Transcript Slide 1
Welcome to Sterling IRB Our Total Commitment. Your Total Confidence. 2013 About Sterling IRB For more than 20 years, Sterling has helped lead the way in safeguarding the rights and welfare of clinical research participants. Our approach places the focus on your specific needs – complete with caring, responsive service you can always count on. This means being there for you with the guidance and answers you need when you need them – all backed by a commitment to the highest standards of human subject protection and regulatory compliance. STERLING IRB 2 History of Sterling IRB • • • Sterling IRB was established in January, 1991 Sterling IRB has a strategic partnership with Veritas IRB to provide our clients with oversight for research sites in Canada and Mexico Sterling IRB has experience in reviewing: • • • • • • FDA and OHRP regulated studies Phase I-IV drug studies in all therapeutic areas Device studies Biologic studies Observational and Registry studies Social-Behavioral studies STERLING IRB 3 History of Sterling IRB cont. • Sterling reviews studies for: • • • • • • • Pharmaceutical and Biotechnology companies Medical device companies Contract Research Organizations Federal agencies Hospital groups Universities Individual investigators STERLING IRB 4 Sterling IRB Capabilities • Full AAHRPP Accreditation until March, 2018 • Comprehensive review services in U.S., Canada, Mexico • Multiple IRB meetings weekly • • Dedicated CIP certified Account Manager assigned to your study as a single point of contact SilverLink Web Portal – Ensuring fast, secure document submission and retrieval STERLING IRB. 5 Sterling IRB Capabilities cont. • Protocol Review within 5 business days • Site Review within 24 hours • Consent editing and preparation • Translation services • Expedited Review • • • • New research that meets FDA criteria Minor changes to consent and protocol Recruitment materials PI for an approved, ongoing research study STERLING IRB 6 Sterling Board Roster • Sterling currently has one Board that meets twice weekly • • • Medical expertise on the IRB includes: • • • • • • • Oncology / Hematology Ophthalmology Cardiology Psychiatry Infectious Disease OB/GYN Allergy / Asthma Other expertise includes: • • • • Clergy Ethicist Pediatrics Medical credentialists Sterling IRB has an extensive network of consultants if additional medical expertise is required to review a protocol STERLING IRB 7 IRB Registration • Sterling IORG (“Institution or Organization”) Number IORG0001354 • • • • Institutional Official: Kathye Richards, CIP Contact Person: Alison Alesi, JD, CIP Registration Expires April 12, 2016 Sterling has one Institutional Review Board • • • IRB Chairperson: Steven Saltzman, MD, FACOG IRB Registration Number IRB00001790 Registration includes information required for IRBs reviewing FDA-regulated products STERLING IRB 8 To learn more about Sterling’s full capabilities and trusted approach, please contact: Kathye Richards, CIP Director of Client Services 1.888.636.1062 [email protected] 2013