CDISC Services [SDTM & ADaM]
- Consulting for CDISC Standards
- SDTM conversion from Specifications to Define files
- ADaM Implementation
- Sponsor Designed Standards Implementation
- Customized CDISC solutions
- Compatibility with any version of the SDTM Implementation Guide
- Statistical programming using ADaM derived datasets
- SDTM & ADaM Packages Review & Validation
CDISC [SDTM & ADaM] -Is it regulatory requirement?
Regulatory authorities require data in standard format which is implemented over the globe. Clinical Data Interchange Standards Consortium (CDISC) has developed the various standards which include required standards Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM). FDA has been already endorsing and reviewing CDISC standards since long back. FDA & PMDA has been already implemented CDISC standards and other regulatory authorities are also in process of the same. The data standards submission is becoming more important and challenging as FDA’s latest published guideline on December 2014 indicates that submission has to be done in CDISC standards for trials started after December 2016. – FDA Guideline
Why Data Standardization?
The usual data would not be in a format that could be used for the presentation of the data to the regulatory authorities and this requires data standardization and conversion. The challenge is even bigger when clinical studies are conducted for many years, and the SDTM standards not followed while the studies were conducted, and such legacy studies are part of a submission. This demands significant metadata logical mapping and programming, in addition to deep expertise in CDISC Standards and understanding of clinical data.
SDTM and ADaM define a standard structure for study data that are to be submitted as part of a product application to a regulatory authority. The implementation of data standards brings lower development cost with less time to market path.
How Can Karmic Lifesciences Help?
Karmic Lifesciences can successfully convert the unstructured data into standard format with our proprietary process and accelerators. Our processes enable faster, efficient and reliable conversion of existing clinical trial data to standard domains that would be part of the submission to the regulatory authorities for their review and approval.
Our conversation process is powered by standard operating procedures (SOP) which embed best practices of CRF annotation, logical mapping, validating datasets by tool & double programming efforts, report generations and guidance documents for all the activities.
Karmic Lifesciences Expertise
Karmic Lifesciences has a team of CDISC expertise professionals to ensure there is an accurate interpretation of SDTM and ADaM that is identified, documented, managed, implemented consistently and most importantly communicated at right stage. Our team members are trained in-house on CDISC Standards Fundamentals. Our programming expertise allows us to apply an efficient and systematic process to ensure consistency and accuracy of the final product.
Karmic Lifesciences delivered 94% projects by beating the timeline. Karmic Lifesciences has the flexibility and resources to work with specific needs. Karmic Lifesciences each process is powered by SOP and every tool is validated.
We offer seamless, cost-effective solutions for your electronic data submission needs, meeting the standards of regulatory authorities. We can develop a complete strategy for the conversion process by drilling down to the details of each database.
Through the successful completion of more than 60 projects for a variety of sponsors, Karmic Lifesciences has gained experience and got expertise in CDISC standards. We have a solid understanding of the expectations of regulatory authorities with respect to submission of data and all associated documentation.