The CNS Company™
The CNS Company™ is the division of TCTC Group™ that is comprehensively experienced in providing high-quality clinical research services to companies operating in the areas of neurology, psychiatry and CNS orphan diseases. Our team has a depth of experience in the particular challenges posed in CNS clinical trials.
CNS clinical studies are very different from those conducted in other therapeutic areas as, in general, there are few hard end points, it is challenging to identify a homogeneous population, and many of the rating scales rely on subjective clinical assessments and questionnaires. If not managed appropriately, with up-front validation of scales and rater training, this may lead to difficulties with inter-rater variability leading to inconsistent results.
The CNS Company™ staff have a wealth of experience across many CNS indications and with numerous rating scales and assessments. They understand how to manage the challenges these present in clinical trials.
In addition to offering the full-service support, The CNS Company™ also offers expertise in the following:
Orphan drug designation
Preparation of scientific advice packages
Preparation of Special Protocol Assessment packages
Protocol design & Endpoint selection
Regulatory strategies for the particular disease under investigation and type of drug
Scientific literature review and searches
The design of an efficient and effective development programme
Review of documentation and scientific due diligence
Detailed feasibility and in-depth analysis of results to guide trial design, site selection and recruitment strategy.
Having worked closely with the leading experts in CNS diseases and with leading centres of excellence around the world, The CNS Company™ can deliver patient recruitment on time.
In our most recent study in a CNS orphan disease:
• Patient recruitment was 37% faster than the average of 4 published studies and 26% faster than the fastest reported, demonstrating our delivery of study milestones through unsurpassed patient recruitment.
• 92% of patients completed the study and 82% were in full compliance demonstrating excellent patient retention.
Therapeutic Areas experience
Traumatic Brain Injury
Other areas of neurology and psychiatry include Tardive Dyskinesia, Motor Neurone Disease, Myotonic Dystrophy, Bipolar Disorder, Obsessive Compulsive Disorder, Borderline Personality Disorder, Tourette's Syndrome and Attention Deficit Hyperactivity Disorder (ADHD).