26 Mar 2015

The Quality by Design Aspects of Risk-Based Monitoring — SDV, SDR and the Role of the CRA

by Geeks Talk Clinical

Part of laying the foundation for a successful risk-based monitoring (RBM) program is training clinical research associates (CRAs) on what data needs to be reviewed on site, and how much of it. (more…)

19 Mar 2015

One Patient’s Clinical Trial Experience: “It’s Not Just a Document. It’s a Life.”

by Geeks Talk Clinical

T.J. Sharpe is a cancer survivor turned patient advocate. While trying to enroll in a research trial that could essentially save his life, T.J.’s clinical trial agreement just sat on a lawyers desk  waiting to be executed. But as a Stage 4 melanoma cancer patient, T.J. didn’t have much time. His only option was to advocate on his own, in order to get through all of the red tape. (more…)

12 Mar 2015

What Advocates Said to Congress During Rare Disease Week on the Hill

by Steve Smith

SteveSmithRare Disease Week on Capitol Hill, February 23-27, 2015

Several hundred new rare disease treatments could be approved in just a few years; previously, that has taken decades.

Elevator Pitch from Rare Disease Advocates to Capitol Hill

Helpful Legislation Proposed in 21st Century Cures Draft

In late January, the U.S. House of Representatives Energy and Commerce Committee issued its draft discussion document. The line items are proposed to become laws that could transform drug research, development, and delivery. Advocates studied this legislation and then went to Capitol Hill last week and met with legislators. (more…)

06 Mar 2015

Translating Quality and Risk Assessment for Risk-Based Monitoring at SCOPE Summit

by Kyle Given

This year, SCOPE Summit hosted the Cambridge Healthtech Institute’s inaugural conference “From QbD and Risk Assessment to Risk-Based Monitoring (RBM) — Laying the Foundation.” Medidata’s Kyle Given moderated one of the sessions, featuring Boehringer Ingelheim’s Andy Lawton and CRA Consultant Mary Mills. In this video recap, Kyle shares his takeaways and why he believes that RBM is the wave of the future when it comes to clinical trials’ execution. (more…)

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.


The Quality by Design Aspects of Ri ...

Part of laying the foundation f ...

One Patient's Clinical Trial Experi ...

T.J. Sharpe is a cancer survivo ...

What Advocates Said to Congress Dur ...

Rare Disease Week on Capitol Hill, ...

Translating Quality and Risk Assess ...

This year, SCOPE Summit hosted ...

Rare Disease Week on Capitol Hill

Patient advocates convened on Capit ...

Khrystal Davis on What Advocates Said to Congress During Rare Disease Week on the Hill
Great post Steve. I am mother to Hunter, a RARE terminal ill three year old with SMA Type 1. I'm...

Penelope Manasco on Are Your Data Cleaning Cycle Times Out of Control?
Steve, I'm confused about this graph. You say that time from visit to query close is in the 30 day...

Vijay on Amgen Team Discuss Study Design, Data Monitoring and Clinical Integrations at 2012 A-MUG
Every visit we are treated by freldniy staff and doctors! They remember us personally and are very courteous with every...

Yayas on If They Cooperate, They Will Cure
17:10 Most of the current oscouurted life sciences work is Oracle-centric, and Oracle has been doing a good...

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