New ICH E6 regulatory guidelines and enabling technologies is changing the way clinical trials are being conducted posing a number of significant challenges to Pharmaceutical, Bio-Tech and Medical Device companies. Data Aggregation and Visualizations, Data Quality Oversight, Risk Based Monitoring, Central Statistical Monitoring, Vendor Oversight, Data Science, and Compliance have all become Key Issues.
scientist with microscope

The e-Clinical Agency is a consortium of seasoned subject matter experts who can provide the right consulting service and new technology platforms to address unique challenges.

We draw upon the latest e-Clinical trial technology, developed by a “best-in-class” list of independent suppliers. Our sole concern is recommending the right technology platform to meet the need.

And, importantly, when you select one of our suppliers, we are paid by them, not you.

Our consortium of client partners are subject matter experts in Phase I through Phase IV Clinical Trials, Risk Based Monitoring and Quality management, Data Management, Data Science, Clinical Informatics, Pharmacovigilance, Regulatory Affairs, Submission Ready Transformations, Clinical Data Hubs, who work together to develop precise recommendations, and action plans to meet your goals.

  • Do you need to get more from your e-Clinical systems?

  • Are you struggling with getting value for your legacy study data?

  • Do you want real-time reports and custom dashboards to easily identify key risks and actionable insights?

  • Do you need greater efficiency, transparency and improved compliance when sending clinical and safety documents?

  • Do you have gaps in your current quality management system including processes, documents and SOP’s that is preventing you from ICH E6 compliance?
If you have answered yes to any of these questions  Contact usContact Us