Medidata Blog

Scoping Out Study Planning Challenges

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A few weeks ago, I was asked to leave frigid New York City for the sub-tropical climes of Miami for a few days during the week beginning February 4. Obviously, I struggled mightily with the decision. But the level of dialogue to be had at the SCOPE Summit at the Miami Hyatt Regency was compelling. So, I agreed. Frankly, I could use the sunlight. SCOPE Summit is a series of meetings, presentations and workshops organized to explore the challenges—and solutions to those challenges—for clinical operations executives at clinical research organizations. As Medidata has expanded beyond electronic data capture, it has become much more important to understand the clinical operations organization and the role that technology, data and process plays in their day-to-day lives. Our presence at SCOPE is crucial to that mission. One area critical for today’s clinical operations executive is the concept of study planning, which lies at the intersection of both financial and clinical planning. It includes study and protocol design, financial budgeting, simulation and more. Joining the rest of the clinical operations community at SCOPE is a great opportunity to discuss the challenges and opportunities in the study planning process. I will address the study design portion during my presentation, For Optimized Study Design, Three’s Company, taking place during the “Clinical Trial Forecasting, Budgeting, and Project Management” track on Thursday, February 7 at 1:30 p.m. I will also host a roundtable to discuss the role study planning plays in managing risk in clinical trials on Wednesday, February 6 at 4:30 p.m. If you’ll be in Miami, please join me for these stimulating discussions! *For more on the SCOPE Summit, check out our recent blog post by Medidata's Jessica Dolfi, It's Not the Heat, It's the "Sunshine." Guest blogger Igor Altman is a project manager at Medidata Solutions and subject matter expert. You can reach Igor by email.

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