Mid-sized Pharma (contracting out some development activities)
Situation: SteadyDrug, a pharma company, has implemented Core DLPs and has a substantial library of specialty DLPs. It has a study upcoming for which it needs to contract out the data management, monitoring, and clinical study report writing, each to different vendors.
Implementation: They select the DLPs to cover all the protocol’s data and send the CRF, database and edit check sections to the data management vendor, the monitoring guidelines and CRF completion instructions to the monitoring vendor, and the CSR template and CSR section to the medical writer.
These documents, along with the protocol, allow SteadyDrug to be sure that the deliverables they receive from each vendor will have been produced based on consistent requirements and assumptions.