Our Blog Archives - Clinion

To be compliant with US FDA 21 CFR Part 11 regulations, CFR Part 11 validation of electronic data management systems is mandatory. In simple terms, any computerized system involved in the clinical research process must comply with FDA 21 CFR Part 11. What is US FDA 21 CFR Part 11? It is basically part 11

Clinion CTMS – Discover, Transform and Enhance your Clinical Trials Clinical Trials are a humongous undertaking. They involve massive amounts of data, hundreds of people and many sites for investigation. Managing these trials in the highly regulated clinical research field is challenging. It involves the integration of various processes, risk management and adherence to stringent

Clinion CDMS – Solutions to deliver high quality, quick and productive clinical studies We at Clinion understand how clinical data can completely impact the cost, effectiveness and turnaround time of any clinical study. Clinion’s Clinical Data Management System (CDMS) works towards storing and managing EDC and Paper-based data of clinical studies. The clinical data gathered

Electronic Data Capture(EDC) is used to help medical device and pharmaceutical organizations accomplish the greatest effectiveness with regards to entering data, structuring a database and conducting analysis for clinical trials. EDC technology has developed as past worries about data integrity through human error and connectivity issues caused by less reliable IT systems have become a