22 Oct 2014

TransCelerate and Medidata Explore SDV Effectiveness in Upcoming Webinar

by Geeks Talk Clinical

DataIt’s no secret that clinical trial complexity and drug development costs are at an all-time high. With more than 30 percent of trial budgets allocated to site monitoring costs—and more than half of that being spent on source document verification (SDV) activities¹—the idea of implementing a risk-based monitoring (RBM) program to rid ourselves of the traditional 100-percent-SDV approach has the life sciences industry buzzing.

As long-time proponents of RBM methodologies, we recently teamed up with TransCelerate BioPharma Inc. on a joint initiative to assess the relative effectiveness of SDV on overall clinical data quality, providing TransCelerate with robust data analytics to help determine: (more…)

17 Oct 2014

Investigative Sites Crave Metrics — SCRS Site Solutions Summit Recap

by Stephen Young

The 9th annual Site Solutions Summit on Amelia Island Island brought together clinical research sites and industry leaders to discuss how we can help sites reach optimal performance. Medidata’s Steve Young participated in the “Metrics, Metrics, Metrics: What’s Important” crowdsolving panel discussion, along with peers from INC Research, Quintiles and MedPoint Digital. Check out Steve’s recap for key takeaways from this lively session. (more…)

10 Oct 2014

BYOD @ SCDM

by David McNierney

SCDMWhat happens in Vegas, stays in Vegas, right? Not in this case – too much great info to share!

Last week the Society of Clinical Data Management (SCDM) celebrated the 20th anniversary of their annual meeting where sponsors, clinical research organizations (CROs) and vendors came together to discuss the latest trends. This year’s hot topics included electronic health records (EHR) integration, risk-based monitoring (RBM) techniques and patient bring-your-own-device (BYOD) for outcome reporting.

As a leader in BYOD with our Patient Cloud electronic patient-reported outcomes (ePRO) offering, this topic was of particular interest so we asked visitors to the Medidata booth to take a brief quiz about it. (more…)

30 Sep 2014

The ABC’s of Risk-Based Monitoring

by Geeks Talk Clinical

Medidata’s Richard Young goes over the fundamentals of the new approach to site monitoring that we refer to as risk-based monitoring. (more…)

23 Sep 2014

EDC and ePRO Come Together at SCDM

by Joe Dustin

I’m really excited to head to The Society for Clinical Data Management’s (SCDM) 2014 Annual Conference in Las Vegas. I love coming to this conference every year because it’s a great venue to see customers and colleagues past and present. It’s also a “who’s who” of all those LinkedIN discussion group threads you see in the ever popular “EDC in Clinical Trials Group.” (more…)

16 Sep 2014

Mobile Patient Data Capture — A Huge Step Forward

by David McNierney

Medidata’s Richard Young discusses the evolution from paper, to electronic, to mobile patient data capture. (more…)

10 Sep 2014

ICON and Medidata Take ePRO to New Places

by David McNierney

Today Medidata and ICON announced a joint initiative to deliver ready-to-use, patient-centric solutions to speed trial times and enhance patient engagement. It’s an exciting time to be addressing patient-reported outcomes (PROs) in particular because, while capturing the voice of the patient is important, there is a heightened industry focus on outcomes. (more…)

09 Sep 2014

Ni Hao from Shanghai! 上海的你好

by Ross Rothmeier

ChinaMedidataSYMPOSIUMA sellout crowd of over 130 people attended the largest China Symposium to date, helping make it a phenomenal success from every perspective. With the room filled to capacity, extra seating had to be provided to enable more attendees than expected to join the conversations and talk about how the Medidata Clinical Cloud is indeed transforming clinical development!

Takeru Yamamoto, managing director for Medidata APAC opened the session in Mandarin, setting the tone for a highly collaborative and informative day. (more…)

02 Sep 2014

Patient Engagement: Clinical Trials as a Treatment Option

by Tushar Jain

As we look for ways to engage patients in clinical trials, it’s important to put the needs of patients first. That’s what ePatientFinder aims to do by leveraging the trusted referring physicians relationship. For patients, it means access to life-saving treatments. For physicians, it means increased patient engagement. And for sponsors, it means accelerated recruitment and lower costs and screen fail tests. (more…)

25 Aug 2014

Trends in Clinical Development: Study Start-Up and What Metrics Matter Most

by Todd Tullis

Study start-up in clinical development is an area of intense focus right now. We’re seeing many new trends and industry-wide initiatives, such as TransCelerate who is working on projects focused on facets of study start-up. We’re also seeing cross-collaboration initiatives to help define important metrics, as well as organizational initiatives and ways in which technology can play a big role. (more…)

21 Aug 2014

Rare Disease Patient Advocate Applauds FDA’s Rare Pediatric Disease Voucher Program

by Steve Smith

FDA_RarePediatricDiseaseVoucherAs a rare disease patient advocate—having watched for more than 20 years the struggle for funding of drug development for drugs with small patient populations—I’m glad to see the new FDA Rare Pediatric Disease Voucher Program used for the first time. Three drug developers have completed a transaction between them that utilizes the program in the way it was intended. This shifts money gained from bigger drug revenues into the harder-to-fund rare disease arena.

This new voucher program, another very good part of the new FDA Safety and Innovation Act (FDASIA) passed in 2012, incents companies to develop innovative treatments for rare pediatric diseases. (more…)

19 Aug 2014

Providing Clarity on the Definitions of Source Data Verification (SDV) and Source Data Review (SDR)

by Stephen Young

SDVandSDRIn a risk-based monitoring (RBM) update released in January, TransCelerate defined source data verification (SDV) as “the process by which data within the case report form (CRF) or other data collection systems are compared to the original source of information (and vice versa).” Source data review (SDR) on the other hand, was defined as “a review of source documentation to check quality of source, review protocol compliance, ensure critical processes and source documentation are adequate.” Therefore, according to TransCelerate, “SDR is not a comparison of source data against CRF data.” (more…)

TransCelerate and Medidata Explore ...

It’s no secret that clinical tria ...

Investigative Sites Crave Metrics ...

http://youtu.be/g5jUgcT5N6Q The ...

BYOD @ SCDM

What happens in Vegas, stays in Veg ...

The ABC’s of Risk-Based Monitoring

http://youtu.be/p_8bVA4YwUQ Medi ...

EDC and ePRO Come Together at SCDM

http://youtu.be/nWJybTdHDWU I’ ...

Joe on Mobile Patient Data Capture — A Huge Step Forward
Nailed it.

john anstey on Ni Hao from Shanghai! 上海的你好
Great article. Exciting times ahead. I believe that China will award us the rare opportunity of applying our platform as...

Kajol on Data Management, Safety Systems and How Technology Can Improve Clinical Development Processes
It is a nice blog. It contain good information on clinical data management

Laurie Meehan on Providing Clarity on the Definitions of Source Data Verification (SDV) and Source Data Review (SDR)
Agreed - a new term would have been preferable, but we of course have the benefit of hindsight. We’re...

Steve Young on Providing Clarity on the Definitions of Source Data Verification (SDV) and Source Data Review (SDR)
Thanks Laurie for your thoughts. I agree with your concern regarding the "re-definition" of SDV by TransCelerate - particularly...