Newsletter | July 17, 2019

07.17.19 -- The Challenges And Opportunities Of RBM Implementation


The best technology succeeds in the background. Introducing Signant Health (formerly CRF Bracket) and the industry’s most comprehensive patient-centric suite for clinical research. Uniting eCOA, eConsent, patient engagement, IRT, clinical supplies, and endpoint quality, Signant makes it easier to participate in — and sites and study teams to run — clinical trials. Take a significant step toward patient-centricity at

Featured Editorial
The Challenges And Opportunities Of RBM Implementation
By Ed Miseta, chief editor, Clinical Leader

In March 2019 I had the opportunity to interview Jennifer Newman, global project leader, regulatory affairs/clinical operations for Celldex Therapeutics. Newman was once part of the largest implementation of risk-based monitoring (RBM) and was able to share insights from her experience. This is part one of a two-part Q&A article.

Lessons Learned From An RBM Implementation
By Ed Miseta, chief editor, Clinical Leader

Our interview with Jennifer Newman, Celldex Therapeutics, continues here. Part two of this two-part Q&A discusses the benefits and challenges of risk-based monitoring (RBM) and what companies should be prepared for when adopting the technology.

Industry Insights
5 Critical Steps In Developing Your Clinical Supply Chain
White Paper | By Tracy Chase, Bellwyck Pharma Services

Clinical supply chain planning is imperative, as it allows you to develop a strategy and best practices for quickly and efficiently delivering goods to support all the needs of the trial. But, where do you begin?

Empowering Sites To Ease The Administrative Burden Of Clinical Trials
Article | By Jason Methia, Veeva Systems, Inc.

Penn Medicine offers tips for sites considering the use of technology to reduce the administrative burden in clinical research.

Top 5 Events That Can Impact Your Clinical Supply Chain
Article | By Sylvia Tsengouras, Thermo Fisher Scientific

Review practical solutions for “small changes” in the clinical supply chain that can wreak havoc if not planned for in advance.

4 Innovations In Clinical Trial Design That Are Streamlining Trials Today
Article | By Nick O’Brien, Medrio

Any organization seeking ways to keep their research moving forward in the face of rising costs and complexity should be evaluating whether new approaches to clinical trial design can accelerate their progress toward their goals. Here are a few designs researchers are experimenting with and how they can maximize speed and cost-efficiency in clinical research.

Strategies For Efficient Clinical Supply Management And Forecasting
Article | By Kristen DeVito and Jan Ehrich, Catalent

Engaging clinical supply management and forecasting adds value by evaluating different response strategies and contingency plans and can identify supply solutions that minimize or even potentially avoid supply chain disruptions.

Real-Time Monitoring Of The Digital Patient
Article | ICON Plc

The shift of clinical assessment from the controlled environment of a trial site to the uncontrolled environment of a patient's home is a considerable challenge. Read about ICON’s creation of a suite of wearables that could be combined and deployed in a nonclinical setting and tailored to specific therapeutic areas.

Bench To Clinic: Planning For A Successful Translation
Webinar | Rho

This webinar will provide an overview of the clinical, nonclinical, CMC (chemistry, manufacturing, and controls), and regulatory activities necessary for a successful IND submission.

Most Important Attributes For EDC Provider Selection: Development vs. Post-Marketing
Infographic | ISR Reports

ISR recently surveyed 148 respondents on their experience with electronic data capture (EDC) systems, which have become essential tools to appropriately capture, review, and present clinical trial data.

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