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eClinical Lessons Learned

eClinical Insights Shared at the BioClinica Global User Conference

Part 2 of 2

In my last blog, I shared risk-based monitoring (RBM) lessons learned and RBM insights from the  BioClinica 5th Annual BioClinica Global User Conference held in May in Orlando, Florida.  Here is a recap of other eClinical sessions I had the pleasure of attending.

MedDRA decoded

In the MedDRA session, Dr. David Richardson discussed the varying systems and organ classifications currently in place. We heard 40 percent of the terms are found in more than one SOC. PT, HLGT and HLT, for instance, are all found in multiple SOCs. This begs the question, "What are you to do?” Dr. Richardson advised that with coding we must be certain we've looked in all of the right places. The main presentation, he explained, is by primary SOC while the secondary SOCs are used for alternate views and data presentation. He cautioned, "You do not want a regulator to understand your data better than you.”

Collaboration, secrets to success

Next I attended a session about strategic products and embedded resources presented by Chris Barschick, Clinical Affairs Director, Johnson & Johnson Vision Care, and Angela Faircloth, Program Manager, BioClinica, who discussed key elements of our successful 15-year partnership.

With New Jersey, Pennsylvania and New York home to 14 of the world's largest pharma companies, Chris pointed out that Jacksonville, Florida is not exactly a hotbed for clinical research.  With study designers, electronic data capture (EDC) architects, data managers and others needed, what's a clinical operations manager to do? Rather than moving to a research corridor, the answer was to embed some resources and outsource others to make Jacksonville a place for research. He talked about what makes BioClinica a great clinical trial partner, explaining how our embedded resources are solely focused on their success and that our dedicated personnel know their studies as well as they do.

For organizations seeking such strategic partners, Chris advised sitting down together and hammering out agreed upon KPIs and a schedule for regular governance covering both tactical and strategic elements. He cited a willingness of both parties to share business strategies and to embrace each other's success as keys to a healthy and rewarding partnership. Angela, based in Jacksonville, talked about staying connected within a large clinical universe. She gave a brief overview of BioClinica systems being used, including CTMS for study tracking, operations management and metrics, as well as EDC and IRT and how these systems create an eClinical ecosystem where everything interacts to support the clinical research program.

Special thanks to BioClinica users…everywhere

As the conference sessions ran concurrently, these are but a few highlights from the event. We thank everyone who joined us in Orlando and say special thanks to all of our customers and partners who presented success stories and shared their experiences. It was also a great forum for our product engineers and professional services team to learn about our customers' emerging needs. We hope all of our attendees found it to be a useful learning experience and enjoyable event. Until our next conference, we welcome your feedback on what is working, as well as what we can do better to make your clinical trials the best they can be.

Check our Events page to see where we are next. If you would like to schedule a special meeting, Contact Us. We'd love to hear from you and hope to see you at the next year's User conference.

Special thanks to everyone who participated in this year's User Conference, and special thanks to BioClinica users everywhere!

Category: 

Risk-Based Monitoring Technology

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