BALANCING THE SCIENTIFIC & HUMAN ASPECTS OF NEUROSCIENCE CLINICAL RESEARCH
Neuroscience research demands an appreciation for both the human-focused and scientific aspects of clinical research. Worldwide approaches each clinical trial with a thoughtful, patient-centric plan.
A STRONG LEGACY OF SCIENCE AND MEDICINE
Worldwide Clinical Trials has helped advance neuroscience research since the advent of cholinesterase inhibitors in the 1970s. Today, we continue that decades-long tradition of clinical trial excellence by combining our extensive experience with our persistent desire to innovate and excel – and it shows in our many long-term partnerships and collaborations throughout the industry with small to large organizations. We’ll help take your compound from Phase I through Phase III, and you’ll get the full force of our medical and scientific prowess in the form of collaborative, customized project teams with phase- and indication-specific expertise.
TAMARA AST, PHD
SENIOR VICE PRESIDENT, PROJECT MANAGEMENT, NEUROSCIENCE
Tamara Ast, PhD, Senior Vice President for Project Delivery Services in Neuroscience at Worldwide Clinical Trials, oversees a team of experienced neuroscience clinical research professionals for neurological, psychiatric, and pain indications. With more than 20 years’ industry experience, she has provided leadership for project management and operations delivery at Worldwide. Her affinity for working in multicultural environments has contributed to her commitment to diversity. She empowers large teams across multiple regions globally to deliver regulatory, scientific, medical, and operational excellence to our customers.
HENRY J. RIORDAN, PHD
CHIEF DEVELOPMENT OFFICER
Henry is one of the original team members at Worldwide. A prolific author of more than 120 peer-reviewed abstracts, articles, chapters, and books, he has advanced training and expertise in quantitative methods, biostatistics, experimental design, neurophysiology, neuroimaging, and clinical neuropsychology. He oversees the CNS, General Medicine, Cardiometabolic, and Oncology Franchises and drives Worldwide’s company vision of being the leader in the application of rigorous methodology and medically and scientifically advanced drug development processes. Henry has written numerous protocols in neurologic, psychiatric, and analgesic indications across all phases of development. He has also worked in the departments of neurology and psychiatry at Jefferson, the University of Pennsylvania, and Dartmouth medical schools.
BARTOSZ JANIKOWSKI, MD
VICE PRESIDENT, MEDICAL & SCIENTIFIC AFFAIRS
Bartosz is a board-certified psychiatrist and psychotherapist with more than two decades of clinical experience, including 18 years in therapeutic research and development. He manages and coordinates the activities of the Medical Affairs group across all therapeutic areas. In prior roles, Bartosz was responsible for direct supervision of all medical monitoring and scientific services, and served as medical advisor for numerous pediatric and adult trials as the neuroscience leader in MDD, anxiety, bipolar disorders, schizophrenia, MCI, and other neurology studies. Bartosz has been extensively involved in CNS drug development program designs, protocol development, medical and safety management of global clinical studies, and CNS rater training and qualification programs.
IDIL CAVUS, MD, PHD
EXECUTIVE DIRECTOR, CENTRAL NERVOUS SYSTEM THERAPEUTIC AREA LEAD. MEDICAL AFFAIRS
Dr. Cavus’s medical career exceeds 30 years and includes more than two decades in clinical research specializing in neurological, psychiatric, and rare/orphan disorders. Prior to joining Worldwide, Dr. Cavus, an expert in basic and translational medicine neuroscience expertise, held positions of increasing responsibilities in protocol and safety oversight at Pfizer, Bristol-Myers Squibb, and Alexion. She has been a grant reviewer for the U.S. National Institute on Drug Abuse for the past five years and is an adjunct professor at Yale University. Dr. Cavus earned her Ph.D. in neuroscience from Northeastern Ohio College of Medicine/Kent State University. She’s received awards from Pfizer, Yale University, and the U.S. National Institutes of Health and is credited with more than 50 publications and presentations.
