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CDISC India Network welcomes all enthusiasts to enter the universe of CDISC through the platform of Inklings Novelty Discovery Impartation Amelioration here!
Counting since the literal advent (December 2016), CDISC has finally arrived in India!
CDISC organization: CDISC (The Clinical Data Interchange Standards Consortium) is a global, nonprofit standards development organization with a worldwide team of staff and volunteer experts across the medical community. The benefits of implementing CDISC standards in research studies are numerous — fostered efficiency, enhanced innovation, increased predictability, complete traceability, improved data quality, reduced costs, streamlined processes—all ensuring the integrity of your data from end to end. Not only is implementing CDISC standards an industry best practice, it is now an FDA requirement for sponsors whose studies started after Dec. 17, 2016, to submit data in the data formats supported by FDA and listed in the FDA Data Standards Catalog. This applies to NDAs, BLAs, ANDAs, and subsequent submissions to these types of applications.
CDISC India group:
With the mounting clinical research skills in India, a support system within a grasp would only help a smooth connect and catch up with the fast pacing industry standards.
Hence, an exclusive CDISC group in India was much awaited. It’s a real delight to earn this approval in Q2 2018 which is surely a momentous milestone!
Notion: To channelize the routes of all current and prospective CDISC users under the ever-expanding branches of SDTM, ADaM, CDASH, Define Metadata and many more.
Vision : Build a one-stop plinth for all the Indian CDISC allies.
Mission: Amplify and explore the world of CDISC rudiments underneath a few teams/sub-teams.
Forthcomings:
- This quest would travel across various regions in India with the preliminary zones being Mumbai and Pune; to be extended to other regions soon.
- Forthcomings include germane webinars, Blogs, Speakers, Papers, seminars. Communication and details would keep rotating.
Stay pitched for the upcoming updates.
All those (from Mumbai and Pune for now, until further commencements) inclined towards membership, please reach out to Membership. Membership is absolutely free!!!
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