01 Jul 2015

The Value Proposition for mHealth in Clinical Trials

by Geeks Talk Clinical

We had a chance to catch up with Julian Jenkins, the head of GlaxoSmithKline’s digital platform performance unit, to talk about the opportunities and risks for mHealth tools in clinical trials, and it was great to hear more about GSK’s interest in this space.

We chatted with Julian on the sidelines of the DIA Annual Meeting, and he shared his thoughts on how mHealth tools can generate value for companies and how to overcome perceived barriers to adoption.

Our own Phil Coran, Medidata’s senior director of quality and regulatory affairs, chaired a DIA panel with Julian, Pfizer’s Craig Lipset, and Philip Kronstein from the Office of Scientific Investigations at FDA’s Center for Drug Evaluation and Research. FDA’s message was clear: The agency wants to be partners in innovation with pharma and is very open to conversations about incorporating mHealth into clinical trials. We look forward to moving the conversation forward.

25 Jun 2015

Five Considerations For Wearable Devices In Clinical Trials

by Geeks Talk Clinical

mHealth Wearables and the Internet of ThingsCraig Lipset leads Pfizer’s clinical innovation department for worldwide R&D, and in his role he helps shape new practices for clinical development at Pfizer, which includes exploring the use of wearable devices and sensors in clinical trials. Wearable devices receive plenty of attention in the consumer setting, and they are now receiving increased consideration in the clinical setting as well. (more…)

10 Jun 2015

The Data-driven Protocol Design

by Geeks Talk Clinical

Dia 2015 #MOVEfwd

Dave Gemzik, Medidata’s Principal for Strategic Consulting Services, will speak at the DIA Annual Meeting in Washington, DC about creating high quality clinical trial protocols through a data-driven approach. He is speaking at a session focused on improving the effectiveness of medical writing, and Dave’s presentation will help illustrate the value of arming medical writers with a structured protocol design and data and how doing so can optimize study designs to impact clinical development. We provide here a snapshot of some of the points he will address at DIA.


04 Jun 2015

Finding The Right Drug For The Right Person At The Right Time With Companion Diagnostics

by Barbara Elashoff

iStock_000003715444LargeThe term “personalized medicine” is frequently added to the discussions of how to improve health care, and a new breed of medical devices called companion diagnostics are much of the backbone for this new approach to personalized care. (more…)

28 May 2015

The Promise Of The Digital Health Revolution For Clinical Trials

by Geeks Talk Clinical


WatchThe global head of research at Sanofi put a policy in place to attach a digital health strategy concept to each molecule that goes through the pharmaceutical company’s pipeline.

The fact that a digital strategy is reaching into the depths of the largest pharma companies is extremely encouraging for the continued evolution of clinical development, says Donald Jones, the chief digital officer at Scripps Translational Science Institute, which serves as the world’s first clinical trials center focused exclusively on digital medicine.


22 May 2015

Eli Lilly And Company Has A Plan To Speed Clinical Development In Emerging Markets

by Geeks Talk Clinical

Eli Lilly

Chito Zulueta was appointed president of emerging markets at Eli Lilly & Co. in 2014. He has held various roles at Lilly, most recently as president of Eli Lilly Japan. He spoke with us about the company’s clinical development strategy for emerging markets like China and South Korea.


06 May 2015

Eisai Chief Medical Officer Stewart Geary On Clinical Trial Complexity

by Geeks Talk Clinical

Stewart Geary smile

Clinical trial costs are increasing, and there’s no clear sign that these increased costs are improving the clinical trials process.


The Value Proposition for mHealth i ...

We had a chance to catch up with ...

Five Considerations For Wearable De ...

Craig Lipset leads Pfizer’s clini ...

How Does Risk-based Monitoring Impa ...

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The Data-driven Protocol Design

Dave Gemzik, Medidata’s Princ ...

Finding The Right Drug For The Righ ...

The term “personalized medicine ...

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