Please Wait...

Risk-Based Monitoring

The Increasing Role of Technology in Supporting ICH E6 R2

  • 0
  • 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:

Read More

RBM SaaS Success: Avoid Validation Issues

  • 0
  • 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?

Read More

Top 5 Criteria for Your RBM Software Selection

  • 0
  • 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.

Read More

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

  • 0
  • 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.

Read More

Why Your RBM System Should be SMART, Not Pretty

  • 0
  • 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.

Read More

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

  • 0
  • 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.

Read More

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

  • 0
  • 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.

Read More

3 Considerations When Implementing Risk-Based Monitoring Software

  • 0
  • 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.

Read More

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

  • 0
  • 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:

Read More

4 Considerations for Choosing Key Risk Indicators (KRIs)

  • 0
  • 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.

Read More

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

  • 0
  • 16 Aug

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

Read More

TransCelerate Companies Lead the Way in Adopting Risk-Based Monitoring

  • 0
  • 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.

Read More

New Apps Emerge for RBM!

  • 0
  • 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!

Read More

RBM is Advancing: 3 Keys in Planning

  • 0
  • 09 Mar

While Miami warmth and sunshine in February was undoubtedly a main draw for some SCOPE Summit attendees, for the risk-based monitoring set it was something more. It was about the opportunity for our diverse group of stakeholders to come together and give feedback in an area increasingly growing in importance - quality and risk management.

Read More

Get a First-Hand Glimpse into the Power of Mobile Application Generated Patient Data at SCOPE Summit 2016

  • 0
  • 18 Feb

The rapid growth of technology is revolutionizing the way clinical trials are conducted. Increasing adoption of smartphone use -- forecasted to reach over 6 billion by 2021 – combined with the growing biosensors market opens up new possibilities for a variety of healthcare-related uses. Innovative patient-centered mobile applications and biosensors now connect patients with physicians and other healthcare providers.

Read More

Pages

LEARN MORE OR SPEAK WITH OUR EXPERTS

CONTACT US
Leader in Clinical Trial
Management Solutions

Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

RT @DrugInfoAssn: What has been the biggest takeway for your organization so far? Tweet @ us using #DIA2017
bioclinica (Yesterday)
"Q" on #RBM & Total Quality Mgmt? @Kristin_Mauri has "A" @DrugInfoAssn #DIA2017 https://t.co/MqCxkmAfa0
bioclinica (Yesterday)
Kristen Mauri shows the @DIA audience the value of risk based monitoring https://t.co/ssJCfc9gQ5
bioclinica (Yesterday)
Innovation Theater Kristin Mauri of @bioclinica presenting on RBM & TQM @DrugInfoAssn #DIA2017 https://t.co/zsGroQcpiU
bioclinica (Yesterday)
Innovation Theater @DrugInfoAssn #DIA2017 Kicking off at 1. Perspectives on risk-based monitoring and TQM. https://t.co/mH6Npg0kD4
bioclinica (Yesterday)
RT @Xtalks: How Improving Site Payments Can Make You the Sponsor/CRO of Choice Tune in for this live webinar with @bioclinica https://t.co/…
bioclinica (Yesterday)

Latest Blogs: