QMS 101: Pharmaceutical Quality Management System

QMS 101: Pharmaceutical Quality Management System

When people use the term Quality Management System, or QMS, they are usually referring to an integrated set of forms and processes used to track complaints, incidents, issues or problems from the time they arise until they are resolved.  A QMS is used to manage and...
What is remote monitoring in clinical trials?

What is remote monitoring in clinical trials?

On-site monitoring has long been a common operation during the development of clinical trials. However, recent technological developments are improving the way monitoring tasks are performed. Remote monitoring offers all parties involved in clinical research a fast...
What is an investigator site file (ISF)?

What is an investigator site file (ISF)?

The Investigator site file (ISF) is a crucial component of clinical research. Keeping an effective and compliant ISF is the best way for a clinical trial site to guarantee the effective and compliant development of clinical research procedures.   What is an...
Top 8 eTMF Features

Top 8 eTMF Features

Trial master files are essential for the completion of clinical studies. However, the management of TMF content can be very complex. eTMF systems represent the next step in clinical trial document management and promise to become an integral part of all future...