Data Management

The success of any drug product development mainly relies on relevant and accurate data. How the data are collected, analyzed and represented has significant impact on the successful progression of the drug from lab to market in accordance with regulatory requirements.

Our clinical data management processes, expertise and technology are developed to make each step of your clinical trial data management process more accurate and efficient for Phase I-IV in wide range of therapeutic areas.

Our CDM Team is Well-Versed with:

  • Current Good Clinical Data Management Practices (cGCDMP)
  • International conference on harmonization Good Clinical Practices (ICH-GCP)
  • 21 CFR Part 11 Compliance
  • Health Insurance Portability and Accountability Act (HIPPA) Requirements
  • Applicable Regulatory Guidelines

Katalyst’s End-to-End Clinical Data Management Services include:

  • paper Case Report Form (pCRF) and electronic Case Report Form (eCRF) design, development, review, Tracking and Processing
  • Clinical Database design and development, Setup, testing, validation
  • Clinical Trials Medical Terms Coding (MedDRA, WHO-DD, ICD-9 & Client Dictionaries)
  • Clinical Trail Data Entry, Review, Analysis, Migration, Loading, validation
  • Clinical Trial Data Collection, Storage, Protection, Retention, Analysis, Sharing, Reporting
  • Clinical Trial Data Capture, Either Paper-Based or Electronic (EDC)
  • Electronic Data integration and transfer
  • Quality Control Activities
  • Medical Dictionary for Regulatory Activities (MedDRA)
  • World Health Organization Drug Dictionary (WHO-DD)
  • Serious Adverse Event (SAE) Reconciliation
  • Clinical Database Transfers
  • Clinical Database Lock
  • SAS datasets
  • SAS XPORT transport files
  • EDC Helpdesk Support 24/7
  • On-Site and Off-Site Clinical Data Management Services