Clinical Data Transformation with a Lifesaving Impact

DLH was recently asked by a global pharmaceutical company specializing in the treatment of rare diseases to convert Phase II clinical trial data into FDA-ready, CDISC-compliant data sets. Our team was retained to ensure strict accuracy, consistency, and adherence to industry-leading standards throughout the process. The engagement involved mapping and standardizing hundreds of clinical and operational measures across Study Data Tabulation Model (SDTM) domains, as well as performing comprehensive data validation, quality control, and documentation to support regulatory submission requirements.

In parallel, DLH implemented a fully secure, auditable data pipeline within Infinibyte®– its FedRAMP-certified cloud environment, enabling traceability, data integrity, and compliance with federal security standards.

The partnership resulted in a successful submission. This end-to-end approach ensured the client’s data was not only submission-ready, but also structured to withstand rigorous regulatory review and support timely advancement of potentially lifesaving therapies to market. The FDA accepted the Investigational New Drug (IND) application without issuing further inquiries or requests for additional data, demonstrating the completeness and regulatory readiness of DLH’s work.

Background

DLH was engaged by a global pharmaceutical company to provide expert support in preparing an IND submission to the Food and Drug Administration.

The customer focuses on therapeutic areas related to rare and complex diseases. Through advanced research and development initiatives, it has positioned itself as a leader in providing critical care medications, with a commitment to improving outcomes for patients with limited treatment options. One of its flagship products is sodium thiosulfate (STS), a compound with a well-established safety profile and a diverse range of clinical applications.

The project’s core objective was to transform and standardize data from a Phase 2 clinical trial conducted by NIEHS, while ensuring full compliance with industry-leading Clinical Data Interchange Standards Consortium (CDSIC) standards.

Quality data is essential for FDA success. High-quality, standardized data enables faster, clearer, regulatory reviews and reduces the chance of costly delays or requests for clarification. Annotated datasets and documentation allow the FDA to easily trace findings back to the source, reinforcing transparency and confidence in the result, while thorough validation with industry tools and standards reduces the likelihood of submission issues and supports a successful regulatory outcome.

Data Transformation

DLH’s clinical data managers and biostatisticians brought deep, specialized expertise to every phase of the project—from initial data collection through final regulatory submission.

The team meticulously mapped variables to the appropriate domains and datasets, applying CDISC standards to ensure consistency in structure, content, naming conventions, formatting, and value coding. This disciplined, detail-oriented approach helped ensure the data met the highest expectations for quality, transparency, and regulatory compliance. To support secure storage and advanced analysis, DLH deployed dedicated virtual machines within a highly controlled, auditable data environment. This infrastructure not only safeguarded sensitive clinical data but also enabled full traceability and reproducibility—providing clients and regulators alike with confidence in the integrity of the results and the readiness of the data for submission and review.

DLH served as a trusted data steward, managing and analyzing reams of data, while maintaining a strict data firewall which ensured that data for the government contract was never used for client FDA work, and vice versa. With a rigorous commitment to quality and compliance, the DLH team thoroughly evaluated every dataset, table, listing, and figure, applying quality controls to guarantee data integrity and full traceability for regulators.

The Results

DLH delivered a comprehensive suite of submission materials—including annotated CRFs, SDTM and ADaM datasets, tables, listing, and figures statistical analyses, and detailed reviewer guides—carefully packaged for seamless FDA navigation and review. The submission was a success. FDA accepted the IND without further inquiry, allowing the customer to proceed to market with the emerging, promising uses for STS.

DLH’s partnership with this customer highlights the power of trained experts, reliable data practices, and end-to-end support in translating rigorous science into positive patient outcomes.