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…)
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…)
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…)
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…)
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…)
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…)
At 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…)
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…)
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…)
Drug development costs continue to rise and the life sciences industry is under greater pressure to increase efficiency and operating speed. (more…)
Using Big Data Techniques to Integrate Clinical Study Data with Genomic Data for Real-World Analytics
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…)
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 ...
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...
How Technology and Partnerships are Shaping the Evolving CRO Market (Part 1)
Awesome job guys!!
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...
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...
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...
Clinical Data Analytics
Clinical Study Design
Clinical Trial Budgeting
Clinical Trial Management
Clinical Trial Phases
Cloud Computing, SaaS and PaaS
ePRO and mHealth
FDA and Regulatory Affairs
Innovation and Entrepreneurship
Interoperability and eClinical
Randomization and Clinical Trial Supply
Site Engagement and Monitoring
Technology and Agile Development