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.

QMS For Biotech Companies

QMS For Biotech Companies

Biotech companies face unique challenges when it comes to product development and production. They must adhere to strict safety regulations, stay on top of rapidly changing technologies, and find ways to reduce costs without compromising quality or putting customers...

What Is A Quality Management System For Life Sciences?

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?

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...

The FDA audit trail requirements for clinical trials?

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

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...

Meet Agatha at the European TMF summit in London November 14 – 16

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.

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