Representatives from ACI’s Data Standards Team attended the CDISC International Interchange in Chicago, IL, November 9-13, 2015. As a CDISC Registered Solutions Provider for over 10 years, ACI maintains comprehensive knowledge of CDISC Data Standards and the challenges sponsors typically face on the path to regulatory submission.
With the FDA’s deadline for sponsors to meet CDISC Standards by the end of 2016 fast approaching, the recent conference focused on standards implementation across the spectrum of healthcare and clinical research data applications.
Goals such as “Standards from the Start” can ensure a brighter and simpler future for New Drug Application (NDA) submissions. In today’s landscape, however, sponsors are typically faced with submitting multiple datasets that were collected long before these standards were recommended.
When seeking to file an NDA, sponsors routinely contend with datasets yielded from not only numerous studies conducted over many years but also from multiple vendors with their own data standards. All of this legacy data must be harmonized to create a cohesive FDA submission, which creates a complex challenge for sponsors as they approach the submission stage.
As an experienced data services provider and CDISC Registered Solutions Provider for over 10 years, ACI Clinical has assisted many clients with this pivotal step on the path to market. From database integrations for large multi-study programs across all phases of research, to meeting challenging timelines while collaborating with multiple vendors, ACI has successfully resolved complex data standardization issues for clients large and small.
One of our recent clients initially approached us requesting CDISC conversion services and NDA submission assistance with a timeline of less than one year. The sponsor had an ongoing Phase III trial which was scheduled to complete by the end of the year, and four completed legacy studies which required integration. Each legacy study had been conducted by a different vendor, each with unique data standards. To harmonize the data and meet FDA submission requirements, ACI converted and validated each dataset to meet CDISC standards.
ACI’s services included performance of legacy data conversions and creating an Integrated Summary of Safety (ISS) for the studies. After initial project work was underway, the client requested additional services for 12 Phase I studies. These significantly older studies required a custom-tailored solution to meet current FDA submission guidelines. ACI was able to review the aging, heterogeneous datasets and create a submission format which helped to harmonize this data where possible and flag any exceptions for clarity.
As an expert provider of data standards solutions for clinical research needs, ACI can meet your project needs within time and budget while you rest assured that your submission is compliant to the latest FDA requirements.