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IDS Support (Investigational Drug Service Group Support)

An investigator starts research in a new field with faith, a foggy idea, and a few wild experiments. Eventually the interplay of negative and positive results guides the work. By the time the research is completed, he or she knows how it should have been started and conducted.”          

                                                                                          -Donald Cram

Bring us in when…

  • An IDS audit has ended with multiple findings

  • Your IDS performance must meet new expectations

  • GCP’s are an issue

  • Procedures need to be enhanced

  • Shipping cold or frozen investigational drug must be done

  • PI’s store their own drug outside of the Pharmacy or IDS

  • Good documentation practices are an issue

  • Clinical Pharmacist to Investigational Pharmacist evolution is needed

  • Randomization complexity may become an issue

  • Roles and responsibilities of PI, Clinical Research Coordinator, Investigational Pharmacist, CRA, Sponsor Monitors are blurred or require clarity

  • Deeper training is needed

  • SOP gap analysis should be performed

  • SOPs are to be created/implemented with training

  • Joint Commission Guidelines need to be built into SOPs

  • Study binder review, binder content standardization, training on GCP/GMP overview, roles to responsibilities clarity

  • SOP enhancement training is needed

  • Audit readiness and IDS quality system enhancement is a must have

  • Accountability problems have arisen

  • Trust must be built between the IDs the PI’s and Investigational Teams

  • IDP destruction has been found to be deficient


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