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.

1. …accelerating clinical trials
TAB Clinical’s Complete GI Platform

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
Data Management through CFR Part 11 Compliant EDC Platform
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. …accelerating clinical trials
Medical Writing for IND, protocols, Final Study Reports and NDAs
Knowledge of Multi-Site Specialty Specific and Academic 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. …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
Ongoing Training 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. …accelerating clinical trials
Susan Cloninger, BS, RAC has 20+ years experience in the pharmaceutical and medical device industry. As a Clinical Project Manager, Susan leads TAB Clinical teams of monitors and data managers. Susan’s knowledge of regulatory, protocols, IRBs, ICF and TMF all made her a valued asset to this and other studies.
Susan’s career includes:
 Maintaining Regulatory Affairs Certification (RAC) since 1997
 Serving as a member of the North Carolina Regulatory Affairs Forum (NCRAF) for 15 years
 Holing the office of President of NCRAF
 Serving as Quality Assurance Manager for the Copernicus IRB training investigators and study coordinators on GCP and ICH
 Having strong therapeutic knowledge and experience in GI, CNS, Cardiology and Metabolics
 Successfully leading a Class II medical device manufacturer through the process to gain the CE mark following implementation of a ISO 9001 Quality System
 Working with large and small pharma companies on Phase I, II and III studies in the US and globally
 Developing internal SOPs and trains study personnel for TAB Clinical
5
Project Management

6. …accelerating clinical trials
Being expert in the GI therapeutic area was not enough for TAB Clinical. We were determined to develop a platform for pharma and biotech companies that address ALL of their needs when executing a clinical trial. A true FULL SERVICE company.
Site recruitment and patient enrollment stands as the number one challenge for sponsors - costing them valuable time and money. TAB Clinical has packaged their CRO services with RT CRO and GAME which is a national site management provider.
6
Complete GI Platform

7. …accelerating clinical trials
TAB Clinical Saves Sponsors Time and Reduces Trial Cost
12 Focused GI Sites Across the US
• All under 1 contract
• All under 1 PI
• All under 1 IRB
125 Physicians with Clinical Trial Experience and Access to 250,000 Active Patients
• Phase I-III Studies
• Phase IV Studies
• PK Studies
• Registry Studies
• Truly Rapid Study Start Up
• Rapid patient recruitment
7
Complete GI Platform

8. …accelerating clinical trials
IBD
IBS
GERD
Reflux
Gastroparesis
Constipation
8
GI Therapeutic Experience (Partial)
Crohns
Helicobacter Pylori
C-Dif
UC
Gastrpesophageal Reflux
Ulcerative Proctitis

9. …accelerating clinical trials
Michael Ferguson, President & CEO
• 25 Years in the Pharma Industry
• Previous senior level management with Beecham, Searle, Baxter and AMSCO/Steris
• 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
9
Leadership

10. …accelerating clinical trials
10
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: