Industry Program in Clinical Trails , Regulatory & Data Mana

A Clinical Trial Management System (CTMS), is a customizable software system used by the biotechnology and pharmaceutical industries and clinical research institutions to manage the large amounts of data involved with the operation of a clinical trial. It maintains and manages the planning, preparation, performance, and reporting of clinical trials, with emphasis on keeping up-to-date contact information for participants and tracking deadlines and milestones such as those for regulatory approval or the issue of progress reports.

Clinical trial is intended to find answers to the research question by means of generating data for proving or disproving a hypothesis. The quality of data generated plays an important role in the outcome of the study. Often research students ask the question, “what is Clinical Data Management (CDM) and what is its significance?” Clinical data management is a relevant and important part of a clinical trial. All researchers try their hands on CDM activities during their research work, knowingly or unknowingly. Without identifying the technical phases, we undertake some of the processes involved in CDM during our research work. This article highlights the processes involved in CDM and gives the reader an overview of how data is managed in clinical trials.