Biomarker/ BioBank Operations
Case: Need to consolidate Biobank operational data into a reportable structure, with no commercially available software to meet needs
Biomarker studies add a level of complexity to clinical trials that is often beyond the scope of a standard clinical trial. Most clinical trial software is not robust enough to manage these complexities. Additionally, many companies are creating a new function, Biomarker Operations, to manage the complex biomarker studies within a clinical trial. Often different operational groups (ex: PK, biomarker, imaging) may manage different components of the trial it is imperative that the existing operational IT tools can talk to each other to
Below are some impactful uses for the Metrendalytics biomarker application.
- Capture specimen collection timepoints
- Track volume of samples, aliquots and blocks/slides collected
- Sample collection tube type or tissue preserving methods (critical for downstream biomarker use)
- Define assay requirements for biofluids and tissue
- Forecast samples to be stored in a biobank
- Track sample use limitations/permissions
- De fine sample flow for testing (example: site, central lab, analyzing lab and biobank)
- Initiate RFP’s with biomarker vendors/labs (internally and externally).
- Measure vendor response time to RFP’s
- Link to executed agreements and budgets for biomarker work
- Generate reports to measure/quantify the success of a biomarker study
- Define biomarker data reporting timelines and transfers
- Track country/site level ICF informed consent permissions
