The life sciences industry thrives on innovation that often hinges on efficient and effective research. Outsourcing research tasks—or even complete programs—to specialized organizations, such as contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) can be a strategic decision. Navigating this process effectively requires a well-defined roadmap. A crucial element of this roadmap is a comprehensive and actionable request for proposal (RFP). According to industry experts, a common criticism of RFPs submitted by program sponsors is that they are unclear, lengthy, and have unrealistic timelines or budgets. This makes it difficult for CROs and CDMOs to understand the project and develop competitive bids. Another issue is that RFPs may lack important information or be overly focused on price, which could discourage high quality, comprehensive proposals.
To help you avoid these common pitfalls, we outline the key components of an effective RFP specifically tailored for outsourcing life sciences R&D, clinical trials, and manufacturing projects. Following these guidelines should help you ensure clear communication of your needs, attract the best outsourcing partners in a timely manner, and lay the foundation for a successful collaboration.
A comprehensive RFP acts as a blueprint for potential partners, allowing them to understand your project thoroughly and tailor their proposals accordingly. Starting with a well-structured document also allows bidders to deliver consistent proposals that are easier to compare. Here are the key requirements for a great RFP:
Clearly define your research objectives and deliverables: State the specific research problem you are trying to solve or the question you are aiming to answer. Breaking down your research goals into smaller, measurable objectives helps prospective partners grasp the scope of work and tailor their proposals to address them effectively. Consider including your company’s overall corporate objectives. For example, if you are aiming to generate proof-of-concept data for a seed funding round. Identifying these value inflection points helps partners understand the bigger picture and provide input on how to reach those objectives in a capital-efficient way.
Where possible, define how you will measure the success of the program. This can be tricky because discovery programs are often exploratory and most CROs operate under a fee-for-service model, and not success/risk-based. However, outlining your approach demonstrates a commitment to rigorous data collection and analysis.
Provide detailed information regarding research scope and deliverables: The more information you provide, the better potential partners can understand your needs and tailor their approaches. Be sure to be specific about your program, including therapeutic area (if applicable), preferred methodologies, timeline for starting the project and desired completion date, biosafety level requirements, and desired data deliverables. When detailing methods, differentiate between essential methods (e.g., trying to reproduce data or replicating a published method) and areas where you’re open to suggestions on how to achieve your research objectives.
Include regulatory considerations: Outline specific compliance requirements you have, such as Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), or Good Clinical Practice (GCP), typically referred to as GxP. And, importantly, specify required documentation or the need for third-party audits.
Provide context and background information: Relevant data, such as details about formulations and existing studies, reports, or publications can help inform the research approach. Ensure these are included in the RFP. Sharing this information upfront prevents vendors from having to guess or make assumptions and, potentially, make mistakes. Be upfront with your internal expertise. This transparency also helps to avoid duplication of effort. If your organization has unique capabilities relevant to the project, outline those. But remember to weigh the cost advantages, if any, and possible time disadvantages of conducting specific parts of the project in-house versus outsourcing the entire program.
Include your budget expectations: While avoiding rigid constraints, provide a general range to guide prospective partners in their proposal preparation. Over budgeting is generally recommended to account for unforeseen circumstances.
Share your expectations for program governance: Include information about level of engagement and governance; e.g., if there will be a single point of contact or a steering committee managing the project. Ensure that the level of engagement is fit for the stage of the program. You likely don’t need a steering committee to manage a plasmid production project or a simple animal-dosing study. However, outsourcing a complete program from target identification to investigational new drug (IND) or scaling a manufacturing process to commercialization with a partner organization will likely require guidance and oversight by suitable expert teams on both sides.
Disclose your evaluation criteria and selection process: It is important to define your priorities for selecting a partner, outline the evaluation process, and establish a decision-making timeline. Clearly state your top two priorities between following:
While most discovery stage projects don’t require strict regulatory compliance, clarify any specific requirements you may have.
Ensure confidentiality: Do not include confidential information in an RFP. It is typically not necessary to disclose such details, e.g., the specific target or the structure/sequence of a test compound. Once you have reviewed submitted proposals, you should implement a confidential disclosure agreement (CDA) with vendors with whom you would like to enter into in-depth discussion to allow for an open and constructive discussion. Note that CROs typically require a CDA to provide binding pricing for more complex projects. In general, establish clear procedures for protecting sensitive information shared by potential partners during the RFP process. This helps to build mutual trust—prospective vendors need to be assured they can trust you.
Be concise. Avoid information overload. Present a well-organized document that is easy for vendors to navigate.
Use clear language. Avoid infrequently used acronyms and technical jargon specific to your organization that prospective partners might not understand.
Set realistic deadlines. Provide ample time for potential partners to prepare comprehensive proposals. Consider offering guidance, such as five days for a simple assay or in vivo project, and two weeks for complex programs.
Communicate effectively. Be responsive to questions and clarifications throughout the process. For programs with interdependencies between components, a brief call is more efficient. After review of proposals, consider hosting a 30-minute call with each vendor under consideration to address any questions.
Create a scorecard. Having an internal scorecard ready before proposals start coming in can be invaluable for ensuring an objective assessment of the information provided.
Typical scoring criteria might look like this:
| Attribute | Points |
|---|---|
| Expertise and experience Evaluation to include evidence of past performance of required services, quality of work, and references |
30 |
| Cost | 15 |
| Lead time | 20 |
| Turnaround time Evaluation to include documentation of turnaround times for projects of comparable scope |
20 |
| Regulatory compliance Evidence of a strong record of positive regulatory audits is required |
15 |
| Total | 100 |