Project management
Services
Project management
At BIOMETYL, we know this is critical for the client to ensure the quality and reliability of study data to obtain the most accurate analysis and maximize the chance of success.
We also know that, sometimes, this is difficult to have in-house expertise or ressources to ensure those expectations are met.
For this reason, we propose a full range of project management services for the Data Management of your studies - We are able to cover all steps of a clinical study from a DM perspective:
- Protocol review
- Service provider selection
- Tool selection (eCRF, ePRO)
- Planning and timelines definition
- Mock-up CRF creation / CRF design validation
- Service provider oversight / coordination (for outsourced activities)
- Cross-functional coordination with other stakeholders (i.e. statisticians, medical team, clinical operations, etc.)
- Deliverables review and validation (eCRF, Data Management Plan, Data Validation Plan, database structure, database migration/mapping, Data Review Plan, etc.) up to database lock
- TFLs and CSR review
NB: All these steps can be taken independently of the others according to your needs.
