How to Create an RFP for Bioanalytical CRO Services

Selecting a bioanalytical CRO is an important decision in drug development, but the process begins well before proposals arrive. A well-structured request for proposal (RFP) gives a CRO the scientific and operational context they need to develop an accurate proposal.

You may know what you need the data to accomplish, without knowing exactly what information a bioanalytical CRO needs to develop a scope, recommend an analytical strategy, estimate costs, or establish a realistic timeline. You do not need to have every scientific or operational detail finalized; however, the more clearly you communicate your program, objectives, sample characteristics, timelines, and expectations, the more useful and comparable the CRO responses will be.

What should be included in a bioanalytical CRO RFP?

At a minimum, a bioanalytical RFP should provide information about the development program, therapeutic modality, bioanalytical objectives, sample details, assay requirements, expected services needed, regulatory and quality expectations, timelines, project management expectations, and pricing.

The level of detail should be appropriate to the stage and complexity of the program, with enough information for a CRO to scope the work without unnecessarily restricting their scientific approach.

The table below provides a practical starting point.

RFP Area	What to provide	If you don’t know yet
Program	Development phase, study type, objectives, key milestones	Provide the current development plan and identify preliminary information
Therapeutic	Modality, relevant drug characteristics, metabolites or other required analytes	Provide what is known and flag information still being generated
Bioanalytical objectives	What you need the data to tell you	Describe the scientific question rather than trying to define the assay
Samples	Matrix, species, approximate sample count and volume, shipping schedule	Give an estimated range and explain your assumptions
Assay strategy	Required performance, information on any existing methods, and/or preferred technology	Ask the CRO to recommend an appropriate approach
Development and validation	Development, qualification, validation, transfer, and sample analysis expectations	Describe the current method state and intended use of the data
Quality and regulatory	applicable regulations (ex. GLP/GCLP), submission plans, and data expectations	Identify the planned regulatory region and ask the CRO to identify relevant considerations
Timeline	Sample availability, study milestones, and data delivery dates	Provide target dates and ask the CRO to identify dependencies
Project management	Communication, reporting, and team expectations	Ask the CRO to describe its proposed management model
Pricing	Requested cost structure and assumptions	Ask the CRO to identify assumptions and potential variable costs

The goal is not to fill in every box perfectly. The goal is to give the CRO enough context to understand what you are trying to accomplish and where additional discussion may be needed.

Start with the development program

Begin your RFP by explaining the broader context of the work. A CRO can develop a much more useful proposal when it understands where the bioanalytical work fits within the overall drug development program.

Include information such as:

• Development phase and study type
• Therapeutic modality
• Primary objectives of the study
• Planned regulatory submissions or development milestones
• Key dates that could affect bioanalytical work
• Other studies or activities that may influence the scope

For example, an assay supporting an early preclinical study may have different requirements from an assay generating data intended to support a regulatory submission. You do not need to provide your entire development plan. Focus on the information that could affect the bioanalytical strategy, scope, timing, or interpretation of the data.

Explain what you need the bioanalytical data to tell you

One of the most important parts of an RFP is also one that sponsors sometimes overcomplicate: explaining the scientific objective. Rather than trying to specify exactly how the CRO should perform the analysis, start by explaining what you need to learn from the data.

For example, you may need to:

• Characterize exposure or pharmacokinetics
• Quantify a therapeutic or metabolite
• Assess biomarkers or pharmacodynamic endpoints
• Measure anti-drug antibodies or neutralizing antibodies
• Support immunogenicity assessment
• Quantify analytes in a particular biological matrix
• Generate data for a regulatory submission

This distinction is particularly important when you are not sure which analytical technology or methodology is most appropriate. A strong RFP communicates the scientific question while giving the CRO enough information to recommend an appropriate analytical strategy.

Describe your samples

Sample information directly affects the scope, feasibility, capacity, and cost of bioanalytical work.

Provide as much of the following information as is available:

• Species and biological matrix
• Approximate number of samples
• Expected sample volume
• Sample concentration range, if known
• Collection and storage conditions
• Expected sample availability date
• Any special handling requirements
• Whether samples will arrive in one shipment or multiple shipments

If the final number of samples is not available, do not wait until every detail is finalized before engaging potential CROs. An estimated range can still be useful. For example, stating that the study is expected to generate approximately 500 to 700 plasma samples gives a CRO more information than simply stating that sample analysis will be required.

The important point is to make your assumptions visible so the CRO can account for them when developing its proposal.

Know how prescriptive to be about the assay strategy

Sponsors sometimes assume that an RFP needs to specify the exact analytical technology they want. In many cases, it does not.

For example, a sponsor may know that a ligand-binding assay is appropriate for a particular large molecule program. In another situation, the sponsor may be better served by describing requirements such as sensitivity, specificity, dynamic range, throughput, and sample matrix, then asking the CRO to recommend the analytical platform.

