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CDISC Migration

Study Data Tabulation Model (SDTM) and Analysis data Model (ADaM) are two standard structures set by the Clinical Data Interchange Standards Consortium (CDISC). These standard structures are to be adhered to during data submission of human clinical studies to regulatory authorities like the United States Food and Drug Administration (FDA). This transformation of raw data of a clinical study to CDISC standards is referred to as CDISC Migration.

Kreara has an expert team of professionals with sound knowledge in these standard structures, corresponding implementation guides, CDISC terminologies and the related ICH guidelines. The team keeps track of the latest developments and changes by subscribing to newsletters, actively participating in discussion forums and attending conferences.

As part of CDISC migration, the team develops the specification document and the annotated Case Report Form (CRF), which present the mapping of variables from raw database to the CDISC standards. The team also develops SAS programs which actually map the data from the raw structure to the standard structure and the SAS datasets containing data as per CDISC standards.

Testimonials

  • "Kreara's agile programming methodology was a welcome change from the previous outsourcing experience that we have had. With a team of 10 people which comprised of a business analyst, a scrum master and 6 programmers and 2 QA engineers, we were able to quickly ramp..." a US based Fortune 500 company

  • "SAS Programmers from Kreara has an exceptional experience across various therapeutic areas. They were also able to do a quick turnaround in the Phase IIB trial by providing the necessary TFLs within one week of database lock" Director Biostatistics of a European CRO

  • "It usually takes about three months to convert a legacy database into the CDISC format. Kreara programmers were able to do it in less than a month with the sound domain knowledge that they had in oncology and CDISC specifications" Director Data Management from a European Pharmaceutical Major

  • "While medical coding remains one of the most costly affairs in Europe, Kreara was able to successfully use the medDRA and WHODD to perform the medication coding at costs that were extremely competitive" Director Data Management of an East European CRO

quick contact

Quick contact info

  • Kreara Solutions Private Ltd.
  • T-4, 7th Floor, Thejaswini Building,
  • Technopark Campus,
  • Thiruvananthapuram (Dist),
  • Kerala State, India.
  • Pin: 695 581
  • Phone: (00)91 - 471 - 2527640
  • Phone: (00)91 - 471 - 3043049
  • Email:info@kreara.com
  • www.kreara.com
  • www.technopark.org