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.

1. …accelerating clinical trials
TAB Clinical

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
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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
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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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Rapid Deployment of CRF using latest Web Technologies
CFR Part 11 compliant EDC System with Help Desk Support
• Central Randomization (no need for separate IVRS)
• e-Patient Reported Outcomes (email-prompted via web)
• Medical Coding (within EDC or in SAS)
CDISC Compliant outputs
• Clinical Data Acquisition Standards Harmonization (CDASH )
• Analysis Data Model (ADaM)
• Study Data Tabulation Model (SDTM)
SAS 9.3 (PC-WINDOWS)
DEFINE.XML to support regulatory submission
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Data Services

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Concept Protocol to Final Protocol – 2 Weeks
Final Protocol to CRF Design – 2-3 Weeks
• Including eCRF and DB design
• eCRF amendments – <1 Week
LPLV to DB Lock – 1 Week
DB Lock to Top-line Results – 2 Weeks
DB Lock to Full Statistical Package – 8 Weeks
DB Lock to First DRAFT of FSR – 12 Weeks
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Building on Past Success

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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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Next Steps
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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