What a preclinical CRO needs in your RFP to quote it right the first time

I read RFPs from the CRO side every week. The ones that turn into fast, comparable quotes have one thing in common: the CRO doesn't have to guess. Every assumption a CRO makes on your behalf becomes a line item that differs from the next CRO's quote, and a revision cycle you pay for in time.

Here is what a quote-ready request covers.

1. The decision the study supports

Start with one sentence: what decision will this study inform? "Select a dose range for the 28-day GLP study" leads to a different design than "show efficacy for a financing round." When the CRO knows the decision, its study director can suggest a design that answers it, instead of pricing exactly what you wrote down.

2. The test article

Modality, formulation, vehicle, stability data, how much material you can supply, and when. Quantity matters more than most teams expect. Dose levels, animal numbers and study length together set how much compound the study consumes, and a shortfall discovered at dosing delays everything after it.

3. Test system and group design

Species and strain, sex, age or weight at the start, the number of groups, animals per group, and any recovery or satellite groups. If you don't know the right numbers, say so and ask the CRO to propose them. That beats leaving the field blank, because a blank gets filled with an assumption.

4. Dosing

Route, frequency, duration, dose levels and dose volumes. For anything beyond a simple oral or IV dose, describe the procedure. Surgical implantation, intratracheal dosing and topical application under occlusion each change staffing and price.

5. Endpoints and sampling

List every endpoint: clinical observations, body weights, food consumption, clinical pathology, blood collection timepoints and volumes, terminal tissues and histopathology. For each sample, say where it goes: analyzed by the CRO, shipped to your lab, or stored.

6. Bioanalysis

Do you have a validated method, a qualified one, or none? Method development and validation can cost more than sample analysis and take longer than the in-life phase. State the matrix, the analyte, the expected concentration range and the number of samples.

7. Compliance and reporting

GLP or non-GLP, and whether you need a QA-audited report. Draft and final report timing, raw data format, and who archives what. GLP status changes staffing, documentation and archiving, so it changes the price.

8. Timeline and constraints

When must dosing start, and what drives that date? A fixed date, such as a pre-IND meeting or a board meeting, helps the CRO tell you early whether it has capacity.

9. How you'll compare the quotes

Ask every CRO to break out the same items: study conduct, animals, housing, subcontracted work such as clinical pathology, histopathology and bioanalysis, reporting, and anything excluded. Ask whether pass-through costs carry a markup. Then the totals mean the same thing from quote to quote.

The short version

A good RFP removes guesswork. The more a CRO has to assume, the more its quote reflects its own assumptions rather than your study.