Getting effective treatments to patients more quickly is an industry goal and especially important within oncology studies. With the CDISC standardization of Study Data Tabulation Model (SDTM) structures for oncology studies and flexibility of EDC systems, it seems there would be a simple way to get data collected and easily reviewable to shorten study timelines. However, specialty treatments require precise data reporting and multiple amendments, coupled with potentially lower protocol compliance. And overworked study coordinators can result in a lack of compliance of data entry. (more…)
Medidata Symposium — Thought Leaders and Industry Peers Come Together to Engage, Collaborate and Innovate
I recently attended the European Medidata User Group (E-MUG) 2013 meeting, in Florence, and am looking forward to this year’s reinvented annual meeting in San Francisco, April 23-25, renamed the Medidata Symposium 2014 – Americas.
Over the years, I’ve appreciated the efforts that Medidata has made to bring the user community together, to a degree which I have not seen from other technology and service organizations in our industry. It is a great opportunity to reunite with former colleagues and make new connections with professionals from pharma, biotech, academia, contract research organizations (CROs) and other technology providers, while sharing experiences and generating new ideas about clinical trial conduct. (more…)
Many clinical R&D experts have expressed concern regarding quality and performance of investigative sites in economically emerging global regions, due to relative lack of GCP experience as well as language and cultural barriers. The concern has risen to the level of questioning whether risk-based monitoring can be safely applied to studies conducted in emerging regions. (more…)
A team of Medidata engineers recently developed a mobile app prototype—Medidata Engage—that creates new connections between patients, physicians and sponsors. The prototype was named winner of the recent Patient Engagement App Challenge (large organization category), for its potential to positively transform the clinical trial experience for study participants. (more…)
I recently attended the PhUSE Computational Science Symposium (CSS) in Silver Spring, Maryland with a few of my Medidata colleagues, including Tony Hewer, Greg Simpson, Dave Gemzik and Valerio Aimale. The CSS is an annual event co-organized by PhUSE (Pharmaceutical Users Software Exchange) and the FDA that serves as a collaborative environment for all parties to work together on a set of fundamental challenges affecting the wider industry, including diverse topics such as development of standard scripts, making effective use of emerging technologies and defining core concepts (like the cloud), among others. (more…)
Far too often, clinical operation teams battle with lengthy clinical trial management system (CTMS) implementation projects. Can a cloud-based CTMS really change that? Cheryl Larson of Allergan sits down with Medidata expert Les Taylor to delve into some common queries around this shift in our industry. How much effort is required to switch from a legacy CTMS to a cloud-based system? Does it depend on how the legacy system is set up or on the size of the organization? Watch the video to find out answers to these questions and more. (more…)
At a recent risk-based monitoring (RBM) conference in Cambridge, Medidata’s RBM expert Steve Young caught up with Andy Lawton, global head of clinical data management at Boehringer Ingelheim and a member of TransCelerate’s RBM workstream. Andy, along with Sanofi’s RBM lead Lori Convy, led a panel discussion providing an industry update on TransCelerate BioPharma and their RBM plans for 2014. (more…)
Medidata president Glen de Vries was the keynote speaker at last week’s MCT-Congress conference in Edinburgh, presenting a speech entitled, “Measuring Engagement: The Future of Clinical Development.” You can watch Glen’s entire keynote here. (more…)
I must admit that I feel a degree of chagrin when I stop to think that we in the pharmaceutical industry took over 20 years (yes, over two decades) to fully embrace electronic data capture (EDC). To me, it seems to be at odds to work in an industry that is focused on scientific advances in medicine, yet to be so conservative when it comes to adopting new technologies designed to help the clinical trial process. Yes, there has been significant progress in developing a wide array of solutions addressing specific elements of the trial process, from data collection through to submission. (more…)
This year’s ClinTech 2014 Clinical Business and Technology Congress focused on optimizing business systems to accelerate clinical R&D, and Medidata experts Marcus Thornton and Les Taylor presented on implementation and adoption of cloud CTMS. In this event recap, Marcus and Les discuss their talk and share highlights from the lively discussion at ClinTech’s CTMS session. Check out their video!
To excel in a scientific career with an advanced degree, a rigorous and arduous training regimen is required. During the graduate and post-doctoral training phases of this career path, one spends much of their time focused on advancing projects, analyzing data, writing manuscripts and preparing seminars. Most trainees spend their time thinking, What does the data I collected mean?, How does the new information I have discovered fit in to the large amount of information already published in the literature? or Will the final functional assay of the study support, or disapprove, the data I’ve been collecting for the past two years? (more…)
Getting effective treatments to pat ...Medidata Symposium — Thought Lead ...
I recently attended the European Me ...Assessing Opportunities for Risk-B ...
http://youtu.be/jdtjr3qo-qI Many ...Setting the Stage for Real Patient ...
http://youtu.be/U4WUP-BAwf0 A te ...Collaborating at PhUSE CSS: FDA, CD ...
I recently attended the PhUSE Compu ...
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...
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