Chesapeake IRB provides independent IRB services for major pharmaceutical companies, universities, individual researchers, academic medical centers and community hospitals.
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