The portfolio management team provides support with all aspects of the clinical trial life cycle in collaboration with our CTI fiscal, regulatory, and coordination teams, including:
We aim for 90 business days from the beginning of startup to the study initiation visit. The timeline is dependent on the complexity of the study and sponsor responsiveness. We require all final versions of the necessary regulatory documents to begin work (this includes current protocol, IB, approved ICF templates, study manuals for ancillary review).
Not at this time.
Yes. We use our local IRB for ceding review/approval prior to submitting to a central IRB of record. The local IRB may be used as the IRB of record for investigator-initiated studies.
Yes. Our site requires a central IRB to be used as the IRB of record with all multi-site, industry sponsored trials.
Yes. We have an institutional process that requires internal reviews by various ancillary departments (Pharmacy, Lab, Radiology, Clinical trials billing, Institutional Biosafety Committee [IBC], etc.) to assess the operational feasibility and availability of clinical resources, research resources, and staff. The oversight committee meets twice a month and is required prior to any IRB submission.
Typically around 8-12 weeks’ time once all final versions of the necessary regulatory documents are received (this includes current protocol, IB, approved ICF templates, and study manuals for ancillary review).
Yes.
The CTA/Budget negotiation process typically takes anywhere from 6 to 8 weeks, depending on complexity, etc. However, the length of time is dependent on whether a CRO is involved, how long the sponsor takes to review site edits, and whether there are unique issues involved. Master agreements (MCTA) may be in place or considered when multiple trials are anticipated with the same sponsor.