP-432 engages these monoamine systems by measuring concentrations of monoamines and/or their main metabolites in cerebrospinal fluid (CSF) and plasma and comparing results to duloxetine, a dual reuptake inhibitor of NE and 5-HT.
This article is taken from CNS Neuroscience & Therapeutics, December 11, 2015, by John J. Sramek, Larry W. Hardy, Peter Bieck, Cynthia Zamora, Mark Versavel, Jahnavi Kharidia, Todd Grinnell, Yu-Luan Chen, Michael Sullivan, Hong Ding & Neal R. Cutler.

The 21st Century Cures Act

Article:
Thought leaders respond to the relevant ways the 21st Century Cures Act is going to impact the industry.
This article is taken from PharmaVoice, November/December 2015, by Matt Gross, Mike Hodgson, Ken Horne, Michael Murphy, MD, PhD.

Understanding Site Preferences With eCOA Technologies Used to Increase the Reliability of Clinical Assessments: A Multi-National Survey

Poster:
The goal of this investigation is to better understand site perceptions regarding these technologies in an effort to address potential shortcomings, leading to their greater usage that will enhance the overall quality of rater assessments.
This poster is written by Douglas Lytle, Ph.D., MBA, Elan A. Cohen, Ph.D., Colleen R. Rock, BA, Andrew E. Komorowsky, MS, Bethanne Friedmann, Psy.D., Michael Murphy, M.D., PhD

Examining the Impact of Ongoing Assessment Feedback on Site Rater Performance: Does Our Work Matter?

Poster:
Rater training companies provide ongoing data surveillance to ensure appropriate scale administration, scoring, and protocol parameters are maintained. However, do site raters improve with ongoing surveillance?
This poster is written by Kim F. Baldwin, MA, MFT, Rolana Avrumson, MS, Elan A. Cohen, Ph.D., Bethanne Friedmann, Psy.D., ,Melissa A. Carbo, MS, Natalie C. Glaug, BA, Andrew E. Komorowsky, MS,Eleni Rapsomaniki, PhD, Colleen R. Rock, BA, Michael F. Murphy, MD., PhD.

Pharmacy Services in a Phase I Clinical Research Unit

White Paper:
Phase I clinical studies form an important foundation for drug development and eventual approval of life-saving therapies in man. Potential drug candidates are screened for entry into Phase I trials by extensive in-vitro testing and tolerance in several animal species. Published in Dialogues in Clinical Neuroscience; copyright Association La Conférence Hippocrate – Servier Research Group.

Expertise in Psychiatry Clinical Trials

Fact Sheet:
Our team’s experience in Central Nervous System clinical research is unsurpassed. Our leadership team has published more than 400 articles in peer reviewed journals and authored more than nine textbooks in the field of CNS pharmaceutical research, including a release on optimizing critical pathways in CNS drug development.

A Teachable Moment in Health Benefits Design

Article:
In their article, Carlton and colleagues evaluate the expected costs and budget impact of interventional, short-term therapy for chronic venous disease from a third-party US payer perspective. Their budget impact model transcends the immediate clinical and budgetary implications for the treatment of varicose veins and provides a “teachable moment” for a process that is foundational to informed health benefits design.
This article is taken from American Health & Drug Benefits, August 9, 2015, by Dr. Michael F. Murphy, MD, PhD.

Assuring Patient Adoption during Biosimilar Development and Commercialization

White Paper:
Successful clinical development and commercialization of small molecules and biologics require that investigators, sponsors, and patients collaborate to preemptively facilitate study design, execution, and transition to commercialization.

Evolution of Value for Oncology Therapies

Article:
The healthcare environment is a mosaic of stakeholders, each with remarkably different demands for data addressing product attributes. These often conflicting perspectives require access to a portfolio of interventional and observational research designs to effectively demonstrate the value of a novel oncology therapy in development.
This article is taken from Applied Clinical Trials, September 8, 2015, by Thomas F. Gross, Nicole Sweeney, and Dr. Michael F. Murphy, MD, PhD.

