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Make sure you have a firm deadline - PharmaFacts
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Make sure you have a firm deadline

Deadline



Be very clear about timeline requirements and the final delivery date for the fully audited signed report. Work back from that date setting milestones for all of the interim deliverables.

There are several operative factors that can impact timelines.

 

  • CROs have internal timelines governed by
    • how long it takes for the process
    • other customers competing for the same study slots and resources
  • Sponsors have their own internal timelines
    • availability of drug substance
    • document review by project team members
    • management input and sign-off

A competent CRO will be accommodating in providing milestones and agreeing to go/no-go decision points. These can be incorporated into the intial bid summary document and will factor for things such as:

  • Preparation for the actual start of study
    • Ordering supplies
    • Room availability
    • Technical resource availability and any necessary training
    • Equipment set-up
    • Animal care and use committee approval
    • Animal ordering, receipt, and acclimation
  • Study start date
  • Data processing and analysis
    • Intermediate data, tables, and figures
  • Unaudited draft report
  • Report review
    • These may go through several iterations and can be a significant source of delay in the completion of the study. It is a very good idea to have a point person to keep on top of this stage to ensure prompt review and return to CRO

Plan carefully in the initial stages and monitor timelines and milestones. This will ensure timely delivery of final report. An additional bonus is that careful planning will facilitate efficient management of any deviations that occur in the process.