Services
Health Authorities Submissions
Because the preparation to Health Authority submissions requires a specific work and expertise, BIOMETYL proposes a wide range of services to optimize your submissions and ensure the compliance to Health Authorities requirements and constraints:
- Requirements analysis
- Selection of Studies to submit : conversion feasibility evaluation
- Pool ISS / ISE and feasibility
- Data conformance evaluation vs CDISC SDTM
- Timelines and budget definition
- Service Provider selection
- Specific request for proposal creation
- Proposal review and expertise evaluation (Bid defense meetings)
- Service Provider oversight
- Review and validation of SDTM/ADaM deliverables
- Annotated CRF – SDTM database review (including reviewers’ guide, define.xml) for individual studies
- ADaMs review including Reviewer’s guide and define ADaM for individual studies
- For ISS and/or ISE : review of Pool SDTM, Pool ADaM and related reviewer’s guide and defines
- Submission package preparation
- For individual studies
- Pool ISS/ISE
