Preclinical CRO Checklist: 12 Questions Before Signing

ByNouman

Most capability decks are interchangeable. Every lab lists DMPK, histology, and bioanalysis. Every lab says quality runs through everything it does.

The difference shows up in what a lab can put in writing within a day. You’re not buying a service here. You’re buying a data package that a regulator, a licensee, or an acquirer will read years from now, without you in the room to explain it. Before you sign with a preclinical UK CRO, these twelve questions expose the gap between the claim and the evidence.

Credentials: prove them, don’t take them

  1. Are you on the published GLP list, and under which facility name? The MHRA publishes a current list of full members of the UK GLP compliance monitoring program. Check that the address on the list matches the site your samples are going to. Brand names and legal entities don’t always line up.
  2. When was your last inspection, and what came out of it? UK GLP facilities sit on a cycle of roughly twelve to thirty months. You want the date, the scope, and whether anything was classified as critical or major. Vagueness is the tell, not the findings.
  3. Who is the named Study Director? Ask for a person, a CV, and how many studies they’re running right now. Twelve is a lot. Three is comfortable.
  4. Will my data travel? Under the OECD Mutual Acceptance of Data system, a GLP study run in one adhering country must be accepted in over 40 others. Ask whether the specific facility is covered. AAALAC accreditation, re-evaluated every three years, answers the animal welfare half of the same diligence question.

The work: who actually touches your compound

  1. Which parts stay in-house? Subcontracting is normal. Hidden subcontracting is how eleven weeks of tox work gets repeated. Get the breakdown in writing.
  2. Is the method already validated for my matrix? Not “can you run LC-MS/MS.” Ask whether a validated method exists today for your analyte, at your concentration range, and what happens if your compound proves unstable in plasma.
  3. What historical control data do you hold? A lab that can show its baseline variability for your model has run it enough times to know its own noise floor. Thin data isn’t disqualifying, but plan a larger n.
  4. Show me a redacted report from a similar study? Then read it the way a reviewer would. The ARRIVE guidelines 2.0 set out an “Essential 10” of reporting items. You want those already present, uncited.

The questions almost nobody asks

  1. What triggers a change order? Ask for three real examples from the past year. Not the policy.
  2. What format does my data arrive in? A PDF report is not a dataset. Agree the deliverable format before contracting, or pay twice for data you already own.
  3. Where does my raw data live, and for how long? Ask who the archivist is, what the retention period is, and what happens to your archive if the site closes or changes hands.
  4. What happens when a study fails? Not if. Animals die outside protocol, assays drift, formulations crash out. The right answer usually starts with a specific story. The wrong one is a reassurance that it’s rare.

If you only get to ask one

Every other answer is a claim about the lab. The report is the lab’s actual output, and compliance discipline and statistical honesty both show up inside it. Put two labs’ reports side by side, and the decision tends to make itself.

Before you sign

Write down the answers, then note which came back with documents attached and which came back with adjectives. That first column is your shortlist. A serious preclinical UK CRO will hand over most of this before you think to ask.

Similar Posts