Disruptive innovation. Sure, the term is a buzzword. But maybe it’s more than that. As someone who’s long followed the wisdom of Clay Christensen, I have a healthy respect for the concept of “innovation.” But lately it doesn’t seem to go out without its new BFF, “disruptive.” We at Medidata talk about it a lot. And we are certainly doing a lot to disrupt the broken processes and technologies of clinical research. But earlier this week, I decided to see what the rest of the industry had to say about things. As an attendee at the first annual Disruptive Innovation in Clinical Trials Europe conference, held 4-5 March in London, I heard from a bevy of senior decision makers and trend-shifters in clinical R&D about what THEY thought disruptive innovation in clinical trials looked like. (more…)
In a previous post, we asked “In Clinical Trials, Does the Patient Experience Matter?” While an interesting rhetorical question, the more strategic question is: “What role should patients play in clinical development going forward?”
Clinical R&D in its current state is not sustainable. The good news, however, is new technology, as it often does, enables a fundamental rethinking of processes, relationships and priorities. The enabling technology today is mobility and mhealth. (more…)
In this conclusion of our two-part video series, Medidata’s Marcus Thornton and Jessica Dolfi continue their recap of the recent SCOPE Summit. Marcus and Jessica discuss reporting challenges for organizations, including sponsors, CROs and universities. Sites are looking for more information on the Sunshine Act, so there’s a need to educate those involved. (more…)
Medidata’s Marcus Thornton and Jessica Dolfi attended the recent SCOPE Summit in Florida, focused on clinical operations executives. In part one of our two-part event recap, Marcus and Jessica discuss study site selection and the site startup process, clinical integrations, as well as risk-based monitoring. Jessica also shares some insight on the Sunshine Act and how the industry is now in action-mode, as the reporting requirements are coming up in the next few weeks. (more…)
Medidata Solutions and INC Research co-hosted a seminar on reducing site monitoring costs, sharing major considerations and best practices on implementing a risk-based monitoring (RBM) program. In this final video with Medidata presenters Steve Young, Philip Coran and Mike Petrarca, Steve discusses how cycle time from subject visit to data entry is important for effective RBM, and how we should urge sites to enter visit data quickly. (more…)
With the industry shifting to a risk-based monitoring model, it is probably time to think about what this means for investigative sites and its time to think about the role clinical research associates (CRAs) play. The original assignment of our CRAs was to simply “monitor” their assigned sites. This term, defined as “to observe and check the progress or quality over a period of time; keep under systematic review” tends to leave sites feeling like they’re being watched for negative behavior, which is then recorded by the CRA in a report. In school it was the hall monitor. In our homes we install air quality monitors to detect levels of carbon monoxide. (more…)
Watch the conclusion of our two-part video interview with Laura Zupko who heads up the clinical IT function at GlaxoSmithKline. In part two of this video interview, Laura chats with Medidata’s Igor Altman about the potential for evolving cross-industry initiatives that focus on integrating, sharing and utilizing sponsor data. They also discuss the need to build an information and systems blueprint for sharing data across the clinical landscape. (more…)
Medidata Solutions and INC Research recently co-hosted a seminar on reducing site monitoring costs, sharing major considerations and best practices on implementing a risk-based monitoring program. The seminar covered how to interpret the newest updates from regulatory agencies; implementing a total data quality plan, including assessing risk up-front; measuring success; and leveraging technology to adopt strategic monitoring and help streamline processes. (more…)
Laura Zupko currently heads up the clinical IT function at GlaxoSmithKline. We caught up with Laura at the European Medidata User Group (E-MUG) conference in Italy where she presented, “R&D Alignment and Optimization through Technology Innovation.” In part one of this two-part video interview, Laura chats with Medidata’s Igor Altman about the benefits of platform integration, the need for transparency and how better managing and understanding clinical and operational data can help drive efficiencies. (more…)
Everyone’s talking about risk-based monitoring, but few are actually doing it so far. The below graph illustrates this slow adoption trend over the last six years, depicting source document verification (SDV) coverage rate—the percentage of site-entered electronic case report form (eCRF) data targeted for SDV. It’s using operational metric data compiled from the Medidata Insights metric warehouse, comprising data from over 6,000 studies. SDV coverage has steadily decreased over that period, but only modestly from the mid-90 percent range in 2008 down to the mid-80 percent range over the past couple of years. (more…)
Last month, Medidata Solutions and INC Research co-hosted a seminar on reducing site monitoring costs, sharing major considerations and best practices on implementing a risk-based monitoring program. (more…)
Miguel Valenzuela is head of business intelligence and oversight at Bayer HealthCare’s global clinical development organization, and Bayer’s risk-based monitoring (RBM) implementation leader. He presented during the 2013 European Medidata user Group (E-MUG) conference on the framework and process of implementing an RBM program, as well as the challenges and evaluation factors. Miguel also participated in the E-MUG site management and monitoring panel discussion on the implications of the Transcelerate risk-based monitoring position paper. (more…)
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SCDM: Risk-Based Monitoring and the Implications to Data Management
I absolutely agree with this approach. I think Clinical Data Manager are the one with technical skills and behaviors to...
How Technology and Partnerships are Shaping the Evolving CRO Market (Part 1)
Awesome job guys!!
What a New Proof-of Concept Might Mean for Clinical Trials of the Future (Part 2)
These thoughts on RCT Phase I with continual patient data entry, often without site visits or supervision, may be Ok...
Health Care Innovation Takes Center Stage at Health 2.0
thanks for sharing.. it sounds really good in this article... this providing fund to EHR ..good to see...
Black Hat is Black Gold for Medidata
"With the right tools, a hacker can capture the login credentials of a user and gain “front-door” access to an...
CDISC and Industry Standards
Late Phase Development
Patients and Sites
Planning and Budgeting
Randomization and Trial Supply Management
Safety Data Capture
Study and Protocol Design