FAQs
Q: Which IRB do you submit protocols to?A: The Bio-Kinetic Institutional Review Board is dedicated to reviewing protocols submitted by Bio-Kinetic. The IRB is made up of professionals from the local Springfield area.
Q: How often does the IRB meet?
A: The Bio-Kinetic IRB meets approximately every 3 weeks. Protocols must be submitted to BKCA at least 1 week prior to the IRB meeting. This allows for time to copy and mail copies of the protocol to each member for their review.
Q: What is your normal lead time for study start-up?
A: The normal lead time is 4-6 weeks. This time may vary depending on your specific needs.
Q: How far in advance do I need to reserve dates for my study?
A: We are generally booking studies 60-90 days in advance. The more advance the notice, the better we can meet your study specifications.
Q: Have you been audited by the FDA?
A: The FDA has audited Bio-Kinetic and the IRB several times. All FDA reports are on file for your review. In addition to the FDA, BKCA goes through approximately 20 sponsor audits per year.
Q: Do you allow sponsor monitors to observe study procedures?
A: Yes. We encourage our sponsors to attend at least the first if not each study product administration.
Q: When will CRFs be completed?
A: Bio-Kinetic's standard policy is to have CRFs complete and 100% verified 2 weeks after the last study visit is complete.