Chesapeake IRB
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Chesapeake IRB provides independent IRB services for major pharmaceutical companies, universities, individual researchers, academic medical centers and community hospitals.
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Chesapeake IRB
- 1. Chesapeake IRB Quality Approach 7063 Columbia Gateway Drive Columbia, MD 21046 410-884-2900 www.chesapeakeirb.com
- 2. 7063 Columbia Gateway Drive, Columbia, MD 21046 410-884-2900 Chesapeake IRB provides independent IRB services for major biopharmaceutical companies, universities, individual researchers, academic medical centers and community hospitals.
- 3. Deliver Risk-Management Based IRB Oversight: Proven & Validated Flexible & Responsive Knowledgeable & Innovative Focused on Quality Scalable Trusted partner who works with you to leverage best practices across the research enterprise while you retain control Chesapeake IRB’s Value Proposition 7063 Columbia Gateway Drive, Columbia, MD 21046 410-884-2900
- 4. Risk Management-Based Approach People Processes Technologies Individual education and certifications augmented by active participation in industry forums. Unique CIP exam course aids certification pass rate. Focused on Continuous Improvement to efficiently deliver Quality Oversight (Kaizen). User-friendly tools leverage best practices across the research enterprise and provides scalable, operational leverage. 7063 Columbia Gateway Drive, Columbia, MD 21046 410-884-2900
- 5. IRB Executive Committee Conflict of Interest Committee SAE Subcommittee CIRBI Change Control Board Address policy issues arising across board meetings Recommend uniform application of policy or procedural changes Independently review policies dealing with internal and external COIs Review SAEs to assess impact on active studies Structured oversight process to oversee and control changes to the CIRBI environment Continuous Process Improvement Focus: IRB Related Committees 7063 Columbia Gateway Drive, Columbia, MD 21046 410-884-2900
- 6. CIRBI: Our “Quality System” Platform (Click Commerce) Visibility: Provides real-time IRB status tracking Transparency: All actions auditable 24X7, via secure, encrypted, role- based access Dedicated point of contact provides individualized and quality collaborations with clients Supports CAPA (Corrective & Preventive Action) 21 CFR Part 11 Compliant/Validated IRB platform 7063 Columbia Gateway Drive, Columbia, MD 21046 410-884-2900
- 7. CIRBI Impact Enhances operational efficiencies and timeliness Leverages best practices across the enterprise SmartForm Technology: Reduces errors, improves quality, streamlines submission Improves customer satisfaction – 24x7 access Audit trail capability supports compliance Scalability supports growth Supports client needs (external monitor visit, ad hoc reports, etc.) 7063 Columbia Gateway Drive, Columbia, MD 21046 410-884-2900
- 8. Quality-Driven IRB Services Five weekly meetings to ensure timely review Daily expedited review: 24 hour PI review IRB review within 4 business days of submission On-call consultation for study submissions Efficient initial ICF process (negotiated template) Minimizes PI Staff Burden No ICF re-issue at Continuing Review Certified language translations of approved material 7063 Columbia Gateway Drive, Columbia, MD 21046 410-884-2900
- 9. Contact Chesapeake IRB Ruth Boulter Vice President, Business Development rboulter@irbinfo.com Address: 7063 Columbia Gateway Drive Columbia, MD 21046 410-884-2900 www.chesapeakeirb.com