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.
Request for Sponsor Reference
Sponsor Brief/Dilemma Problem Statement Problem Analysis Solutions Provided
·   Global Pharma Sponsor using automated Tool for SEND package generation was left alone when USFDA had quintessential queries on the package creation

·   Sponsor was in real trouble and wanted to scrap the automated tool usage. However, lot of money was invested buying the tool so sponsor was also looking for cost-effective CRO partner with real expertise.

 ·  Sponsor looking for consistent, high quality SEND dataset package creation, for variety of study designs, from various data sources

·  The company initially developed the SEND package using third party SEND tool, but found with lack of SEND compliance and costly

·  Sponsor needs cost effective CRO partner which can manage SEND submission package creation with the very latest versions of the SEND Implementation Guide (SENDIG).

·  Additionally, the vendor needed the ability to seamlessly convert their pre-clinical data to the new SEND standard.

 

 ·  The vendor of the automated tool provider was a team of software developers, with no CDISC SEND seasoned champion. USFDA critically review every package; it is not biased for any global brands of service providers, CROs or pharma giants during review process.

·  The automated SEND package creation tool has quintessential problem of SENDIG interpretation. This is too technical for “only software developers” to understand and implement. It needs thorough clinical programming experience in Clinical Trials (not BA/BE studies).

·  Spnor Toxicology Team had no idea of SEND. Team work was very important to make this team appreciate principles working behind CDISC/SEND package creation.

 ·    Eupraxia Core CDISC Expert Implementation Team started from scratch and disregarded all the tool based packages.

·    Critical Data Issues identified and resolve suggested.

·    Eupraxia Programming Team introduced edit programming checks that led to 95% of manual intervention reduced, ensured data consistency, perfected data traceability between interdependent datasets- resulting into highly compliant quality SEND datasets

·    CDISC Package delivered within tight timeline

·    Eupraxia suggested best data practices to implement
Benefits to the Sponsor & Eupraxia
  • Satisfied Sponsor’s toxicology core team improved its SEND package understanding, stopped using automated tool as a black-box, appreciated systematic programming to improve compliance and quality of submission package.
  • Eupraxia is very cost effective solution provider. Entire Pre-Clinical Trial Data Analysis and SEND submission package work has now moved to Eupraxia from last quarter of 2019

Request for Sponsor Reference