TAB Clinical Overview
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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.
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TAB Clinical Overview
- 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 2
- 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. …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. …accelerating clinical trials 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 5 Data Services
- 6. …accelerating clinical trials 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 6 Building on Past Success
- 7. …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 7 Leadership
- 8. …accelerating clinical trials8 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 Follow TAB Clinical: