Centralized Monitoring To Clinical Quality

The life sciences industry is faced with the daunting challenge of developing and introducing new drugs and therapies in a quicker and more cost-effective manner. The clinical phase is the most complex part of the drug development process, and it requires efficient planning, conducting, and monitoring of clinical trials to achieve the desired quality and obtain reliable study data that is appropriate for regulatory submission. Clinical monitoring cost is one of the major costs, accounting for one-third of the overall cost of clinical trial management to achieve higher data quality and better monitoring of patient safety.

Studies have shown that traditional ways of conducting frequent monitoring visits every four to eight weeks to investigational sites and 100 percent source data verification (SDV) do not necessarily result in higher data quality. In order to launch successful centralized monitoring practices, there must be effective process restructuring and cross-functional resources alignment, and the proper technology needs to be in place.

Restructuring the monitoring process:

Designing a realistic, efficient, complementary centralized monitoring plan with pre-defined key risk indicators (KRIs) and their thresholds, along with suggested action plans for the critical risk/issue(s), is key to adopting a centralized monitoring approach. The key risk areas, their measurements/metrics, and thresholds which need to be tracked during centralized monitoring should be identified upfront and monitored throughout the process

Technology:

Centralized monitoring is feasible only if the right technology is in place, ensuring the study data will be in the right format and can be monitored remotely in a timely manner. The integration of clinical and operational data from disparate sources — for example, EDC, CTMS, IRT, or e-diary etc. — are necessary for effective centralized monitoring.

For More Information: http://www.makrocare.com/centralized-monitoring-a-smarter-cost-efficient-approach-to-clinical-quality

Author:

Ashok Ghone, Ph.D. is Vice-President, Global Services at MakroCare USA. He has around 20 years of experience in the pharmaceutical and clinical research industry. Ashok has been involved in development of process, system and training related to risk-based monitoring and centralized monitoring at MakroCare, which offers these specialized services to biopharmaceutical and medical device companies to support their endeavors in implementation of the RBM approach.

MakroCare has an extensive experience and understanding of Clinical Investigation of Medical Devices and strong team of scientific, regulatory, clinical marketing and diagnostics who are spread across US, EU, Bric and Asean.