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5 Tips for Creating a Request for Proposal (RFP) for Clinical Trial Services

Posted by Jamie Hahn on Tue, Jun 05, 2012 @ 11:46 AM


tool for clinical trial servicesIf you’re looking for a contract research organization (CRO) to provide clinical trial services, chances are you’ll need to create a request for proposal (RFP). In the complicated world of outsourcing clinical trials, using RFPs to gather comparable bids from CROs can be incredibly challenging. The good news is, with a little planning and time, you can create RFPs that will reduce inconsistencies among bidders and ultimately help you identify the CRO that is truly the right partner for the job.

Here are five tips for creating RFPs that will help you compare “apples to apples” and help the CROs better understand your needs, values, and selection criteria for your clinical trial services:

1. Provide background info on your compound and program

2. Provide a protocol or protocol synopsis

3. Provide detailed RFP information to get consistent costs. Be specific. Some examples, might include:

  • Project specifications – What are the important details of your program? (Use our RFP specifications tool)
  • Project timelines – By when do you expect certain milestones to be met?
  • Responsibilities (CRO, sponsor, other vendors) – For which segments of your program do you need a CRO to provide clinical trial services?

4. Provide additional details. The more details you can provide the better.  It’s also OK to ask the CRO to make recommendations. You can tell a lot about a CRO by the recommendations they make and how they make them.  However, if you ask CROs to make recommendations be prepared for potential inconsistencies in the assumptions made and pricing offered between different CROs. The following are some additional details that might be helpful to bidders:

  • Paper or EDC?
  • Data output in CDISC format?
  • Provide site locations
  • Central or local labs?
  • Additional vendors (specialty labs, IRBs, translations, etc)?
  • Interim analyses, DSMBs, etc?
  • Automated subject randomization and clinical trial material re-ordering and shipping?

If you know you want to use certain specific vendors (i.e. you know you want to use Medidata RAVE for EDC), be sure to include that information.

5. Other items to request from CROs:

  • Project team CVs
  • Summary of team therapeutic experience and experience running similar trials
  • Relevant company information

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