Minimising Placebo Response in Chronic Pain Trials

Article:
This brief review elucidates some of the factors that contribute to the heightened placebo response in trials of drugs for common chronic pain indications such as osteoarthritic pain, low back pain and neuropathic and highlights easily implemented maneuvers to remedy this problem.
This article is taken from the Journal for Clinical Studies,October 6, 2015, by Henry J. Riordan, PhD.

Expertise in Multiple Sclerosis Clinical Trials

Fact Sheet:
Worldwide Clinical Trials tackles the clinical development of novel MS therapies and its inherent unpredictability with extensive operational experience and unrivaled therapeutic insight.

Optimising MRI in Multiple Sclerosis Drug Development

Article:
This review will summarize important design issues in proof of concept studies of RRMS with an emphasis on optimizing neuroimaging outcome measures designed to help speed clinical development of novel drugs and biologics.
This article is taken from the Journal for Clinical Studies, August 20, 2015, by Tomislav Babic, MD, PhD and Henry J. Riordan, PhD.

Expertise in Rare Disease Clinical Trials

Fact Sheet:
Building a pharmaceutical development program for the treatment of a rare disease is a monumental task. You know the challenges: poor understanding of the natural history due to few investigators studying the disease, heterogeneous patient populations with variable phenotypes and clinical courses, geographic dispersion of patients and investigators, regulatory uncertainties, and lack of prior clinical studies to establish a template for study execution.

Methodological Issues in Design and Conduct of Opioid Use Disorders Studies

Article:
There are several unique methodological challenges in the design and conduct of studies assessing the efficacy of various opioid use disorder treatments. Nonetheless, with careful planning these can all be effectively managed.
This article is taken from the Journal for Clinical Studies, June 15, 2015, by Barry J. Dussault, Jr., MBA, Henry J. Riordan, PhD.

Demonstrating Value for Biosimilars: A Conceptual Framework

Article:
The objectives of this paper are to identify factors that facilitate and inhibit the development, commercialization, and adoption of biosimilars, and to recommend modifications in program design that are likely to support the demonstration of the value of biosimilars for payers, providers, and patients.
This article is taken from American Health & Drug Benefits, May 2015, by Sotiris Rompas, PhD; Thomas Goss, PharmD; Sally Amanuel, BSc, MA, MBA; Victoria Coutinho, BSc, PhD; Zhihong Lai, PhD; Paola Antonini, MD, PhD; Michael F. Murphy, MD, PhD.

Cystic Fibrosis

Case Study:
Worldwide Clinical Trials has conducted a case study in Pediatric Patients, including Phase II, with new-onset pseudomons aeruginosa infection.

Patchwork Regulatory Guidance for Biosimilars: Impact on Biosimilar Development

White Paper:
The European Medicines Agency released the first guidance for biosimilar production in 2005. It facilitated the initial wave of registrations for human growth hormone, epoetin, and filgrastim biosimilars.

The Role of Observational Research and Patient Registries in Evidence Generation

White Paper:
The modern healthcare environment is a mosaic of stakeholders, each with remarkably different demands for data addressing product attributes. These often conflicting perspectives require access to a portfolio of interventional and observational research designs subserving different objectives, and tiered in important and timing during the drug development cycle.

Expertise in Oncology Clinical Trials

Fact Sheet:
Recent understandings have both enlightened and complicated oncology clinical research. Key among them is the heterogeneity of tumors at the same primary site.

CSF Biomarkers of Disease Modification in Alzheimer’s Disease

Article:
Although several CSF biomarkers have shown some degree of utility in diagnostic accuracy as biomarkers in predicting conversion to AD from mild cognitive impairment (MCI), and as a tool to enrich patients for clinical trials to increase statistical power, these biomarkers have not shown similar success in evaluating the effectiveness of therapeutic interventions in AD.
This article is taken from the Journal for Clinical Studies, May 14, 2015, by Henry J. Riordan, PhD, and Neal R. Cutler, MD.

Overcoming Regulatory Challenges in Cognitive Drug Development

Article:
This paper describe some of the more salient regulatory challenges involved in determining the appropriateness and legitimacy of a possible target involving cognitive impairment associated with various CNS – (central nervous system) disorders and how to overcome these challenges.
This article is taken from the Journal for Clinical Studies, February 9, 2015, by Henry J. Riordan, PhD.

