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.
Bringing the TMF In-House A Guide for Sponsors
There is a lot of discussion about taking ownership of the trial master file (TMF). We wanted to understand what was behind this thinking of sponsors bringing the TMF in-house, so we reached out to an industry maven, Janine Penman of JPScientific, to fill us in. Who...
Adopting Clinical Operations Software? Do These 4 Things
Adopting clinical operations software can be an enormous undertaking, and there are many aspects that a sponsor, CRO, or clinical site will want to address before taking this step. 1. Do Your Research Before Adopting Clinical Operations Software Start with defining...
Calculating eTMF Savings and Payback: An ROI Calculator
An Ode to the eTMF. Sonnet 43, Revisited. Oh, eTMF, how do you save me? Let me count the ways. When I extol the virtues of an eTMF application, I am sometimes asked to be more specific and more quantitative. When I say confidently that an electronic Trial Master...
Can I Please Have a QMS App for Managing Clinical Quality?
Learn the difference between clinical quality management and manufacturing quality management.
Agatha Announces New Capabilities and New Extended and Premium Editions of Its Suite of Clinical and Quality Applications
Boston, MA, USA; Lyon, France; Tokyo, Japan. June 10, 2021, Agatha Inc. announced new features and capabilities for its clinical, quality, and compliance applications for life sciences companies. A total of 11 new capabilities were announced, focused on...
Agatha Inc Announces New PRISM User Interface
New UI Delivers High Performance and Accelerates Adoption Tokyo, Japan; Lyon, France; Boston, MA, USA. February 25, 2021. Agatha Inc. announces the official release of its new PRISM User Interface for the Agatha Suite of Clinical Operations and Quality...
The 10 Defining Attributes of a Fourth-Generation eTMF
Electronic trial master file solutions have gone through several evolutions from complex, highly customized, on-premises platforms to custom off-the-shelf solutions, and all the way to the latest evolution - cloud-based, easy-to-use applications. We are now seeing...
Who Needs an eTMF, Anyway?
Electronic systems for managing clinical study documentation emerged in the 1990s and have evolved through three generations. One of these applications is the electronic trial master file (eTMF). Who needs an eTMF and why use it? Read on to find out. Defining the...
Choosing an eTMF Solution? Focus on Value, Not Features
If you are in the market for an electronic Trial Master File system (eTMF solution), it is almost certain you have made a list of requirements that leads with compliance, functionality, ease-of-use, and cost. And if I had my way, I would stop you right there, on...