This distinction gives the CRO an opportunity to contribute scientific expertise rather than simply confirming that it can execute a predetermined method. A strong RFP can therefore ask not only, “Can you perform this assay?” but also, “What approach do you recommend, and why?”

If you know…	Consider asking the CRO to…
The exact analytical technology required	Confirm the approach, requirements, and execution plan
The analytical performance you need but not the technology	Recommend an appropriate platform and methodology
The scientific objective but not the assay requirements	Propose an analytical strategy based on the objective
An existing method is available	Evaluate the method and recommend development, optimization, transfer, or validation needs
The study design but not final sample numbers	Scope the work using an estimated range and identify pricing assumptions

This is especially relevant for emerging biotech companies that may have strong scientific expertise but limited internal experience outsourcing bioanalysis.

Define the expected bioanalytical services

Be clear about which activities you expect the CRO to perform. Depending on the program, this could include assay development, optimization, qualification, validation, sample analysis, method transfer, data analysis, and reporting.

Include quality and regulatory expectations

Quality requirements should be explicit rather than assumed. Depending on the program, this may include requirements related to:

• GLP or other applicable quality standards
• Purpose of the data generated
• Regulatory submission plans
• Geographic or regulatory requirements
• Bioanalytical method validation
• Study sample analysis
• Electronic data or reporting requirements

If you know which regulatory agencies or regions the data are intended to support, include that information.  If you are uncertain about which requirements apply, say so. A qualified bioanalytical CRO should be able to identify relevant considerations and explain how they affect the proposed work.

Give the CRO a realistic timeline

A requested completion date is useful, but it is not enough on its own. Provide the key milestones that drive the bioanalytical program, such as anticipated sample availability, study initiation, data delivery, and regulatory submission dates. Then ask the CRO to provide its proposed timeline and identify assumptions or dependencies that could affect it.

This turns the timeline into a scientific and operational discussion rather than a date that simply appears on a proposal. It also gives the sponsor an opportunity to identify potential schedule risks before work begins.

Explain how you want the program managed and what their relevant experience is

Project management can have a significant effect on the sponsor experience, particularly for programs involving multiple assays, studies, sites, or development milestones.

For complex programs, sponsors may also want to understand how scientific issues are escalated, how communication is managed, and how continuity is maintained throughout the study. You can also ask for examples of how the CRO has addressed challenges similar to those anticipated in your program.

The goal is to understand whether the CRO has relevant scientific experience and can anticipate issues that may affect your study.

Make pricing transparent

Price is an important component of an RFP, but a single project total rarely tells the full story. If you know the format you want, specify it. For example, you may want separate pricing for assay development, validation, sample analysis, additional experiments, or other potential activities.

The objective is not simply to identify the lowest number. It is to understand what each proposal includes and what assumptions are driving the estimate.

What if you don’t know everything before sending the RFP?

You probably won’t. For many programs, some information will continue to evolve while the RFP is being prepared. Sample numbers may change. Study timelines may shift. An assay may still be in development. Regulatory plans may not yet be finalized.

That does not necessarily mean the RFP needs to wait. Instead, distinguish between known requirements, reasonable estimates, and open questions.

A practical bioanalytical CRO RFP checklist

Before sending your RFP, make sure you have addressed the fundamentals:

• Program: What are you developing, and where are you in development?
• Objective: What do you need the bioanalytical data to tell you?
• Samples: What matrix, species, volume, and approximate sample numbers are involved?
• Assay: Is there an existing method, defined performance requirement, or open question about analytical strategy?
• Scope: Which development, validation, transfer, and sample analysis activities are needed?
• Quality: What regulatory, quality, and reporting requirements apply?
• Timeline: When will materials and samples be available, and when are results needed?
• Management: How do you expect the program to be managed and communicated?
• Experience: What relevant experience should the CRO demonstrate?
• Pricing: How do you want the CRO to structure and explain its costs?

If you can answer these questions, you have a strong foundation for an effective RFP. If you cannot answer all of them, identify what is known and ask the CRO to help address the remaining questions.

How KCAS Bio supports sponsors during the bioanalytical CRO RFP process

KCAS Bio works closely with sponsors to understand the scientific, regulatory, and operational objectives behind each program before proposing a bioanalytical strategy. Rather than taking a one-size-fits-all approach, our teams evaluate factors such as molecule modality, assay complexity, regulatory milestones, sample volume projections, and study timelines to develop a solution aligned with the program’s needs.

Whether supporting pharmacokinetic (PK) assays, immunogenicity testing, biomarkers, cell and gene therapy programs, or other complex bioanalytical requirements, KCAS partners with sponsors throughout the project lifecycle, from study planning and method development through validation, sample analysis, and reporting. Our goal is to provide the scientific expertise, quality systems, and project management support needed to help sponsors generate reliable data and make confident development decisions.

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