Details of person submitting   
Name Jagat Mishra
Organisation Parexel
Email jagat.mishra12@gmail.com
   
Details of abstract   
Title of abstract  eSouce – Novel approach in Data collection in Clinical Research
Abstract 

Clinical research bring new therapies for patients and data is food for clinical developments, currently industry is collecting data via electronic and paper formats which have few limitations as high upfront cost, lack of technical knowledge and resistance to change, but latest technologies as eSource refers to an electronic application and/or device that allows direct entry of source data and to directly identify some of these data as CRF (Case Report Form) data e.g sensors, ePRO, EHR/EMR, Devices as (mHealth, wearables) they offer competitive edge over legacy data collection by avoiding data duplication, Reducing the opportunity for error, Ensuring accuracy & completeness of data , promoting real time data entry and analytics, reducing workload at sites, cost management, avoiding paper components etc. as only protocol mandated source data should be recorded and part of the eSource system which is accessible to the Sponsor hence in order to improve the quality of the data collected in clinical trials it is imperative that all advantages and disadvantages of the proposed system are weighed against each other and benefit/risk evaluation is required before adoption, eSource system should be fully compliant to 21CFRPart 11 and other To be acceptable, an eSource system and application should be customized in line with legal requirements and ICH GCP, validated, secure and maintained and must comply with latest regulatory changes as GDPR etc. at last eSource has potential to redefine legacy data collection workflows and results in data transparency leading to greater study control and assist in faster time to market

 

First learning objective Esource adoption in Clinical trials
Second learning objective EHR/EMR integration with EDC
Third learning objective
   
Presenter Details  
Name  Jagat Mishra 
Organisation Parexel
Job title Clinical Data Analyst