Introduction

The spirit of enquiry and the pursuit of truth have been time immemorial an inherent aspect of mankind. This has been demonstrated through the years by scientists committed to research on animals and humans. To this day and age, these experiments have continued but with increasing emphasis on safety and protocol. Thus has been born the modern day clinical trial.

In today’s scientific and medical world, various issues in clinical trials and research have permeated every society and every field in medicine. Ethics and in particular the quality of research are two aspects of clinical research which have been the focus of attention in the last two decades. The advances in technology have greatly helped the quality of clinical research especially in the area of clinical data management. It is therefore of utmost importance that there is human expertise to match the technology so as to achieve optimum quality in the conduct, analysis and report of a clinical trial.

This dire need to provide quality data management and training of personnel, has spurned on the creation of “CMC CREDAT” (Christian Medical College CREdible DAta and Training), a Clinical Data Management Centre at the Department of Biostatistics, Christian Medical College, Vellore, India in collaboration with the Dept. of Clinical Pharmacology, Christian Medical College, Vellore, India, WHO/TDR, CDMTDR, Thammasat University, Bangkok and Shangai Secondary Military Hospital, China. It is hoped that this facility and expertise would be used to impart a training of the highest order and a quality data management service for clinical trials throughout the developing world.

Our Goals

  • To provide quality service in the conduct of clinical trials data management in compliance with GCP ICH and FDA regulatory requirements and guidelines.

  • To conduct training courses in Electronic Data Capture and Audit Trail software, Serious Adverse Event and Drug coding using software, Principles of Quality Assurance and Quality Control and Standard Operating Procedures (SOP) writing for clinical data management.

  • To provide Biostatistical services in the analyses and report writing.

Address

Department of Biostatistics
Christian Medical College
Bagayam
Vellore 632002
PH:0416-2284205
FAX: 0416-2262703
Email:biostats@cmcvellore.ac.in


© 2008 CMC Credat