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.

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.

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.

About Author:

Dr. Ashok Ghone, Ph.D. is Vice-President, Global Services at MakroCare USA with an experience around of 20 years in the pharmaceutical and clinical research industry.