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Catalyst Partner for Clinical Data Management

Task Based Approach

  • Medical Coding using latest versions of MedDRA and WHODrug dictionary
  • Data Anonymization
  • CRT validation
  • Data validation
  • GCDMP compliant robust SOPs

Application on Expertise

  • 16+ Yrs of experience in CDM
  • Flexibility in managing any application viz: LifeSphere EDC ,OC, OC-RDC, InForm, Rave
  • Capable of handling PDC, EDC and Hybrid studies

Subject Diary

  • Design of Paper/e-Diary (eCOA)
  • Seamless integration of eCOA with LifeSphere EDC
  • Improves subject monitoring and safety through real time reporting

IP MANAGEMENT

  • Set up randomization functionality/IWRS with EDC
  • Ensure optimized, streamlined supply chains
  • Uninterrupted integration with EDC, CTMS and eCOA solutions​

RBM

  • Data visualization/dashboards
  • Easy analytics
  • Exploration of data

First Data Services team to initiate FTE-FSP outsourcing in India

End-to-end activities in Clinical Data Management 

Consistent presence at SCDM conference as speakers

Tutorials for Pharma/Biotech companies 

 

Innovation- Excel-based Indigenous CDM Platform

  • No IT support cost
  • Audit trail for core data
  • Customizable Data Listings with filters
  • Direct data exported into Statistical Analysis Report

Medical Coding by Medical Experts

Dedicated coding engagement

SETUP AND SCOPE
  • Medically qualified professionals
  • Experienced in most TAs & industry standard dictionaries
  • Medical Coding of AE, CM, MH using MedDRA, WHODrug, Legacy dictionaries
  • QC of terms coded by other CROs

COST AND QUALITY

  • 30 % cost benefits
  • Minimum supervision
  • Remote working
  • Error rate < 0.05 % across FTE & transactional models
  • TAT met at all times
VALUE ADDITIONS
  • 1 day turn around time
  • Daily task completion across geographies & studies
  • Internal coding repository maintained, shared with clients
  • Participation as expert review panel at UMC user group conference
  • Valuable contribution for dictionary upgrades to MSSO and UMC
  • Prior & Latest versions of dictionaries available

RESULTS / OUTCOMES

  • 2 million terms coded

Case Studies

DATA MANAGEMENT CASE STUDY 1

Program Management with Platform Integration between eCOA and LifeSphere EDC.

DATA MANAGEMENT CASE STUDY 2

Task-based medical coding activity: Medical Coding of Adverse Event, Medical History and Concomitant medications using the latest version of MedDRA and WHODrug respectively.

DATA MANAGEMENT CASE STUDY 3

FMCG trial conducted by a global sponsor with stringent timelines.