Risk-based management of clinical trials is the methodology that is currently recommended by regulators, however it has some direct consequences on monitoring and clinical trial oversight.


The transition plan identifies the team responsible for a successful transition, the tools, techniques, and methodologies required. Evaluate data needs to identify and calculate completeness of artifacts contained outside of the primary system.


It is a comprehensive, industry-agreed, multi-layered view of the key business processes required to run an efficient, effective and agile digital enterprise.


Reiterate the overall project goals, restate the purpose and stay passionately neutral during the process. Take control of your organization data with effortless analysis, using one simple quality management software solution. The key behind successful clinical trials is transparency and seamless access of data.


Oversee study level performance against agreed upon plans, milestones and key performance indicators by using company tracking systems and project timelines (e.g.


Want to check how your eTMF Processes are performing? You don’t know what you don’t know. Find out with our eTMF Self Assessment Toolkit: