01 Aug 2014

Taming Clinical Trial Complexity

by Gregory Simpson

How many data points are collected in the average clinical trial and how much is actually included in final trial reports? What can be done about the increasing complexity of clinical trials? Watch this quick video for answers to these questions and more. (more…)

29 Jul 2014

Risk-Based Monitoring: How to Know if It’s Right for Your Study

by Laurie Falkin

TransCelerate partnered with Medidata for robust data assets to answer important risk-based monitoring ​questions. View this video infographic to see research on the value of risk-based monitoring and the important questions to be answered. (more…)

25 Jul 2014

The Evolving Role of the Clinical Research Associate

by Geeks Talk Clinical

What are the near-term and long-term ways the role of the clinical research associate will change, when it comes to monitoring sites? (more…)

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…)

Taming Clinical Trial Complexity

http://youtu.be/Em4UgfO6r0M How ...

Risk-Based Monitoring: How to Know ...

http://youtu.be/HyLMwRFYAqo Tran ...

The Evolving Role of the Clinical R ...

http://youtu.be/M4Vucx7kUJU What ...

The Role of the Patient in Clinical ...

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

Paper Patient-Reported Outcomes? Re ...

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

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...