How we work
A clear question.
A useful next step.
A structured consulting engagement with an agreed scope, explicit assumptions and a defined scientific output.
01 / Frame the engagement
Define the decision.
Start with the modality, development stage, sample and analytical question. Agree the intended use of the advice, available inputs, responsibilities and deliverable before substantive work begins.
A nonconfidential outline is sufficient for an initial discussion. Confidential documents follow an agreed exchange arrangement.
02 / Assess the evidence
Separate data from assumptions.
Review the method rationale, controls, sample handling and interpretation. Identify what the available evidence supports, what remains uncertain and what could change the next decision.
Where several methods address the same attribute, assess their assumptions and sources of disagreement.
03 / Design the next study
Make the plan testable.
Develop a proposed assay architecture or study plan with relevant controls, prospective criteria and decision logic. Select orthogonal measurements where one readout cannot resolve the question.
Distinguish development, qualification, validation and transfer requirements for the intended purpose.
04 / Translate the result
Deliver a reviewable output.
Provide a roadmap, technical assessment or method-development package with assumptions, evidence gaps and recommended next steps. Agree who owns laboratory execution and subsequent decisions.
Any additional work is scoped explicitly; an advisory document is not a certificate of method performance.
Frameworks, applied in context.
ICH Q14 and Q2(R2) can inform analytical development and validation thinking. Their relevance and the evidence required depend on the procedure, product, intended use, stage and regulatory context. They are not a company certification.
Start with the question
Complex therapies.
Clearer analytical decisions.
Define the scientific question behind your project. We can discuss the evidence, methods and practical next steps.
Scientific enquiries
Let’s talk about your project.
A brief, nonconfidential outline is a useful starting point.
contact@genometrion.comEmail GenometrionOpens your email application. Contact details and enquiry guidance.