CSF and Plasma Monoamine Profile of the Triple-Reuptake Inhibitor SEP-432 in Healthy Volunteers

Poster:
Based on in-vitro binding studies, SEP-432 is a triple monoamine reuptake inhibitor with a binding affinity for NE>5HT>DA. We determined the maximal tolerated dose (MTD) of SEP-432 to be 300mg/day, and in this study characterized its monoamine profile compared with duloxetine and placebo.
This poster is written by John Sramek PharmD, Peter Bieck M.D Ph.D, Cynthia Zamora M.D, Larry W Hardy Ph.D, Todd Grinnell Ph.D, Mark Versavel M.D,Jahnavi Kharidia Ph.D, Michael Sullivan M.S, Henry Riordan Ph.D and Neal R Cutler M.D.

CSF biomarker variability in the Alzheimer’s Association quality control program

Article:
The cerebrospinal fluid (CSF) biomarkers amyloid beta 1–42, total tau, and phosphorylated tau are used increasingly for Alzheimer’s disease (AD) research and patient management. However, there are large variations in biomarker measurements among and within laboratories.
This article is taken from Alzheimer’s & Dementia, The Journal of the Alzheimer’s Association by Niklas Mattssona, Ulf Andreasson, Staffan Persson, Maria C. Carrillo, Steven Collins, Sonia Chalbot, Neal Cutler, Diane Dufour-Rainfray, Anne M. Fagan, Niels H. H. Heegaard, Ging-Yuek Robin Hsiung, Bradley Hyman, Khalid Iqbal, et. al.

Chronic Respiratory Diseases and Risk Factors in 12 Regions of the Russian Federation

Article:
Estimation suggests that at least 4 million people die, annually, as a result of chronic respiratory disease (CRD). The Global Alliance against Chronic Respiratory Diseases (GARD) was formed following a mandate from the World Health Assembly to address this serious and growing health problem.
This article is taken from the International Journal of COPD, by Alexander G. Chuchalin, Nikolai Khaltaev, Nikolay .S Antonov, Dmitry .V Galkin, Leonid G. Manakov, Paola Antonini, Michael Murphy, Alexander .G Solodovnikov, Jean Bousquet, Marcelo H.S. Pereira, Irina V. Demko.

The Death of CNS Drug Development: Overstatement or Omen?

Article:
CNS drugs often start off in a relatively poorer position than drugs in other indications, not just because they are viewed as a having a relatively higher risk and lower priority, but also because CNS drug developers are not routinely taking advantage of the regulatory tools available to them, such as Priority Review and Fast Track designation.
This article is taken from the Journal for Clinical Studies, by Henry J. Riordan, PhD and Neal R. Cutler, MD.

Updated Diagnostic Criteria for Alzheimer’s Disease: Implications for Clinical Trials

Article:
This CNS watch will review new criteria, the role of biomarkers in the various stages of AD, the importance of early detection in emerging markets characterized by a predominance of undiagnosed cases, and the impact of these new criteria on drug development in terms of trial design, conduct, and subject selection in AD trials.
This article is taken from the Journal for Clinical Studies, by Henry J. Riordan PhD, and Erin B. Kornsey.

Dose-Proportionality, Relative Bioavailability, and Effects of Food on Bioavailability of an Immediate-Release Oxycodone HCl Tablet Designed to Discourage Tampering

Poster:
The objective was to determine the dose proportionality of oxycodone in IRO-A tablets under fasted conditions. Secondary objectives were to assess the possible effects of food on the pharmacokinetics (PK) of oxycodone in IRO-A tablets.
This poster is written by Almasa Bass, Kenneth Sommerville, Robert Rolleri, Glenn Pixton, Jeffrey Stark, Cynthia Zamora, and Mark Leibowitz.

Evaluation of Beta Amyloid Loss to CSF Sample Collection and Storage Containers

Poster:
The accurate quantification of CSF biomarkers is paramount in the development of AD drugs but measurement has varied due to handling and storage material characteristics. The purpose of this study was to systematically evaluate an assortment of CSF collection/storage materials in hopes of identifying those associated with the least amount of CSF beta amyloid (Aβ) loss.
This poster is written by Henry J. Riordan, Ph.D, Yoka Thomas, Neal R. Cutler, M.D, Mark Leibowitz, M.D, Kathryn Rogers, Kathryn Dawson, Ph.D., Michele Malone, Steve Unger, Ph.D, and William Nowatzke Ph.D.

