18 Dec 2014

Addressing the Patient Recruitment Challenge in a Disruptive Way

by Tom Dorsett

ePatientFinder is revolutionizing patient engagement by bringing parties together to solve the recruitment challenge. They’re partnering directly with physicians so that patients can learn about treatment options from their trusted doctors. But that’s not all this innovative company is bringing to the clinical trials landscape. (more…)

10 Dec 2014

Risk-Based Monitoring Updates: TransCelerate, the Value of SDV, Global Monitoring Trends and More

by Geeks Talk Clinical

A risk-based monitoring (RBM) overview and 2014 updates by industry experts Lori Convy (Sanofi), Scott Freedman (MonitorForHire.com) and Kyle Given (Medidata). (more…)

04 Dec 2014

How Life Sciences and Health Technologies are Changing the NYC Story with EpiBone CEO and TED Senior Fellow Nina Tandon

by Nina Tandon

Nina Tandon is the CEO of EpiBone, a NYC start-up and the first company working on growing personalized human bones for reconstructive surgery, by using patients’ own stems cells and tissues. (more…)

01 Dec 2014

Optimizing Clinical Trial Supplies

by Anne Kulak

iStock_000047465614LargeWith the annual expenditures for clinical supplies being 40% or more of a sponsor’s R&D budget, efficiently managing clinical trial supplies is a critical component of any supplies-dependent clinical trial. The optimal plan is one that strikes a balance between trial demand, trial budget and available stock and—when successful—decreases wasted supplies, lowers costs, ensures supplies reach the sites on time and in the correct quantities, and ultimately accelerates the speed to market.

The first step in developing a balanced clinical supply strategy is to determine which factors most influence the supply chain. Considerations such as supply cost and availability, technology and therapeutic area trends, often are very significant. With an understanding of these factors in hand, the details of the clinical supply strategy can be put in place. A successful supply plan includes things such as a packaging and shipping plan as well as distribution logistics. (more…)

25 Nov 2014

Talking Clinical Trials of the Future with Nina Tandon – EpiBone CEO and TED Senior Fellow and Speaker

by Nina Tandon

Nina Tandon has been described as a proficient multitasker. After receiving her biomedical engineering PhD from Columbia, she began working at their stem cells and tissue engineering lab on creating a living heart for transplants. She’s now the co-founder and CEO of EpiBone, the first company working to grow living human bones for skeletal reconstruction. (more…)

18 Nov 2014

Product Management is Still a Game of Telephone: Focus on Goals

by Dhruv Vasishtha

CommunicationOverloadAs organizations have moved towards agile methodology, many point to broken lines of communication as the pain point they’re addressing. We’ve heard it before: person A makes a request of person B who passes that on to person C and so on, leading to stilted and myopic collaboration.

But even though product managers are bringing UX, Engineering, and QA into the planning process earlier on, they are still playing one big game of telephone, trying to keep communication consistent. As we move from the planning phase to actual development, the mHealth team at Medidata is using some new processes to overcome the challenges of maintaining a coherent vision for our upcoming release. (more…)

12 Nov 2014

Perspectives, Concerns and Myths… Talking Risk-Based Monitoring with Investigative Sites

by Geeks Talk Clinical

When it comes to the risk-based monitoring (RBM) conversation, the investigative site personnel is such an important stakeholder. Yet for the most part, they’ve been out of the RBM loop. We haven’t always engaged with sites early on, helping them understand the language and what RBM actually means. (more…)

06 Nov 2014

Paper Patient-Reported Outcomes: Golden No More

by David McNierney

New Model for Electronic Patient-Reported Outcomes (ePRO)“We must do all that we can to make patient-reported outcome assessment feasible and credible. If we fail in our task we will have left out the heart of all healthcare research: the patient.”

This quote, from Sloan and colleagues, is a powerful reminder of the importance of patient-reported outcomes (PROs), particularly as the chorus calling for patient-centered research grows.

