Our customized clinical data management services, including EDC, Clinical Data Review, Coding, CDISC Conversation & Data Standardization enables complete utilization of the collected clinical data.
The complementary biostatistical services, including SAP Development, SAS Clinical Programming, Analysis, Submission-Ready Services and Statistical Reports are customized and designed specifically to meet the project requirements
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.
- 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)