22 Jan 2015

mHealth in Clinical Trials: Instrumenting the Patient with Sensors, Wearables and Apps

by David McNierney

By providing study volunteers with mHealth devices, including smartphones and wearable technology, trials can access virtually unlimited real world data yielding myriad benefits, both for industry and us all. The technology is ready now. (more…)

16 Jan 2015

How Do Medical Device Companies View Risk-Based Monitoring and Does It Differ from Pharmaceuticals?

by Nurcan Coskun

When it comes to risk-based monitoring (RBM) in clinical research, how are studies conducted by medical device companies different from pharma studies? Medtronic International’s Nurcan Coskun shares her thoughts, in the first of this two-part video series. (more…)

08 Jan 2015

Revolutionionizing the Way Physicians Connect Patients to Life-Changing Treatments

by Tom Dorsett

ePatientFinder makes it possible for physicians to learn about new, life-changing treatments for their patients. And that’s not all they’re doing to revolutionize clinical trials. In this conclusion of our video chat with president and CEO Tom Dorsett, we hear about ePatientFinder’s work with electronic health records (EHR) vendors and additional services they’re beginning to offer.

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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…)

mHealth in Clinical Trials: Instrum ...

By providing study volunteers w ...

How Do Medical Device Companies Vie ...

When it comes to risk-based mon ...

Revolutionionizing the Way Physicia ...

ePatientFinder makes it possible ...

Addressing the Patient Recruitment ...

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

Risk-Based Monitoring Updates: Tra ...

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

Sun on How Can We Accelerate Innovation with Standardization? Thoughts from the CDISC European Interchange
Kudos! What a neat way of thkiinng about it.

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...