Case Studies

Challenges in implementation of CDISC: Indian industry experience

  • In-house CDISC expertise
  • Synchronization between Clinical Operations and Biometrics team within organization is yet to be optimized which provides seamless CDISC deliverables
  • SOPs are not yet completely aligned to CDISC as per mandate and streamlining of processes takes time. Clinical Trial Industry requires specific therapeutic expertise
  • Big CROs with great experience in CDISC are still not preferred due to their pricing structures
  • No dedicated CRO to provide dedicated CDISC expertise for Clinical Studies
Sponsor Brief/Dilemma Problem Statement Problem Analysis Solutions Provided

·   A leading Indian pharma giant invited Eupraxia to present its capabilities in Pre-Clinical Trial data analysis and SEND submission package.

·   Eupraxia was assigned with 2-weeks’ repeat dose toxicology and toxicokinetic study to identify the challenges/ difficulties during the transcription of data from raw forms to excel and during conversion of that excel raw data to SEND format.

·   Sponsor’s Dilemma was to take go/no-go decision to partner with new Indian CRO

·  Sponsor wanted pre-clinical trial data analysis partner in India at Indian price point with global quality benchmarks for USFDA submissions. ·  Sponsor was looking for a trusted CRO which can deliver this. ·  Sponsor was not looking for the CRO who would help such critical studies on trial and error basis. ·  Sponsor wanted a plan to be presented in the meeting scheduled following week.   ·  To remove the gaps between existing data forms and SEND data standard, by conducting gap analysis. ·  Conversion of this raw data into SEND standard format to meet the regulatory requirement and standardize the in-house processes.   ·    Eupraxia Core CDISC Expert Implementation Team studied the sample raw data forms provided by Sponsor and identified the gaps between data capture on the forms and SEND standard. ·    Critical Data Issues identified and resolve suggested. ·    Programming was undertaken on war footing basis ·    CDISC Package delivered within tight timeline ·    Sponsor QA and Management appreciated Critical Data Issues that were identified by Eupraxia ·    Eupraxia suggested best data practices to implement
Benefits to the Sponsor & Eupraxia
  • Satisfied Sponsor’s toxicology core team accepted all suggestions of Eupraxia for USFDA submissions. The team has got rid of age-old practices of inefficient data management by aligning to CDISC/SEND standards. Both teams work as true partners. No regulatory queries that need Eupraxia involvement.
  • Entire Pre-Clinical Trial Data Analysis and SEND submission package work moved to EUPRAXIA for the bundle of 8 pre-clinical studies in the year 2019.
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