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.
What Is A Quality Management System For Life Sciences?
It is well known that Quality Management Systems (QMS) are essential for any industry, but what are they and how can they be applied to the life sciences sector? For businesses working in the life sciences and pharmaceutical sectors, a QMS is essential for the entire...
What is QMS in medical device companies?
Medical device companies often have to adhere to strict standards in order to operate. These standards help ensure safety and quality control for both the company and its customers. One of the most important tools used by medical device companies is a Quality...
What are 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.