23 Jul 2014

The Role of the Patient in Clinical Trials

by Tushar Jain

A recent survey showed that 51 percent of patients want to learn about clinical trials from their physician. Yet only 20 percent of patients actually do, with many getting their information via the Internet or through mass media advertising. (more…)

21 Jul 2014

Paper Patient-Reported Outcomes? Really?!?

by David McNierney

Why in this day and age, with people connected 24×7 via their smartphones, do studies still use paper to capture patient-reported outcomes (PROs)? (more…)

16 Jul 2014

TransCelerate Partnered with Medidata to Answer Important Risk-Based Monitoring Questions

by Kyle Given

In this video, Kyle Given discusses Medidata’s ongoing support for TransCelerate’s risk-based monitoring (RBM) initiative. Kyle reviews the questions related to the impact of source document verification (SDV) on overall data quality that this analysis is trying to answer. The results will be issued by TransCelerate as part of an upcoming manuscript. (more…)

15 Jul 2014

Computer System Validation in the Cloud: Cloud is Here Today and Here to Stay

by Fran Nolan

binary codeAt this year’s annual Drug Information Association (DIA) meeting, I again had the pleasure of chairing another exciting and well-received session on computer validation and auditing. We discussed how organizations are benefiting from novel approaches to the development, validation and deployment of systems in a regulated environment. We offered real examples of how practices such as agile software development, SaaS models, cloud deployment and alternative supplier auditing approaches are being used today to great effect. (more…)

14 Jul 2014

What are the Key Cost Drivers in Clinical Trials?

by Geeks Talk Clinical

As the life science industry evolves, we continue to look for ways to improve technology and reduce the costs of clinical trials, to bring better treatments to patients. (more…)

09 Jul 2014

What Every Clinical Research Associate Wants to Know About Risk-Based Monitoring

by Geeks Talk Clinical

The question of whether or not the role of the clinical research associate (CRA) will become obsolete has been coming up in many industry discussions. Such was the case at the Drug Information Association (DIA) Risk-Based Monitoring (RBM) Symposium. In this video, presenters Rita Purvis, Dermot Kenny and Marcus Thornton share their thoughts on the topic. (more…)

07 Jul 2014

Tracking Drug Development Cost Savings Through Risk-Based Monitoring

by Kyle Given

Drug development costs continue to rise and the life sciences industry is under greater pressure to increase efficiency and operating speed. (more…)

27 Jun 2014

Using Big Data Techniques to Integrate Clinical Study Data with Genomic Data for Real-World Analytics

by Geeks Talk Clinical

With all of the large amounts of different electronic data now available, our industry is changing so fast. The challenge is converging all of that data, aggregating it and trying to find meaningful insight into the information, to speed up clinical development and improve patient care. (more…)

24 Jun 2014

Clinical Development Outsourcing Practices — Staying On the Radar

by Alan Eggleston

RadarI was recently lucky enough to attend the Pharmaceutical Contract Management Group’s (PCMG) 10th Annual Conference in Cascais, Portugal along with Medidata colleagues Richard Young and Karim Herbal. PCMG was formed in 1994 by contract managers as a forum for sharing information on best practices in managing their increasing reliance on external providers. To that end, they have maintained a fixed pharma:vendor ratio to avoid overt pressure and foster an environment where people can genuinely interact without feeling “sold to.” And, despite the fact that any salesman will tell you that it’s a target-rich environment, they have largely managed it.

This year’s conference theme was “20 Years of Outsourcing: Then, Now & the Future.” Inevitably, in any annual conference, it is difficult to be innovative so it’s probably fair to say that many of the topics covered (feasibility, contracting with investigator sites, regulatory oversight) were restatements of relatively well-established positions. (more…)

18 Jun 2014

DIA Educational Workshop: Building a Site Budget from the Ground Floor

by Lindsey Sarno

Site budgets are an increasingly complex and important part of the overall clinical budget. A well-designed site budget can ensure regulatory compliance and help you achieve quicker site start-up. Medidata training specialist Lindsey Sarno shared best practices for building a clinical site budget at the 50th Annual Drug Information Association (DIA) meeting in San Diego. Watch this video recap to hear Lindsey’s takeaways.


16 Jun 2014

DIA Explores Risk-Based Monitoring and the Evolving Role of Clinical Research Associates

by Laurie Falkin

The Drug Information Association (DIA) recently announced a focus on risk-based monitoring (RBM) discussions at this year’s 50th annual meeting. The first featured session in their announcement is the “Risk-Based Monitoring Symposium,” chaired by our own Marcus Thornton. Medidata, inVentiv Health, and ICON will discuss the next generation clinical research associate (CRA). They’ll also dig into how RBM will affect the CRA’s roles and responsibilities. RBM is no longer an innovative theory but a real-world practice. (more…)

The Role of the Patient in Clinical ...

http://youtu.be/1YZzyL3hlIw A re ...

Paper Patient-Reported Outcomes? Re ...

http://youtu.be/lamPYO7zpu8 Why ...

TransCelerate Partnered with Medida ...

http://youtu.be/lxJnXI27tnE In t ...

Computer System Validation in the C ...

At this year’s annual Drug Inform ...

What are the Key Cost Drivers in Cl ...

http://youtu.be/UekH8pLf_rQ As t ...

Melanie on SCDM: Risk-Based Monitoring and the Implications to Data Management
I absolutely agree with this approach. I think Clinical Data Manager are the one with technical skills and behaviors to...

Demond on How Technology and Partnerships are Shaping the Evolving CRO Market (Part 1)
Awesome job guys!!

Paul Hwang on What a New Proof-of Concept Might Mean for Clinical Trials of the Future (Part 2)
These thoughts on RCT Phase I with continual patient data entry, often without site visits or supervision, may be Ok...

healthcare payer bpo on Health Care Innovation Takes Center Stage at Health 2.0
thanks for sharing.. it sounds really good in this article... this providing fund to EHR ..good to see...

CFH on Black Hat is Black Gold for Medidata
"With the right tools, a hacker can capture the login credentials of a user and gain “front-door” access to an...