Founded nearly two decades ago TAB Clinical has been guided by the three standards of responsiveness, cost and experience. We are staffed to immediately respond to your clinical needs and thus be more responsive than other CROs. By design, TAB Clinical built a relatively flat organization allowing us to better control operating costs and pass along the savings to our sponsors. TAB Clinical has always retained the most experienced personnel by therapeutic area to ensure your study runs smoothly.

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TAB Clinical CNS Experience

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Who We Are
17 years as a specialty, full service CRO
Pre-IND stage development to post-market approval
Multiple therapeutic areas of experience
Experienced with Clinical Trial Agreements and Contracts
Large database of sites, labs and vendors
Strong experience with academic and central IRBs
Multiple languages and country capabilities
Worked with over 120 pharma and bio-tech companies on more than 300 trials
Clinical and Post Market Drug Safety and Pharmracovigilance Support
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Medical Writing for IND, protocols, Final Study Reports and NDAs
Knowledge of viable sites
Execution of Investigator Meeting and Site Study Training
Development of enrollment strategies
Experience with vendors to support packaging and shipments of IP
Experienced CRAs (Specific to Sponsors Study)
Experienced Clinical Project Managers
Strong In-House monitors to support CRAs and Data Management
Medical Monitors with Experience in Specific Therapeutic Areas
Full Suite of SOPs spanning Clinical, Regulatory, DM/Stats, Medical Writing
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Capabilities

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Selection of Sites for Experience and Enrollment Capabilities
Dedicated and Experienced CRO Team that stays on the job from beginning to end
Initiation and Training focusing on critical areas
Detect and Manage Potential Issues before they become Problems
Close communication with and management of sites
Selection of Central Labs and Packaging Vendor
Monitoring of Sites for Compliance to Protocol
Retraining of Investigators
Continuous onsite and offsite SDV and Query Resolution to enable quick data lock
Dedicated biostatistics team to produce final analysis results on time
Experienced Medical Writing team to author Protocol, Final Study Report, and NDA
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Critical Success Factors

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ADHD/ADD
Alzheimer's
Anxiety
Bi-Polar
Cognitive Disorders
Epilepsy
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Major Depression
Pain
Parkinson
PTSD
Schizophrenia
Smoking Cessation
Stroke
CNS Therapeutic Experience

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•Brivaractam - This UCB study was the largest Phase 3 study conducted in epilepsy patients with partial-onset seizures. Overall, the brivaracetam development program has involved over 3,000 people and offers over eight years of clinical experience with some patients.
•This Phase 3 study was a randomized, double-blind, placebo-controlled, multicentre, parallel- group study to evaluate the efficacy and safety of adjunctive brivaracetam (100 and 200 mg/day) compared to placebo, over a 12-week treatment period, in 768 randomized focal epilepsy patients (aged 16 to 80 years) with partial-onset seizures, not fully controlled despite treatment with one or two concomitant AEDs.2,7 The primary endpoint for the European regulatory authorities is the 50% responder rate for partial-onset seizure frequency compared with placebo, over the treatment period standardized to a 28-day duration. The primary endpoint for the FDA is the percent reduction
•Provided Clinical Project Management on a Global basis
•Levetiracetam (Keppra) – Multiple Epilepsy studies for both adults and pediatrics.
•Neupro – Parkinson study – provided monitoring and CPM for multiple studies.
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CNS Therapeutic Experience (Examples)

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•Gammunex – Phase III study for Grifols Chronic inflammatory demyelinating polyneuropathy (CIDP). Gamunex®-C is indicated for the treatment of CIDP to improve neuromuscular disability – provided global CPM, monitoring, data management and vendor management.
•ADHD – Pediatric and Adult
•Pain Management – Multiple Ph II-III studies
•Migraine – Ph I, II and III studies for multiple therapies
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CNS Therapeutic Experience (Examples)

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Michael Ferguson, President & CEO
• 25 Years in the Pharma Industry
• Previous senior level management with Beecham, Searle, Baxter and AMSCO
• Focusing on Clinical Lab, Animal Research, Manufacturing and all Phases of Clinical Drug and Device Development Manages Clinical Operations, Drug Safety and PV in US and EU
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Leadership

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Accelerating Clinical Trials
Contact Michael Ferguson, President & CEO
Phone: 919.319.0067 Ext. 23
Email: mferguson@tabclinical.com
Website: http://tabclinical.com/
Address: 2000 Regency Parkway, Suite 255 Cary, NC 27518
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