PYSCHIATRY RESEARCH TAILOR-MADE FOR PATIENTS, CLINICIANS, AND REGULATORS ALIKE
Without rigorous design and strategic planning, psychiatry research walks a fine line between hard science and subjectivity. That’s why Worldwide designs studies that balance the needs of stakeholders at every stage of the process.
A TEAM THAT UNDERSTANDS—AND MANAGES—ALL ANGLES
By developing close working relationships with key clinical leaders and engaging a broad network of clinicians globally, Worldwide fosters improved participation and quality for psychiatry clinical trials. To go a step further by also appealing to patients and regulators, you need a dedicated team with experience navigating a narrow road—a team that speaks a language everyone understands, and designs and executes a study that balances everyone’s priorities.
Worldwide has a proven track record and wealth of experience within our therapeutically aligned team. Our clinicians, scientists, staff and project teams have extensive experience in conducting all phases of clinical trials with more than 50 psychiatry studies enrolling over 7,000 patients globally.
BARTOSZ JANIKOWSKI, MD
SENIOR 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.
VICE PRESIDENT, PROJECT MANAGEMENT, PSYCHIATRY AND NEUROLOGY
With 25 years of experience, Lisa has overseen projects ranging from small, complex Phase I and Phase II studies to global Phase III, IV, and expanded access trials with adult, geriatric, and pediatric populations. Lisa oversees neuroscience programs and personnel and develops processes and tools for high-quality project delivery. She provides operational oversight for Worldwide’s neuroscience portfolio, line management to Global Project Leads, and supports corporate and process improvement initiatives. Her areas of expertise include psychiatry (schizophrenia, depression, bipolar, anxiety, and ADHD), analgesia (post-operative, osteoarthritic and neuropathic), and neurology (Parkinson’s disease, restless leg syndrome, and Alzheimer’s disease).
EXECUTIVE DIRECTOR, PROJECT MANAGEMENT, PSYCHIATRY AND NEUROSCIENCE RARE DISEASES
Richard Koenig is Executive Director, Project Management, Psychiatry and Neuroscience Rare Diseases for Worldwide Clinical Trials. He has more than two decades of clinical research experience, specializing in CNS disorders and extending to a broad range of therapeutic areas. His portfolio spans all phases of study and ranges from small regional projects to global-scale programs. Whether working with a small biotech or a large pharmaceutical company, he applies localized attention to sponsor needs.
SENIOR DIRECTOR OF CLINICAL PROJECTS, CLINICAL ASSESSMENT TECHNOLOGIES
Rolana Avrumson has over 22 years of clinical experience, including over 13 years in clinical trial research. As leader of the Clinical Assessment Technologies team for Worldwide Clinical Trials, Rolana’s primary responsibilities include oversight of the operational and clinical conduct of assigned studies, including protocol review, rater, patient, site staff and CRA training, rater reliability activities, PRO development, central reviews, data surveillance, data quality reporting, and scale and eCOA management. Rolana has held significant roles in global and domestic phases I-IV trials across a multitude of indications including those in CNS, rare disease, general medicine, cardiovascular and oncology therapeutic areas. As a clinician in applied practice, Rolana has over 22 years of experience administering, scoring, and analyzing assessments.
Worldwide is one of the few full-service CROs that provides rater training, scale management, and management of electronic Clinical Outcome Assessments (eCOA/ePRO) vendors. We’ve conducted rater training and data surveillance for hundreds of domestic and international Phase I-IV trials and trained more than 7,000 raters.
Disease heterogeneity and a lack of definitive markers within psychiatric indications make selecting the right sites to identify the right patients imperative. Worldwide has a robust, carefully cultivated global network of qualified psychiatric sites with strong trial experience in numerous patient populations.
Our founders and staff members have made substantial contributions to trial methodology in depression and psychiatric indications for the past 30+ years, authoring seminal citations and analyzing studies in all phases of development–meaning we can bring you an unparalleled understanding of the complexities of psychiatric trials to help mitigate risks inherent to this field.
From major depressive disorder with psychomotor retardation to acutely psychotic schizophrenia, Worldwide has done it all. We’ve worked with compounds such as psychedelics, stimulants, reuptake inhibitors, neurotoxin proteins, atypical antipsychotics, long-acting injectables, and many more.
A laser-like focus on the things that make psychiatry research tick
When we decide to do something, we do it well. Worldwide set out to improve psychiatric and neurologic health for patients around the world a long time ago. Now, our commitment to advancing the field through meaningful, standard-setting contributions is perhaps our greatest legacy.
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.
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
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.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
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
Our Team of Neuroscience Functional Experts
Vice President, Central Nervous System Therapeutic Area Lead, Medical Affairs
Chief Development Officer
Executive Director, Project Management, Psychiatry and Neuroscience Rare Diseases
Senior Vice President, Project Management, Neuroscience
Executive Director, Project Management, Franchise Area Lead, Analgesia, Addiction, and Neurology Rare Disorders
Vice President, Scientific Solutions, Neuroscience
Executive Director, Project Management, Alzheimer’s Disease and other Dementias
Executive Director, Project Management, Neurology and Rare Diseases
Chief Medical and Scientific Officer
Vice President, Project Management, Psychiatry, Alzheimer’s Disease and other Dementias
Vice President, Neuroscience, Scientific Solutions
Executive Director, Project Management, Alzheimer’s Disease and other Dementias
Global Head of Regulatory Strategy
Vice President, Project Management, Psychiatry and Neurology
Senior Vice President, Medical & Scientific Affairs
Senior Director of Clinical Projects, Clinical Assessment Technologies