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Practical Risk Based Monitoring Methodologies

Putting RBM methodologies into practice

eClinical Greetings from Barcelona!
Jonathan Andrus
After a few crimps in the travel plans thanks to another winter storm hitting the US, everyone arrived safe and sound in sunny Barcelona for our second Annual European User Conference. It was two days of quality time with our customers and partners (recapped here in a news release).

CTMS
No surprise, our widely-used OnPoint CTMS proved to be the most popular product track. OnPoint users are a passionate group, happy to share lessons learned with peers in other organizations. What came up again and again in sessions like one led by Ziyad Abushima, Project Leader Processess & Systems, Clinical Operations at Biosense Webster, is OnPoint's power and flexibility. Whether big pharma, a CRO, or a growing start-up, OnPoint fits the needs of any clinical trial or organization.

Fit and flexibility rated high on the list of must-haves particularly with sponsors who rely heavily on CROs. Many cited lack of flexibility as a serious drawback that led to replacement of their legacy systems.

We were reminded that while a CRO may be doing day-to-day study management, it's the sponsor who is "on the hook" with regulatory authorities. Sponsors must demonstrate ethical and compliant conduct and the CTMS must support this. OnPoint users also remarked about the high degree of collaboration between sponsors and CROs made possible by a SharePoint-based front-end.

Clinical Supply Optimization

Janssen's Buz Hillman outlines the Optimizer advantage. That's me taking notes on the laptop!

Moving to another product track, Optimizer, the clinical supply management session led by supply management expert Buz Hillman of Janssen was popular. He uses our forecasting and simulation technology on all of their studies and is a big fan. (Check out the guest blog 6 Disasters that Can Be Averted Using Predictive Clinical Supply Planning or watch a video interview and pick up some pointers from Buz on where to shave waste and costs in the supply chain).

Risk-Based Monitoring
Risk-based monitoring was a burning hot topic. Our keynote speaker was Mireille Zerola, Global Project Team Leader for RBM implementation at Boehringer Ingelheim. She gave practical advice about putting RBM methodologies into practice, drawing on her company's journey in implementing its own set of RBM tools, processes, and change management, as well as her experiences serving on TransCelerate BioPharma's RBM work stream.

Mireille reminded us just how far we've come since the days of three-part NCR forms, faxes, hand-written queries, and manual tracking. "The world is changing," she said and asked boldly, "Are you ready?" She made us think about how our jobs will look quite different in the not-so-distant future as well as the way organizations conduct clinical trials.

She noted regulatory authorities support RBM and that guidance from the FDA, EMA, and PMDA are there to help with successful implementation. She urged time is of the essence as changes are on the horizon with ICH E6. Delving into surrounding topics, Mireille asked: "How prepared will your organization be on the RBM, quality management and risk-based management front? How about documentation in your trials?"


RBM Enabling Technology
Also speaking on RBM was BioClinica's own Courtney McBean, who drew a standing-room-only crowd. Attendees showed interest in the practical implications of adoption when it comes to site management, source document review and remote review versus source document verification.

Courtney spoke about the changing role of monitors and the importance of ongoing management of site relationships and compliance oversight by site monitors. She talked about new approaches and technology used in "Intelligent Monitoring" that bring efficiencies and insights and impact quality in clinical trials. (More on this in a candid conversation between Courtney and Mireille in this recent webinar.)

As the conference sessions run concurrently, these are but a few highlights from the event. Now if only I could run myself through a 3D printer so I could be in ALL of the sessions! (You can however read a blog from the vantage point of my colleague Glenn Gammer).

We thank everyone who joined us in Barcelona and say special thanks to all of our customers and partners who presented success stories and shared their experiences. It was a great learning experience for our users as well as BioClinica product development, project management and other team members. We hope to keep the conversation going. Tell us what is working as well as what we can do better to make your clinical trials the best they can be.

All of our customers are encouraged to attend the annual BioClinica User Conferences at your nearest location. Besides Europe, we hold two in the U.S., one on the West Coast and our upcoming Global User Conference in Orlando, May 5th and 6th, 2015. We look forward to seeing everyone there for more great conversation and a terrific time under sunny Florida skies!

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Overcoming Barriers to Risk Based Monitoring

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