Defining the Request for Proposal (RFPs) Process for Clinical Trials

March 23, 2021

A Request for Proposal, or RFP, is a document soliciting bids from different contractors or service providers. Often, RFPs take the form of very detailed questionnaires, outlining all the specific services or features that are necessary for a particular project.

When planning clinical trials, RFPs are often issued by sponsors who are about to start a clinical trial but want to outsource some or most of the project. Often, service providers – such as CROs – will also issue their own RFPs to find the ideal subcontractor. Because of this, CROs frequently find themselves on both sides of the RFP process.

For any proposals or bids to be useful, however, they need to be tailored to a well-developed RFP. A well-conducted RFP process will prepare the ground for successful study implementation.

Overview of the RFP Process

Usually, the entire process around RFPs for a clinical trial takes around 2 to 4 weeks. Despite the short time frame, it is a very labor-intensive task: during this time, the RFP should be disseminated among all potential vendors. Then, each company will need to elaborate a detailed response. Finally, the sponsor will need to select a winning proposal and request a quote.

Clinical research organizations not only respond to sponsor's RFPs, but often they will issue requests of their own to outsource supportive services or to procure local supplies. Because of this, they can offer insights on how to draft an RFP that will elicit good responses, and how to develop proposals that will meet the client’s explicit and hidden needs.

Making an Effective Request for Proposal

Party issuing an RFP should attach the study synopsis and the key parameters for the study, such as the size and length of the trial and their preferences in terms of regions and number of countries and sites involved. Other aspects to be considered include:

- Selecting RFP recipients

Whenever an RFP is issued, the buyer’s goal should be to receive a handful of detailed, comprehensive replies. It is best to send the request only to a few predefined or pre-screened service providers.

A large number of replies may sound like a good thing but often results in a large share of superficial proposals. This will also increase the time needed to sift through each item offered and evaluate it properly.

- Determining scope

Defining the scope of services requested from the start will, more likely than not, allow for shorter negotiations later in the process. Anyone receiving an RFP should be provided with the study documentation and the parameters of the study. This will allow them enough time to identify key bottlenecks or business preferences. 

Ensure the final reply deadline is reasonable: even if the projected starting date is near, it is best to provide bidders with enough time to send back an accurate and detailed proposal. 

- Allowing feedback

The RFP should leave room for comments or alternative paths. Service providers are usually experts in very specialized fields, and they may have valuable input on the study plan.

A “bid defense” step will ensure that the different bidders (or at least, those shortlisted) have a chance to present their bid in person or via video call. This will give both parties a chance to understand the dynamics and gain extra insight.

Making a Quality Proposal after Receiving an RFP

On the other side of the coin, the process to reply to an RFP requires exacting organization and coordination strategies.

Ideally, each service provider should already have an outlined proposal development process. This will identify the process drivers (people or teams) that will be responsible for each step or subfield. A list of established experts (medical or legal professionals, project managers, procurement specialists, or even financial advisors) should also be ready beforehand to gather any necessary information.

Proper coordination should include:

  1. Ensuring that any necessary NDAs, approvals, or signatures are ready from the moment an RFP is received.
  2. Distributing responsibilities and deadlines for each team member
  3. Providing a channel for mutual accountability, to request expert advice, or to share suggestions
  4. Performing a Risk Assessment study for each stage of the potential project.

A CRO with an established presence in a subspecialty is likely to have access to in-house knowledge that many sponsors wouldn’t. If a team member can offer an improvement on the study plan or protocol, they should share it with the Sponsor as part of the proposal or as an addendum to it.

When dealing with a full-scope RFP, CROs may need to outsource certain parts of the process as well (like logistics, laboratories, or central reader providers). This part of the process will be easier if the CRO has already established close relationships with such vendors. Organizing any past contracts or prior quotations, even if they didn’t win the bid, will help the CRO have a starting point of reference for these services. In turn, this will allow them to draft new proposals more quickly.

Key Takeaways

For both Sponsor and Service Provider, the key to a smooth RFP process lies in coordination and preparation. By having established processes and timelines from both sides, many of the time-consuming steps behind an RFP will be shortened. Opportunities for dialogue – from asking for clarification to a bid defense step – should be maintained throughout the process.

For Dokumeds, submitting a proposal is an opportunity to showcase the depth of our experience in clinical trial implementation. Our existing pool of vendors allows us to offer detailed proposals that directly address each Sponsor’s needs. Our in-house talent is often able to pre-empt future possible problems, improving the chances of a successful trial. Learn more about the clinical trial process by getting in touch with our specialist team today.

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