Our data scientist team is highly skilled and experienced in assisting clients with clinical data standardization across all therapeutic areas in compliance with CDISC standards. They are actively involved in PhUSE industry working groups, contributing towards shaping the future of data standards. You can be hence assured that Vita Clinical Solutions offers up-to-date intelligence and solutions to clients looking to develop “submission-ready datasets”. Our CDISC implementations enhances efficient data analysis and reporting, including regulatory review. ​

​Our Statistical Programming and Data Submission team is well versed in CDISC standards and have in-depth knowledge and experience in producing FDA (Global Regulatory Body) (FDA, EMA, Etc) compliant datasets and TLFs towards submission. We take an active role in CDISC initiatives to help the industry simplify and standardize data mapping, review and submission process. As such, our team has supported multiple sponsor companies to establish CDISC, SDTM and ADaM standards at a program and therapeutic area level. We have been involved with multiple successful NDA submissions to the FDA and have built solid expertise in ensuring all the clinical data deliverables from VDS are ‘submission-ready’.

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Regulatory Data Standards and Submission Services

  • SDTM annotation of CRF (aCRF) ​

  • CDISC Compliance Checks using Pinnacle 21 Validation

  • Define.xml generation

  • Reviewer’s Guides for SDTM and ADaM

  • Integrated Summaries of Safety and Efficacy (ISS/ISE) support

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CDISC Implementation Services

  • SDTM and ADaM Implementation Consulting ​

  • Creation of ADaM datasets

  • Conversion of current/legacy data into SDTM datasets

  • CDISC Libraries

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Case Studies

At Vita Clinical Solutions, we’ve had the privilege of partnering with some of the most innovative names in the pharmaceutical industry. Our case studies showcase the breadth of our work, highlighting key projects that have revolutionized drug lifecycle development. From early-stage research to market-ready solutions, we invite you to explore these success stories that underscore our commitment to excellence and innovation.

Manufacturing Case Study

Rapidly Expanding Manufacturing Capacity

ClinOps Case Study

Providing Niche Clinical Ops Talent