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.

LISA LEUZZI

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).

RICHARD KOENIG

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.

ROLANA AVRUMSON

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.

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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. 

Neuroscience Experience

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.

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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.

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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.

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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.

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Our Team of Neuroscience Functional Experts