A biotech client approached Veramed through a consultancy engagement with a unique challenge: to convert legacy clinical trial data dating back to 2011 into modern CDISC-compliant formats for regulatory submission and potential reuse in future studies. This comprehensive task involved the full CDISC package: SDTM and ADaM datasets, along with the creation of essential components such as the define.xml, reviewers guide, annotated CRF (aCRF), and a legacy data conversion plan.
Spanning approximately six months, the work showcased Veramed’s adaptability, deep technical expertise, and collaborative approach. The effort stands as a testament to Veramed’s ability to deliver high-quality, regulatory-ready outputs under complex and evolving circumstances.
The issue
The client faced several challenges: they had extremely outdated datasets from 2011, with no access to the original study staff. Additionally, the documentation was incomplete, and some external data was missing. They needed to replicate the original analysis results using modern standards. The goal was to convert this data into current CDISC formats and validate the outputs against the original results, despite the lack of institutional memory and consistent data sources.
The solution
Veramed’s team, led by seasoned programmers, approached the project with a meticulous and investigative mindset. They embarked on a data forensics mission, identifying and reconstructing missing data using available CRFs, SDTM equivalents, and scanned PDFs converted to Excel. The team then modernised the data by applying current CDISC standards while preserving the integrity of the original information.
Rigorous validation followed, with meticulous comparisons between legacy outputs, ensuring every discrepancy was identified, explained, and documented. Throughout the process, Veramed maintained open communication with the client, despite the limited access to original stakeholders.
The outcome
The outcome was a resounding success. Veramed converted and validated three complex legacy studies, delivering high-quality outputs on time and under budget. The team’s meticulous approach and technical excellence not only impressed the client but also led to a follow-up engagement: a rescue study for a live Phase II extension. The exceptional quality of Veramed’s work left a lasting impression, prompting the client’s lead statistician to recommend Veramed to a new organisation, resulting in a verbal award for future collaboration.
“To reiterate we were very happy with the quality of these outputs, the implementation of the reporting groups and the attention to detail on the review to highlight issues to the team.”
Client Lead Stat
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