Friday, 28 November 2014

Clinical Data Management System Helping to fast-track the drug development process

Clinical Data Management System

In today's research scenario, clinical trials find answer to the research questions by the means of generating data for proving or disproving a hypothesis. This produces large sum of clinical data which has to be organised in most reliable and flexible manner under an efficient management system called as Clinical Data Management (CDM). Clinical Data Management Services has now gradually developed its response to the ever-increasing demand from pharmaceutical companies to fast-track the drug development process and from the regulatory authorities to put the quality systems in place to ensure generation of high-quality data for accurate drug evaluation. The main objectives of CDM process is to collect the raw data, ease in monitoring or auditing, and to facilitate processing of the data.

Clinical Data Management System CDM is the process of collection, cleaning, and management of subject data in compliance with regulatory standards and thus adoption of CDM to drive forward drug research is gaining pace worldwide. It is found that CDM is the key corporate asset in today’s biopharmaceutical industry, and turning data into meaningful information is a critical core function for sponsor firms to make faster and more flexible assessment of the compounds with a specific indication. In forthcoming trials, a CDMS has become necessary to manage the huge amount of data. Many of the CDMS used in pharmaceutical companies are commercial, but there are few open source tool also. These CDM software are available free of cost and are as good as their commercial counterparts in terms of functionality. The open source software can be downloaded from their respective websites.

Electronic Data Capture (EDC) is an alternative which helps to reduce the clinical research cost by 20-28%. The use of EDC technology and eCRF to collect data in clinical trials has grown in recent years and has affected the activities of clinical research operations for industry sponsors, contract research organizations (CROs), and clinical sites. It is found that cost savings alone with EDC vs paper estimated about $60 million per drug. To encounter the particular demand, there is a constant shift from the paper-based to the electronic systems of data management. Developments on the technological front have positively impacted the CDM process and systems, thereby helping encouraging results on speed and quality of data being generated.

While companies are seeking faster access to clinical data, the integrity and quality of data being collected and transferred from study subjects to a clinical data management system (CDMS) must be monitored maintained, and quantified. This ensures a reliable and effective base for not only new drug application (NDA) submission and clinical science reports but also corporate clinical planning, decision-making, process improvement, and operational optimization. FDA has brought forward a critical path initiative in pushing study data tabulation model (SDTM) adoption to enable electronic regulatory submissions for sponsors of human drug clinical trials. SDTM was initiated and developed by CDISC. As a consequence, biopharmaceutical companies have been going major changes in re-evaluating their IVRS, CDMS, clinical trial management system (CTMS), and clinical safety system (CSS) to accommodate the growing needs and demands.

In conclusion, CDMS has now been emerged as an important and reliable tool to materialize the clinical data into useful information which can be further considered to establish as research evidence. Moreover, speed and efficiency of CDMS has also contributed to fast track the drug development process.

1 comment:

  1. Thanks for sharing this great article! That is very interesting I love reading and I am always searching for informative information like this.
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