Regulated bioanalysis is an important part of pharmaceutical programs at all stages, from preclinical to late phase development. Drugs, metabolites and biomarkers are selectively quantified by analyzing samples derived from blood draws (plasma/serum), urine or tissue collection. The resulting concentration data are input for the important PK/PD and safety determinations. (Bio)analytical methods to be used for these analyzes must be developed, transferred, qualified and/or validated according to strict global guidelines issued by, amongst others, FDA (Food and Drug Administration) and EMA (European Medical Agency). Part of pre-clinical development should be performed as GLP (Good Laboratory Practice)-regulated studies and generally the principles of this regulation will be followed in the clinical stages where GCP (Good Clinical Practice) is also important.
How can we help you with bioanalysis?
If you have no bioanalytical capacity and/or expertise in-house, Progress can support your bioanalytical needs with.
- Finding the right partner for your bioanalytical projects by selecting, auditing and contracting a CRO (clinical research organization).
- Project management services for outsourcing your study and subsequent tasks such as coordination with the clinics, data management and logistics providers.
- Fulfilling interim positions such as GLP Study Director or Principal Investigator.
- Prepare and review documentation, including study plans and reports, method validation reports and work instructions, data transfer and logistical agreements, clinical protocols etc.
For existing bioanalytical packages, we can perform a gap analysis before submitting your file to regulatory agencies. If you are facing an audit or inspection by a regulatory body, we can help you prepare for this by performing an audit readiness check and/or a mock audit. Moreover, we can support you in responding to information requests or audit findings.
Progress specialists can also offer support for your own bioanalytical laboratory or experts in house. If you want to design and build your own bioanalytical lab, set-up or update your QMS for bioanalysis or prepare for GLP certification, we are here to help you.