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

Posted by Brook White on Tue, Feb 14, 2017 @ 11:13 AM

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RFPs tips that allow apples to apples comparisons of 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 information on your compound and program.  Information about other clinical studies completed or in progress, outcomes from preclinical work, regulatory strategy and even funding and marketing plans can provide context that will help a CRO understand your needs and give you a proposal that best addresses all of your concerns.
  2. Provide a protocol or protocol synopsis.  Details about the study, such as number of clinical trial sites, number of subjects, and type and frequency of procedures and assessments are important cost drivers and providing them will help ensure a more accurate proposal.  Also, an experienced CRO should also be able to make valuable recommendations based on your protocol.
  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 questions of prospective CROsask 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:
    • Provide site locations if you have already determined which sites you want to use.  If you aren’t sure, ask for recommendations based on your target enrollment and timelines.
    • If you’ve already determined which sites you’ll be using, it is helpful to know whether they will use a central lab or local lab and also will they use a local or central IRB. This can have an impact on timelines and costs.
    • Make note of any additional vendors you need such as specialty labs, Electronic Patient Reported Outcomes (ePRO), translations, meeting planners, or imaging services.
    • Will you be using paper or EDC? The vast majority of trials are now using EDC, but there may be some small studies or specific circumstances where paper still makes sense.
    • Do you want your data output in CDISC format? Based on the FDA’s guidance, new studies must be submitted in CDISC format, so it is strongly recommended.
    • If you are planning an interim analyses or will need support for a DSMB, make sure to include this information.
    • Will you use automated subject randomization (IVRS or IWRS)?
    • What are your plans for clinical supplies and distribution (IP management)?
    • Are you interested in risk-based monitoring strategies?  If so, include this information in your RFP. Incorporating remote monitoring or targeted SDV strategies could impact the budget.What are your plans for clinical supplies and distribution (IP management)?
    • Do you want the CRO to be responsible for the TMF?  If so, ask about whether they use an eTMF and if so which one.
    • If you know you want to use 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 including the project manager, lead CRA, lead data manager, medical monitor, and lead statistician
    • Summary of team therapeutic experience and experience running similar trials
    • Relevant company information
Download: RFP Specifications Tool