Central Nervous System

Neurologic disorders, such as Alzheimer disease, Parkinson disease, and amyotrophic lateral sclerosis, affect millions of people worldwide and impose a significant burden on patients, caregivers, and health care systems. Although new treatments are urgently needed, and progress has been achieved by neurological research efforts, still the development of novel therapies is hindered by limits in understanding individual neurologic diseases and challenges in conducting clinical research.

As a result, researchers and clinicians face a unique set of challenges during the development of pharmacologic agents for the treatment of neurologic disorders. One of these challenges is the stringent requirements imposed by regulatory bodies on all phases of drug development. Our Regulatory and Strategic Development (RSD) experts can guide you through regulatory requirements, including approval by multiple institutional review boards, development of complex study designs, training investigators, and establishing contracts with other agencies and clinical centers to recruit eligible patients and implement the study protocol.

Working with Clinipace and TEMPO™, our fully-integrated technology platform, during study management can help with another challenge CNS trials face—patient recruitment. The ability to view and monitor the number of patients enrolled at every investigator site can help ensure the study is on track right from the start. If enrollment is below expectations, study teams can adjust their strategies and quickly make decisions to help drive enrollment.

Furthermore, the use of TEMPO for functions like endpoint adjudication and remote site monitoring reduces cost, improves accuracy, and enables faster study close-out. Real-time data access also enables adaptive study designs that require fewer patients and increase likelihood of successful outcomes, and provides early identification of safety signals.

In neurology, a new model of drug discovery and development is emerging. Advances in genetic and molecular technology will increase the ability to understand and disrupt disease progression. Such advances may also aid in detecting early onset of disease and evaluating therapies in development. Another positive sign for CNS drug development is the emerging collaborative research environment that leverages data and innovative approaches to improve research outcomes.

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