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|