27 Feb 2015

Rare Disease Week on Capitol Hill

by Steve Smith

FrancisCollins__NlPatient advocates convened on Capitol Hill Feb 23-27 for Rare Disease Week. I was honored to meet with fellow advocates, orphan drug company representatives and members of Congress who we urged to support the new draft 21st Century Cures legislation. This draft discussion document was just issued in January by the House Energy and Commerce Committee. The essence of that proposed legislation is to put patients in the center of drug development, to modernize the process by which we regulate drug development and to free data from its silos by creating a 21st Century Data Infrastructure, among other transformative changes needed in the “path to cures.” (more…)

20 Feb 2015

A Conversation on US-East Asia Pharma Collaboration

by Bryan Spielman

IMG_1671Last week, I attended a conference on US-East Asia pharma collaboration at the Yale Club of New York City. Hosted by the New York Pharma Forum and the New York Health Forum, both organizations focus on creating and furthering opportunities for global pharmaceutical industry collaboration and development. I was delighted to join panelists Les Funtleyder, portfolio manager at Esquared Asset Management, and Debra Yu, managing director at Labrador Advisors, for the discussion, “Fitting into the Ecosystem: New Sustainable Strategies of Collaboration.” We talked about building successful partnerships among pharma and biotech companies from China, Korea, Japan and the US. (more…)

12 Feb 2015

Transforming Clinical Development One Study at a Time

by Geeks Talk Clinical

The life science industry is under pressure. As key patents are expiring, pharma and biotech companies are challenged to bring new and better treatments to patients. Clinical trials are vital for proving safety and efficacy – but they’re long, complicated and expensive. (more…)

06 Feb 2015

The Future of Clinical Trials… A Look Back at Symposium Europe with Service Partner Wincere

by Himanshu Kansara

Video interview with Himanshu Kinsara, managing director at Wincere, on his key takeaways from our Medidata Symposium Europe. Having attended his seventh user group meeting late last year, Himanshu discusses what keeps him coming back, why he thinks risk-based monitoring is the future of clinical trials, and new initiatives at Wincere. (more…)

30 Jan 2015

Collecting Clinical Data, RBM, Study Design and More… Medical Device and Pharma Perspectives

by Nurcan Coskun

How are clinical studies conducted by medical device companies different from pharma studies? Is the way clinical data is collected or risk-based monitoring and critical processes conducted similar? Medtronic International’s Nurcan Coskun shares her thoughts, in this video conclusion.

Watch Part 1 of our video interview with Medtronic International’s Nurcan Coskun. (more…)

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.


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…)

Rare Disease Week on Capitol Hill

Patient advocates convened on Capit ...

A Conversation on US-East Asia Phar ...

Last week, I attended a conference ...

Transforming Clinical Development ...

The life science industry is un ...

The Future of Clinical Trials... A ...

Video interview with Himanshu K ...

Collecting Clinical Data, RBM, Stud ...

How are clinical studies conduc ...

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...