Determination of Ritonavir, Saquinavir and Lopinavir in Dried Blood Spots by LC/MS/MS Comparing Different Automated Extraction Approaches

Poster:
As detection sensitivity has improved substantially in recent years, collecting dried blood spots has been reconsidered for broader application instead of collecting plasma or serum. As we began to explore the utility of dried matrix spot analysis for Discovery PK applications, a decision was made to also explore other potential approaches for automating the processing of such samples.
This poster is written by Thomas Lloyd, Ravi Orugunty, Adan Orta, Andrea Butz, and Steven Hoehne.

FDA’s New Risk Evaluation and Mitigation Strategy for Opioids

Article:
The current class-wide Risk Evaluation and Mitigation Strategy (REMS) constitutes the most far-reaching REMS to date with implications for practitioners, hospital staff, pharmacists, patients and analgesia drug developers. This article is taken from the Journal for Clinical Studies, by Henry J. Riordan, PhD.

Determination of the Serotonin Metabolite, 5-Hydroxyindoleacetic Acid (5-HIAA), in Human Cerebrospinal Fluid (CSF), Plasma, and Urine

Poster:
Monitoring for serotonin in biological fluids can be a useful biomarker for a wide variety of applications. However, it can be difficult to measure the low concentrations of serotonin in human CSF and plasma. Presented here are the validation results for three methods measuring 5-HIAA in human CSF, plasma, and urine.
This poster is written by Michael P. Sullivan, Heather Rush, Anna K. Miller, and Gregory Frayne.

LC-MS/MS Method for Determination of Total Active Gentamicin in Brown Norway Rat Lung Tissue

Poster:
Genatmincin has four active components and belongs to a larger family of aminoglycoside antibiotics which are highly polar and water soluble. When delivered to the lung, the measurement of lung concentrations provides assurance that drug accumulation is limited but sufficient to overcome pulmonary infections.
This poster is written by Xiaodong Zhu, M. Tan, A. Ljungqvist, G. Poch, M. Sullivan, O. Espinosa, R. Orugunty, E. Wells, and S. Unger.

Complying with FDA Guidance on the Prospective Assessment of Suicidality in Clinical Trials

Article:
The purpose of this CNS Watch is to outline the essential elements involved in prospective suicide assessment in trials of drugs with central nervous system (CNS) effects.
This article is taken from the Journal for Clinical Studies, by Henry J Riordan, PhD.

The Role of Amyloid Biomarkers in Accelerating Alzheimer’s Disease Drug Development

Article:
This CNS watch will summarize opinions, as well as the utility of amyloid targeting drugs and biomarkers in AD drug development, including the possible use of amyloid-based surrogate biomarkers as primary efficacy variables to accelerate AD drug development.
This article is taken from the Journal for Clinical Studies, by Henry J. Riordan, PhD.

The Impact of Site Characteristics on Efficacy Measures

Poster:
The success of psychiatric trials hinges on the quality of data collected by sites. Data errors and discrepancies between the key efficacy measures of a double-blind, randomized, placebo-controlled, multicenter, phase II clinical trial designed for adult attention deficit/hyperactivity disorder (ADHD), were closely monitored by a panel of clinical experts.
This poster is written by Bethanne Friedmann, PsyD, Erin B. Kornsey, M.S, Kathryn Dawson, Ph.D, Henry J. Riordan, Ph.D, Michael F. Murphy, M.D, Ph.D,and Neal R. Cutler, M.D.

Postapproval Development Options in COPD: A Case Study in Value-Based Healthcare Systems

Article:
The introduction of novel therapeutics into an era of globaization mandates research programs that are relevant to the registration process, payers and purchasers, transparent pricing, and rule-driven business practices, while providing data relevant to marketing initiatives internationally.
This article is taken from American Health and Drug Benefits, by Dr. Michael F. Murphy, MD, PhD; Paola Antonini, MD, PhD; Zhihong Vicki Lai, PhD.

