In order to help standardize clinical research data across the industry and expedite the drug approval process, the FDA mandated in 2016 that all clinical trial data for a drug program must be submitted to the FDA in CDISC data standard format. Therefore, it is highly important that sponsors establish a data plan to meet CDISC requirements ahead of a successful submission and it is often more cost-effective to begin this planning early in the development life cycle.
If CDISC conversion is completed incorrectly, it could risk the submission timelines to Regulatory Agencies. Incomplete SDTM or data quality issues in SDTM could also impact ADaM data, which would ultimately impact the ease with which the FDA can trace source data to reproduce the analysis results. If the data does not pass the published CDISC compliance checks and FDA’s data fitness tests, this can lead to a Refusal to File (RTF).
Ideally, data standards should be implemented early in clinical development; however since CDISC is a recent requirement, some sponsors are now facing many different challenges in converting data from legacy formats to CDISC accurately and on time. The difficulties often occur because the trial database was not initially designed with CDASH or SDTM standards and controlled terminology. Additionally, there is often inconsistencies in the data structure, domain assumptions, and data mapping across multiple studies within a single clinical program. Therefore, the sponsor must allocate a resource to retroactively analyze the data across all trials and convert the raw datasets to SDTM/ADaM standards. In doing so, they must create all the necessary documentation surrounding metadata and apply the appropriate value-level mapping during the generation and validation process. If there is both legacy data and non-legacy data, mapping can be difficult, especially when they are part of the same submission.
Many sponsors fully allocate their resources to the conduct and analysis of clinical trials and do not necessarily have a dedicated data standards team with enough resources to convert complex data just prior to regulatory submission. In companies that do not have the resources necessary, it would be advantageous for a client to outsource their CDISC conversion. Conversion services are also best outsourced if a company acquires a significant number of non-CDISC standard studies from another company and does not want the data conversion of those studies to affect their NDA filing critical timeline. ACI Clinical experienced staff can help eliminate challenges Sponsors face with CDISC conversion. Having completed conversions of hundreds of clinical trials across many therapeutic categories, we have completed all submissions successfully and on time with no Refusal to File issued for any of our submissions.
Contact us today at firstname.lastname@example.org or +1 (484) 429-7200 for additional information on ACI’s approach for managing CDISC conversion or to discuss how we might support any upcoming projects.