As part of the FDA Study Data Technical Conformance Guide, the agency is mandating the use of the CDISC standards as part of preparing clinical and nonclinical data for submission. By the end of 2016 studies that will not follow the CDISC Standards will not be accepted by the FDA.
Bioforum is a Registered CDISC Solutions Provider and our experts have in-depth understanding of clinical data standards and requirements. Starting with data collection using CDASH, to submission using SDTM and analysis using ADaM, we are highly experienced in supporting any data conversion and standardization needs.
By considering the complete clinical data lifecycle we are able to apply best practices in the early planning and design of the trial, implementing the most suitable and efficient Submission Ready approach.
Bioforum has been preparing clinical study data for submissions using the CDISC standards for over 7 years, converting and reviewing over 200 studies to date, both ongoing and legacy data.
Our CDISC services include:
- CDISC SDTM / ADaM Implementation Consulting
- CDISC SDTM / ADaM Data Conversions