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…accelerating clinical trials 
TAB Clinical CNS Experience
…accelerating clinical trials 
Who We Are 
17 years as a specialty, full service CRO 
Pre-IND stage development to post-ma...
…accelerating clinical trials 
Medical Writing for IND, protocols, Final Study Reports and NDAs 
Knowledge of viable sites...
…accelerating clinical trials 
Selection of Sites for Experience and Enrollment Capabilities 
Dedicated and Experienced CR...
…accelerating clinical trials 
ADHD/ADD 
Alzheimer's 
Anxiety 
Bi-Polar 
Cognitive Disorders 
Epilepsy 
5 
Major Depressio...
…accelerating clinical trials 
•Brivaractam - This UCB study was the largest Phase 3 study conducted in epilepsy patients ...
…accelerating clinical trials 
•Gammunex – Phase III study for Grifols Chronic inflammatory demyelinating polyneuropathy (...
…accelerating clinical trials 
Michael Ferguson, President & CEO 
• 25 Years in the Pharma Industry 
• Previous senior lev...
…accelerating clinical trials 
9 
Accelerating Clinical Trials 
Contact Michael Ferguson, President & CEO 
Phone: 919.319....
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Tab Clinical CNS Experience

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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.

Published in: Health & Medicine
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Tab Clinical CNS Experience

  1. 1. …accelerating clinical trials TAB Clinical CNS Experience
  2. 2. …accelerating clinical trials 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 2
  3. 3. …accelerating clinical trials 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 3 Capabilities
  4. 4. …accelerating clinical trials 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 4 Critical Success Factors
  5. 5. …accelerating clinical trials ADHD/ADD Alzheimer's Anxiety Bi-Polar Cognitive Disorders Epilepsy 5 Major Depression Pain Parkinson PTSD Schizophrenia Smoking Cessation Stroke CNS Therapeutic Experience
  6. 6. …accelerating clinical trials •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. 6 CNS Therapeutic Experience (Examples)
  7. 7. …accelerating clinical trials •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 7 CNS Therapeutic Experience (Examples)
  8. 8. …accelerating clinical trials 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 8 Leadership
  9. 9. …accelerating clinical trials 9 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 Follow TAB Clinical:

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