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...
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...
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...
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...
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...
Jill Heinz, Director of Clinical Research, shares her insights on clinical sites and the value of clinical operations technology.
"He's off and flyin' as he guns the car around the track He's jammin' down the pedal like he's never coming back Adventure's waitin' just ahead! Go Speed Racer! Go Speed Racer! Go Speed Racer gooooo!" Readers of a certain age will recognize the theme song to Speed...
Webinar On Demand: Agatha Applications for Quality Management & Clinical TrialsAgatha joined partner Arithmos for a webinar that looks at the need for specialized solutions for managing quality documents and clinical trial information. We demoed the Agatha...
Addressing Compliance Requirements with Agatha at Tohoku University HospitalWhen The Clinical Research Data Center at Tohoku University Hospital needed a more efficient and effective way to manage clinical and quality documents, they chose Agatha. The Clinical...
Clinical trials are facing an increasing need to go virtual, and with that change comes opportunity and challenge. At the GCP Summit earlier this month, Agatha’s Head of North American Operations, Ken Lownie, hosted a panel of clinical trial experts to get their views...