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

President of Neuroscience Business Unit

Tamara Ast, PhD, President of the CNS Business Unit at Worldwide Clinical Trials, oversees a team of experienced neuroscience clinical research professionals for neurological, psychiatric, and pain indications. With more than 25 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.

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.

Turning basic research into meaningful endpoints and data

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.

Speaking the language of global research and regulatory bodies

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.

Developing early-stage solutions to enable novel therapy advancement

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.

Clinical Assessment Technologies (CAT) Capabilities

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.

Neuroscience Experience

Alzheimer’s Disease & Dementia

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.

Neurology

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.

Pain & Addiction

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.

Rare & Other

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.

Psychiatry

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.

Client Testimonials

Hear from our past customers about their experience with Worldwide

“Due to their dedication, expertise, and drive, we have, as a team, submitted 14 sites in 3 countries and put together a 200+ page IMPD and a high-quality submission.”

Mid-size biopharmaceutical customer Director, Clinical Operations

Neuroscience Resources