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Risk-Based Monitoring

Four Steps to Creating a Roadmap to ICH E6 R2 Compliance

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  • 29 Aug

Since the release of ICH E6 R2 in November 2016, we have been flooded with opportunities to attend and view webinars, seminars and blogs on the topic. While extremely educational, these industry-led learning sessions rarely provide sponsors or CROs with what you so desperately need… a practical guide to creating a roadmap to compliance. While Regulatory Affairs (RA) and Quality Assurance (QA) departments have likely read these new guidelines, holistic organizational education and awareness of their impact and how they affect the way in which we execute trials are still lacking.

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CRO Oversight Is Not Optional: In-House Technology Solutions Can Help

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  • 08 Aug

Ensuring regulatory compliance is quickly becoming a primary reason to consider implementing an in-house, risk-based management/clinical trial quality management system. When sponsors outsource to a CRO, I've found that they often feel as if they are absolved of knowing exactly what is happening, ignoring the need for documented, risk-based oversight processes and procedures.

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The Increasing Role of Technology in Supporting ICH E6 R2

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  • 16 Jun

As you may already be aware, a key recommendation in the latest revision to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH E6 R2), finalized in November 2016, is the use of a quality-based approach inclusive of risk-based monitoring (RBM). It also recommends centralized monitoring processes. These should complement and potentially allow you to reduce the extent and frequency of on-site monitoring, freeing up valuable resources and providing the opportunity to:

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RBM SaaS Success: Avoid Validation Issues

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  • 30 May

As the industry and organizations' experience with risk-based monitoring and quality management in clinical trials matures, we're seeing a shift in the type of RBM systems being used. While custom-built systems were once many sponsors' go-to solution, we're increasingly seeing the use of off-the-shelf, cloud-based software, otherwise known as Software as a Service, or SaaS. (Disclaimer: Good news to us. Bioclinica offers a SaaS-based RBM solution, ClearSite.)

So why is RBM SaaS picking-up speed?

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Top 5 Criteria for Your RBM Software Selection

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  • 20 Apr

There is increasing recognition of the importance of implementing risk-based monitoring (RBM) systems to aid with the monitoring and reporting of relevant risks in clinical trials, rather than relying on traditional methods based on disparate data sources and manual collation processes. Software-based RBM systems automate predetermined monitoring tasks, provide alerts for identified risks and can provide audit trails for regulatory submissions. However, all RBM systems are not the same.

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Does Your RBM System Support the Recently Revised Guidelines to Have a QMS in Place?

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  • 03 Mar

The latest International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6 addendum includes recommendations for ensuring quality management in clinical trials at the forefront. In particular, the new section 5.0 outlines recommendations for quality management, stating that "sponsors should focus on trial activities essential to ensuring human subject protection and the reliability of trial results" within the seven areas that are described below.

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Why Your RBM System Should be SMART, Not Pretty

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  • 09 Feb

There is long-standing recognition that Risk-Based Monitoring (RBM) is essential to ensuring the safety of your patients and the success of your clinical trial. Data quality and patient safety are also at the core of quality by design (QbD) initiatives, which focus on identifying key risks to subject safety, data quality and GCP/regulatory compliance, setting the foundation for RBM implementation.

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5 Reasons Why You Shouldn't Build Your Own Risk-Based Monitoring Tools

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  • 19 Jan

With risk-based monitoring (RBM) gaining traction in the clinical trial industry, you may be wondering how best to implement an RBM program at your company. Many companies prefer to use RBM software provided by an outside vendor, such as Bioclinica's ClearSite. However, other companies may decide to build their own RBM software or tools in-house.

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Meet the Bioclinica eClinical Team: Kristin Mauri, Global Head of Risk-Based Monitoring

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  • 18 Nov

Bioclinica's suite of eClinical solutions is designed to make your next clinical trial easier for you, your investigators and even your subjects. Our flexible and innovative eClinical solutions are supported by a team of people who have experience in all facets of clinical trials and help our clients seamlessly adopt new technologies and processes to improve their trials. Our team members are invaluable to our success, so we wanted to highlight a few of them in a "Meet the Team" blog series.

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3 Considerations When Implementing Risk-Based Monitoring Software

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  • 02 Nov

With regulatory agencies placing greater emphasis on risk-based monitoring (RBM) in clinical trials, the use of tools for RBM has become more and more crucial to success within the industry. If you're considering adopting an intelligent monitoring solution or if you're in the early stages of implementing such a tool, it's important to set yourself up for success early on by keeping a few things in mind. In my experience working with customers to implement Compass, I've learned a few key criteria that companies should consider to ensure RBM success.

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What Effect Does ICH E6 R2 Have on Risk-Based Monitoring and Overall Quality Risk Management?

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  • 17 Oct

Last week I hosted a webinar called "What Effect Does ICH E6 R2 Have on Risk-Based Monitoring and Overall Quality Risk Management?" The webinar focused on the recent revision to the ICH Guideline for Good Clinical Practice (E6 R2), which primarily addresses quality management with a focus on risk identification, evaluation, control, review and reporting. During the session, I discussed:

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4 Considerations for Choosing Key Risk Indicators (KRIs)

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  • 14 Sep

As a project manager and subject matter expert for Bioclinica's Compass RBM software, I've seen more and more companies turning to intelligent monitoring tools to track site performance and put their risk-based monitoring strategy into practice. When setting up a tool such as Compass, it's essential to choose the most important aspects of your trial to track in order to monitor site performance and identify areas on which to focus the most attention.

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Risk-Based Monitoring Cost Savings: The Icing on the Cake Not the Cake Itself

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  • 16 Aug

Reducing monitoring costs continues to be the primary driver to adopting risk-based monitoring (RBM). But should that be the leading metric?

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TransCelerate Companies Lead the Way in Adopting Risk-Based Monitoring

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  • 06 Jul

I recently had the opportunity to attend DIA. While listening to the panelists, I realized TransCelerate companies appear to be the furthest along in their journey of risk-based monitoring (RBM), and even so, RBM is still relatively new for most of them.

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New Apps Emerge for RBM!

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  • 09 May

App xChange adds Virtual Onsite Monitoring (VOS)

In advising and providing consulting to many different companies in recent years making a switch to risk-based monitoring (RBM) it's become apparent to me that the opportunity to improve patient safety and enhance data quality is the top reason for adoption.  Later this year when the revised ICH E6 (R2) guidance goes into effect we will have even more incentive to adopt RBM!

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