As the largest group within Bioforum and a CDISC Registered Solution Provider since 2009, we provide diversified SAS programming services tailored to customer needs.
Our clinical programmers have vast experience with many therapeutic areas and indication across different study phases and constantly keep up with current guidance and developments as they pertain to data standards and regulatory demands.
Bioforum’s team has created many Integrated Summaries to support our clients’ submissions over the years.
We have specialized in integrating legacy studies with recent studies to establish a unified and cohesive package.
Together with our statistical and medical writing team we can assist in planning the client’s data strategy to make sure the submission won’t be held by unexpected demands from regulatory entities.
- CDISC – SDTM, ADaM, SEND (pre-clinical), SDTM-MD (Medical Devices)
- Metadata – define.xml, SDRG and ADRG
- Legacy studies support –
- Gap analysis according to the latest regulation
- Prepare legacy package for submission
- Data conversion to CDISC standards
- Statistical analysis of clinical data
- As part of INDs, IDEs, NDAs, 510Ks, PMAs, ANDAs and BLAs
- Study Interim analysis
- Custom analysis per customer/regulatory agencies requirements
- Meta-analyses of multiple sources
- Tables, listings and figures (TLFs)
- Data integration and analysis for safety and efficacy summaries (e.g., ISS/ISE)
- Periodical and safety committees reports (e.g. DSUR, DMC)