The Impact of Decreased Bead Count to Determine MFI Values for Total-tau, Amyloid Beta, and Phospho-tau181 in Human Cerebrospinal Fluid by Flow Based Fluorometric Immunoassay

Poster:
Objectives of this poster are to summarize accuracy and precision data from an original GLP validation at 100 BC parameter (reference); re-analyze original raw data from 100 BC validation under decreased BC parameters; perform statistical analyses to compare each new set of data to 100 BC reference; and determine degree of equivalency at each BC parameter, and which BCs are optimal for purposes of analysis.
This poster is written by Bjornstal O, Rogers K, Zhang W, Delhaye R, Malone M, Unger S, Nowatzke W.

FDA’s New Guidance on Biomarker and Patient Reported Outcome Qualification

Article:
This brief review will summarize this guidance, outline the mechanism for ensuring DDT qualification, and suggest areas for further elucidation.
This article is taken from the Journal for Clinical Studies, by Henry J. Riordan, PhD.

The Impact of Decreased Bead Count to Determine MFI Values for Total-Tau, Amyloid Beta 1-42, and Phospho-Tau 181 in Human Cerebrospinal Fluid by Flow Based Fluorometric Immunoassay

Article:
Alzheimer’s disease is the leading cause of human dementia. The lack of diagnostic tests and limited therapeutic options has driven the search for endogenous biomarkers. The INNO-BIA AlzBio3 assay is a multiplex flow-based immunoassay measuring A42, tau, and p-tau in cerebrospinal fluid (CSF). This study assesses assays performance under varying bead count (BC) parameters.
This article is taken from the Journal of Pharmaceutical Companies, by Olaf Bjornstal, Kathryn Rogers, Wei Zhang, Richard Delhaye, Michele Malone, Steve Unger, William Nowatzke.

Improving Academic Leadership and Oversight in Large Industry-Sponsored Clinical Trials: the ARO-CRO Model

Article:
Although numerous models can be entertained, the ARO-CRO model is uniquely structured to meet the demand for greater assurance of integrity in clinical trials and the needs of each stakeholder in the process.
This article is taken from Blood by the American Society of Hematology by Neil A. Goldenberg, Alex C. Spyropoulos, Jonathan L. Halperin, Craig M. Kessler, Sam Schulman, Alexander G. G. Turpie, Allan M. Skene, Neal R. Cutler, and William R. Hiatt, for the Antithrombotic Trials Leadership and Steering Group.

The Impact of DSM-5 on Psychiatric Clinical Trials: Challenges and Opportunities

Article:
This brief review will summarize some of the more salient proposed criteria revisions, their implications for psychiatric trials, and resultant opportunities for psychiatric drug developers.
This article is taken from the Journal for Clinical Studies, by Henry J. Riordan, PhD

Quantitative Determination of Bosentan in Human Plasma by LC/MS/MS

Poster:
Bosentan is indicated mainly for pulmonary hypertension and is a competitive antagonist of endothelin receptors. A bioanalytical assay was developed and validated for bosentan in human plasma to assess the pharmacokinetic properties of bosentan at clinical doses.
This poster is written by Melvin S. Tan, O. Espinosa, R. Orugunty and N. Bhavsar.

A Sensitive Assay for the Determination of Dopamine in Acidified Human

Poster:
Dopamine is a catecholamine neurotransmitter and neurohormone, responsible for conducting signals in the central nervous system, the sympathetic nervous system, and affecting certain glands in the endocrine system. In general, catechols are extremely sensitive to oxidation, requiring acid pretreatment of samples in order to improve stability.
This poster is written by Michael P. Sullivan, Jessica Metcalf, Heather Rush, and Edward Wells.

Quantitative Determination and Validation of Serotonin in Human Plasma and Human CSF

Poster:
Serotonin (5-hydroxytryptamine, 5-HT) is a neurotransmitter involved in many physiological functions (sleep, behavior regulation, hemostasis,and gastrointestinal motility). It also has a role in pathological conditions that include cancer, neurological disorders, and cardiovascular disease. Depending on the condition, certain therapies are designed to either promote serotonin availability or to inhibit it.

