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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 10 Defining Attributes of a Fourth-Generation eTMF

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?

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

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...

Bringing Clinical Operations Technology to the Clinical Site

Bringing Clinical Operations Technology to the Clinical Site

Sponsors and CROs have invested millions of dollars or more in automating clinical operations since the 90s. And every study they do is includes one or more clinical sites where patients are treated, and data originates. Yet, clinical sites trail behind in terms of...

4 Obstacles to Remote Monitoring

4 Obstacles to Remote Monitoring

At the Recent Clinical Quality Oversight Forum, I had a chance to give a presentation entitled “The Path to Successful Remote Monitoring (watch it on-demand).” For me, it was something of a culmination of all the research, interviews, and thinking I have done this...

5 Resources to Learn About Remote Monitoring for Clinical Trials

5 Resources to Learn About Remote Monitoring for Clinical Trials

The topic of remote monitoring of clinical trials has gotten enormous attention since February of this year, as travel to clinical sites became difficult and, in some cases, impossible. Whether at conferences (virtual, of course) or on-line, ClinOps leaders are...

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