Featured Articles
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Why Open APIs Are Critical For Clinical Trial Software
12/14/2020
Today’s modern clinical trial requires robust and purpose-built eClinical solutions. One of the essential capabilities you must ensure exists is the ability to integrate with other systems through Open APIs.
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How To Create A Digitally Connected Clinical Trial Ecosystem
11/18/2020
Sponsors and CROs’ ability to access and collaborate with a research site is essential to the success of every study. As study sites “come on-line,” Sponsors and CROs are in a unique position to harness this digitally connected network of sites to turn on remote site access and Source document review/verification (SDR/V), and streamline workflows. In this article, we examine the key quality outcomes and technology recommendations associated with digitally accessing the site eISF.
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Six Reasons Why Sites Should Use The eISF Reference Model
11/18/2020
The Electronic Investigator Site File (eISF) Reference Model is the industry standard for setting up and managing an Electronic Investigator Site File. The rise in the eISF, coupled with an increasing need for real-time collaboration and document exchange among sites and sponsors/CROs, mandates the need for an eISF Reference Model. Here are six benefits of an eISF Reference Model.
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5 Essential Steps To Remote Site Access
9/28/2020
Sites, sponsors, and CROs now perform the bulk of their clinical trial operations by logging into cloud-based systems. As you evolve your monitoring and site management strategy to a remote approach, we are providing you with the 5 essential considerations to focus on to ensure site acceptance, site adoption and a successful implementation of your remote strategy.
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Seven Things Your Remote Monitoring Solution Needs To Ensure Success With Study Sites
9/16/2020
Remote site monitoring platforms are now a requirement in clinical research operations. While accelerated to mitigate COVID disruptions to site-access, the pivot to remote site access will be the new normal. This article highlights how to select the remote site monitoring solution for your clinical trial.
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Your eTMF And Your Study Sites: How To Close The Document Gap
9/8/2020
Not all sponsors and CROs that select and implement an Electronic Trial Master File (eTMF) solve the bottlenecks and inefficiencies that the system was selected to target. Why? Often, during the vendor selection process, organizations undervalue the need for site acceptance, disregard the impact of vendor support teams, overlook critical implementation processes, and don’t fully understand the correlation between software capabilities and the bottlenecks they address. This article addresses some common friction points and how to address them.
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How To Avoid Remote Site Monitoring Failures
9/8/2020
Remote site access, monitoring, and SDR/V are essential to mitigate COVID-19 disruptions to clinical trials in the short-term and to accelerate the research industry in the long-term. However, one doesn’t have to look far to find failed attempts at remote site monitoring. As an industry we are positioned – and poised – to get it right this time around, this article explores insights as to how to avoid these failures.
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9 Ways Your Technology Vendor Should Support Global Compliance In Clinical Research
9/8/2020
As the number of global clinical trials continues to rise it is important to understand the global compliance requirements needed for technology being utilized by your organization. This knowledge will empower you to select vendors that adhere to these requirements and support your ability to take on studies or scale participating sites regardless of their geolocation.
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Simple SOP Updates Every Research Site Needs To Succeed At Remote Monitoring
9/8/2020
Today’s crisis climate is creating a dichotomy in clinical research. As a result, sites are closing, medical facilities are enforcing access restrictions, and there are constant delays or stoppage of non-essential studies. On the other hand, this health crisis is highlighting the critical need for clinical research due to ongoing COVID-19 trials. As a result, clinical researchers are asking questions and seeking workarounds to continue operations in response to site-specific adjustments. One central issue has surfaced — how do we continue to maintain compliance when working from home?
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Impact Of COVID-19 On Clinical Trial Operations: How Leaders Are Changing Their Transformation Agendas
9/8/2020
COVID-19 radically disrupted clinical trial operations and forced an acceleration of the transformation agendas leaders had in place pre-crisis. While the acceleration of pre-crisis transformation agendas in clinical trial operations will be measurable, it will not leap to a 10+ year horizon. This blog takes a deeper dive into these changes and how it will affect the industry.