Exploration of Automated Sonication and Direct Elution Approaches for the Analysis of Drugs in Dried Blood Spots and Other Matrices

Poster:
As detection sensitivity has improved substantially in recent years, collecting dried blood spots has been reconsidered for broader application instead of collecting plasma or serum. This paradigm shift was compelling for a variety of reasons.
This poster is written by Thomas L. Lloyd, Joseph A. Short and Perry R. Paul.

Innovative Designs for Chronic Pain Trials

Article:
This review highlights innovative trials designs that may improve signal detection for novel therapeutics in chronic pain with a predominantly proof of concept emphasis.
This article is taken from the Journal for Clinical Studies by Henry J. Riordan, PhD and Dr. Michael F. Murphy, MD, PhD.

A Sensitive Assay for the Determination of DOPA and Dopamine in Human Cerebrospinal Fluid (CSF)

Poster:
Dopamine is an important endogenous compound for neurological/physiological health. The relative abundance of DOPA and dopamine can be a useful biomarker for certain therapeutic applications. The low molecular weight, endogenous presence, and relatively low target concentrations of DOPA and dopamine make a quantitative method challenging in biological fluids.
This poster is written by Michael P. Sullivan, Steven Hoehne, and Heather Rush.

The Impact of Site Rater Monitoring and Refresher Training on Enrollment in a MCI Phenotype Trial

Poster:
Direct supervision and ongoing training of raters at the sites by the therapeutic team resulted in better diagnostic specificity and rater reliability. This produced an increase in enrolled subjects due to improved adherence to protocol and scale specific instructions.
This poster is written by Bethanne Friedmann, PsyD, Erin B. Kornsey, MS, Michael F. Murphy, MD, PhD, and Neal R. Cutler, MD.

Validity of Semantic Memory Test as Predictor of Change in ADAS-cog Scores in MCI

Poster:
There are many clinical trials evaluating disease modifying agents in subjects with mild cognitive impairment (MCI). This poster examines the predictive value of a neuropsychiatric test used to characterize the cognitive deficit in MCI in comparison to a well validated assessment commonly used in Alzheimer’s disease trials.
This poster is written by Erin B. Kornsey, MS, Bethanne Friedmann, PsyD, Michael F. Murphy, MD, PhD, and Neal R. Cutler, MD.

Determination of Endogenous Serotonin in Human Plasma

Poster:
Serotonin in human plasma is an important biochemical index for diseases of the central and peripheral nervous systems and is extremely helpful in monitoring certain drug therapies. In patients where conversion to serotonin is inhibited, the concentrations can be extremely low and a significant challenge to measure. The data presented here demonstrates its ability to measure a wide range of baseline levels.
This poster is written by Michael P. Sullivan, and Orlando E. Espinosa.

Site vs. Remote Inter-Rater Reliability of the PANSS and Information Demand

Poster:
The PANSS assessment is the cornerstone of efficacy analysis for a majority of clinical trials. Raters play a significant role in obtaining this data. This is typically site raters, but the use of remote raters is increasing. A multitude of studies fail to demonstrate change in symptoms based on PANSS scoring. It is critical that sources of variability among raters is minimized in order to ensure that PANSS assessments are accurate.
This poster is written by Bethanne Friedmann, PsyD, Henry Riordan, PhD, Erin Kornsey, MS, Evan Braxton, Michael F. Murphy, MD, PhD, and Neal R. Cutler, MD.

A post-hoc Examination of patient characteristics: Implications for enhanced medical surveillance

Poster:
Recent studies in psychiatry have been marked by failed as well as negative trials. One contributory factor may be the enrollment of subjects that technically meet eligibility requirements including threshold scores for disease severity, who nevertheless are suboptimal candidates for study participation when viewed through a prism of historical and clinical information not captured by a study database.
This poster is written by Bethanne Friedmann, PsyD, Henry J. Riordan, Ph.D., Erin B. Kornsey, MD, Kenneth Williams, MD, Kevin Cox, MD, Neal R. Cutler, MD, and Michael F. Murphy, MD, PhD.

Formation of a Global CRO Council for Bioanalysis

Article:
This article provides recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s in a white paper format.
Published by: the Global CRO Council for Bioanalysis.

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