The delivery mechanism is inextricably linked to PROs’ feasibility and credibility. Paper, in addition to being the original mode, has long been the gold standard for PRO data capture, but times have changed and the credibility of paper has never been lower. (more…)

04 Nov 2014

Olympic Moments at the European Medidata Symposium in Lausanne, Switzerland

by Ross Rothmeier

#MedidataSYM_OlymMuse-FieldOver 200 Medida-thaletes convened in the Olympic capital of Lausanne, Switzerland at the aptly named Beaulieu (“beautiful place”) Congress Center October 14-16 to engage, collaborate and innovate in the spirit of transforming clinical development.

Nestlé graciously hosted the event and their head of biostatics and clinical data management Stephane Collet set the stage by sharing some insight to the company’s work in clinical research. Walking in to the room, most of us appreciated their contributions to the world of chocolate, but their commitment and depth of work in nutraceuticals is even more impressive and of course powered by the Medidata Clinical Cloud! (more…)

28 Oct 2014

Metrics, Metrics, Metrics… What’s Important to Clinical Trial Sites?

by Lindy Jones

Quintiles’ global head of integrated site services Lindy Jones was a featured speaker at the recent Site Solutions Summit. Hosted by the Society for Clinical Research Sites (SCRS), the summit focuses on clinical research site performance and brings together executives from site, sponsor, CRO and supplier organizations. (more…)

24 Oct 2014

Adaptive Trials Are Here… Are You Ready?

by Anne Kulak

White clock with words Time to Adapt on its faceAre you ready for adaptive trials? This was the question posed by Medidata‘s Evan Hahn and Wade Wirta at the Interactive Response Technologies for Clinical Trials (IRT) 2014 conference in Philadelphia. Evan and Wade presented on leveraging IRT to execute successful adaptive clinical trials.

Adaptive study and statistical designs have been utilized in the industry in the past. However, the feasibility for conducting more complex studies and leveraging the power of adaptive designs at scale has only recently been possible, as IRT and other technology has better enabled its implementation. And although adaptive methodology is encouraged by the FDA, particularly for exploratory trials, there is still reluctance to invest in these designs. This is due to continued concerns around the operational challenges and technology integration that is required for successful implementation. (more…)

22 Oct 2014

TransCelerate and Medidata Explore SDV Effectiveness in Upcoming Webinar

by Geeks Talk Clinical

DataIt’s no secret that clinical trial complexity and drug development costs are at an all-time high. With more than 30 percent of trial budgets allocated to site monitoring costs—and more than half of that being spent on source document verification (SDV) activities¹—the idea of implementing a risk-based monitoring (RBM) program to rid ourselves of the traditional 100-percent-SDV approach has the life sciences industry buzzing.

As long-time proponents of RBM methodologies, we recently teamed up with TransCelerate BioPharma Inc. on a joint initiative to assess the relative effectiveness of SDV on overall clinical data quality, providing TransCelerate with robust data analytics to help determine: (more…)

Addressing the Patient Recruitment ...

http://youtu.be/Y_WQ2mGxOqg ePat ...

Risk-Based Monitoring Updates: Tra ...

http://youtu.be/_dSiVnjNIyU A ri ...

How Life Sciences and Health Techno ...

http://youtu.be/VHiahhxHBeE Nina ...

Optimizing Clinical Trial Supplies

With the annual expenditures for cl ...

Talking Clinical Trials of the Futu ...

http://youtu.be/8h8o9igZmxA Nina ...

Joe on Mobile Patient Data Capture — A Huge Step Forward
Nailed it.

john anstey on Ni Hao from Shanghai! 上海的你好
Great article. Exciting times ahead. I believe that China will award us the rare opportunity of applying our platform as...

Kajol on Data Management, Safety Systems and How Technology Can Improve Clinical Development Processes
It is a nice blog. It contain good information on clinical data management

Laurie Meehan on Providing Clarity on the Definitions of Source Data Verification (SDV) and Source Data Review (SDR)
Agreed - a new term would have been preferable, but we of course have the benefit of hindsight. We’re...

Steve Young on Providing Clarity on the Definitions of Source Data Verification (SDV) and Source Data Review (SDR)
Thanks Laurie for your thoughts. I agree with your concern regarding the "re-definition" of SDV by TransCelerate - particularly...