Aggie’s Insights
We’re on a mission to learn everything there is to know about clinical research and clinical trial management. We’re sharing those insights with you. A little research, a lot of interviews, some great customer stories, and even more.
The FDA audit trail requirements for clinical trials?
Audit trails are a critical requirement in clinical trial management systems. These computer-generated records capture all the activity in the system and are valuable tools to maintain a high level of data integrity and are extremely useful to study teams and...
Key Elements of Pharmaceutical Quality Management Systems
The pharmaceutical industry has undergone significant changes over the last decade. A greater emphasis is put on cost control, while public health concerns call for increased efficiency. This transformation has led to new challenges for quality management systems...
QMS 101: Pharmaceutical Quality Management System
Discover the usefulness or pharmaceutical quality management systems and the benefits they offer life sciences companies.
Meet Agatha at the European TMF summit in London November 14 – 16
f you are headed to the European Trial Master File Summit in London on November 14th – November 16th, then make sure you visit Agatha Inc. booth.
Also, join Ken Lownie’s session as he discusses the evolution of the TMF from file cabinet to process hub.
NS Pharma improves its Quality and eTMF management with Agatha
How Biotech NS Pharma improves its Quality and eTMF management with Agatha. Listen to Arthur Mate, Senior Quality Director explanations.
What is remote monitoring in clinical trials?
Discover the importance of remote monitoring in clinical trials and the best remote monitoring practices.
What is an investigator site file (ISF)?
Discover the importance of investigator site files (ISF) in clinical research and the best methods to keep an organized ISF.
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...
Agatha Gold partner of the Clinical Quality Oversight Forum on October 24-26, 2022 in Philadelphia, PA
If you are headed to the Clinical Quality Oversight Forum in Philadelphia this October, then make sure you visit Agatha’s booth.
Or better yet, register for Ken Lownie‘s session: What Does a QMS Designed Explicitly for ClinOps Look Like?
Wednesday, October 26 • 11:15am – 11:45am