Challenge

Life sciences industries face challenges in managing diverse data standards and statistical output templates, resulting in process inefficiencies. Across the entire study build process, pharma companies have to deal with non-standard data, manual programming and disjointed downstream processing that leads to increased process time of study data tabulation models (SDTM). As a result, pharma companies are looking for an automated and integrated, metadata-driven, end-to-end solution, leveraging standards as the driving force.

TCS Solution

TCS ADD™ metadata repository is a ready-to-use, interoperable metadata driven AI solution that automates study build, enables robust governance through cross-departmental data lineage and rapidly transforms and generates submission-ready datasets for SDTM, ADaM, CDASH or any other industry data standard.Equipped with smart and flexible governance, the solution streamlines and maintains data from collection to submission through its Clinical standards registry. The TCS ADD™ Metadata Repository Platform also provisions a clinical study design workbench with automated data transfer agreements and study build capabilities, coupled with the ability to generate submission ready SDTM Data & Packages.

The solution comprises of the following core components: -

• Clinical standards registry and smart governance: Repository of multiple templates and standards, enabling cross-study and product reusability. Enterprises can leverage its workflow and smart governance capabilities to handle evolving standards with ease.

• Automated study build: Automates electronic data capture (EDC) study design from standards and templates, interconnecting processes across the entire product cycle.

• Integrated metrics and oversight: Intuitive metrics to assess usability of standards, allowing consistent governance across the cycle.

• Automated SDTM and statistical computing: Automated creation of ready-to-use submission packages using artificial intelligence (AI), providing a controlled environment for biometrics.

Benefits

Organizations can experience the following benefits with the solution

   1. Real-time SDTM availability

   2. Automates entire study setup build

   3. Reduced workload and Increased efficiency

   4. Standard library with smart governance

   5. Improved Data quality and oversight

   6. Increased compliance with regulatory standards

Key Facts

   1. Up to 30%, cost reduction in EDC study build efforts

   2. Upto 3-6 weeks’ time reduction in EDC study build efforts.

   3. Up to 70% reduction in SDTM efforts.