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Challenges in CDISC data transformation
Every drug data submission made to the US Food and Drug Administration (FDA) from December 2016 must comply with CDISC norms. However, most clinical data conversion tools available today cannot adequately resolve industry challenges, which include:
- Changing requirements, protocol amendments, and the addition of new therapeutic areas while working with multiple CROs and partners
- The lack of company-wide standards or firm-specific versions of industry standards
- Sluggish turnaround time due to competing priorities and operational overheads arising from data management
- Organic growth of systems, generating various point-to-point and manual tasks which lack scalability
These factors often make it difficult to collect data on time for meaningful analysis and reporting. The entire process, consequently, becomes inefficient both in terms of costs and timelines. The absence of end-to-end process flows and collaboration tools hinders execution – causing delays and a surge in spends which ultimately lead to unmet business needs for pharma and CROs.
Our Tech Solution
DIaaS is an integrated cloud-based platform and service suite for transforming data from multiple sources, aligned to industry or proprietary targets inspired by the CDISC. We enable cost-effective, high-quality, and near real-time availability of submission-ready data for pharma, medical devices, and CROs.
We are the preferred partner for top global pharmaceutical companies and CROs. Our customer base is a mix of pharma experts, CRO majors as well as luminaries from academia. Glimpses of our achievements so far in terms of CDISC transformation for regulatory submission are highlighted below:
DIaaS comprises of four key components:
- MDR - Comprehensive metadata repository with a built-in library of corporate, therapeutic and study-specific standards. It provides lifecycle management of metadata, versioning and up-versioning which allows building the knowledge base over time.
- DSP - Data standards platform which provides a visual graphical user interface (GUI) to map source-to-target standards with minimal programming required. It also includes auto-mapping and transformation based on MDR library and auto-creation of submission packages (SDTM annotated CRFs, Define.XML, and SAS code, among others).
- CDMS - Clinical discrepancy management systems with Data Validation Libraries containing Edit Checks for discrepancy management. It ensures comprehensive validation with OpenCDISC and additional custom checks.
- EMS - Clinical Event Management Systems which incorporate Lifecycle Management, Event Workflows, and Notifications with end-to-end traceability and data lineage.
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