5 Ways to Adapt Your Neurodegenerative Disease Trial to the World of COVID-19
Karen Hill and Nancy Newark, RN
How can you pivot your trial operations during COVID-19 disruptions? Find out in our eBook on adapting neurodegenerative studies.Learn More
Considerations Regarding Non-Inferiority Studies
A case study in multiple sclerosis.Learn More
Patient Segmentation in ALS Studies
Does genotypic vs. phenotypic segmentation make sense in the context of an amyotrophic lateral sclerosis (ALS) study?Learn More
Our team of experts has undisputed experience in translating preclinical findings into thoughtful, efficient clinical development in a variety of therapeutic areas, including central and peripheral nervous system disorders. We provide a solid foundation in imaging technology and novel measurement tools, as well as the most imaginative minds in the business for study design and recruitment, to extract valuable data from practical, well-run programs.
Difficulty demonstrating changes in the pathophysiology of the disease, varied symptoms and molecular targets for a single diagnosis, and the heavy reliance on patient-reported outcomes rather than biomarkers can make neuroscience studies logistically, statistically and financially challenging. Our state-of-the-art clinical pharmacology unit and top-ranking bioanalytical laboratory enable objective biomarker development, quick sample processing, and intelligent decision-making for early-phase research.
Worldwide has talent and infrastructure in more than 60 countries, which means access to hard-to-find patients and plenty of practice navigating the variations in regional standards of care. With our established regulatory partnerships and cultural and geographic expertise, we can help avoid potential pitfalls and anticipate any local regulatory concerns.
This team provides rater training, scale management, and management of electronic outcomes solution vendors. The CAT group is seamlessly integrated with the other functional teams to yield efficiencies in budgets, time lines, communications, common resources, and shared systems, while increasing overall data quality.
Understanding the nature of neuroscience research
Worldwide offers collaborative training of participating clinicians, unique approaches to data analysis and endpoint development, a global footprint with tried-and-true research partners in more than 60 countries, and uncommon expertise in clinical pharmacology and bioanalytics for early-phase neurocognitive research. These practical assets dovetail with our empathetic and people-friendly approach to trial design that fits into patients’ lives.
Neuroscience Indication Experience
- Our Cognitive Task Force and scale development work speak volumes about our commitment to Alzheimer’s and dementia research. At Worldwide, we design and execute rigorous, compassionate studies we’d be happy to have our own family and friends take part in, carefully protecting the patient experience and maintaining compelling data integrity to get products to market even in this competitive research space.
Worldwide was founded to help improve research for neurology patients. Decades later, we’ve done it all, working on a dizzying number of compounds and indications in every phase. Now Worldwide is one of the few full-service CROs that provides integrated rater training, scale management, bespoke assessment development, and a broad range of other highly specialized consulting services in addition to our top-notch global network of study execution experts.Learn More
Worldwide leads the way in best practice development for pain and addiction research. We have seen it all, which helps us offer the right blend of tried-and-true logistics, creative study designs, and thoughtful outcomes measures to augment objectivity in this otherwise nebulous field of research.Learn More
Rare neurological diseases each have unique hurdles for developing compelling outcomes assessments that can demonstrate efficacy with small patient populations. Worldwide is a leader in rare disease recruitment, novel endpoint development, and innovative study designs. We deliver specialty studies that apply our overarching knowledge in neurological conditions and rare diseases to thoughtful study designs, respecting patient communities and generating the data sponsors need to advance their compound to market.Learn More
A crowded research space makes it difficult to weed the subjectivity out of the science—which demands a CRO with psychiatry know-how from the ground up and the top down. Our proven track record for patient recruitment and engaged investigator networks speaks volumes about our expertise in psychiatric trial development and execution.Learn More
Our Team of Neuroscience Functional Experts
Vice President, Project Management, Psychiatry, Alzheimer’s Disease and other Dementias
Executive Director, Central Nervous System Therapeutic Area Lead, Medical Affairs
Director of Clinical Projects, Clinical Assessment Technologies
Chief Medical and Scientific Officer
Vice President, Neuroscience, Scientific Solutions
Vice President, Medical & Scientific Affairs
Chief Development Officer