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…)

13 Aug 2014

Can a Clinical Data Repository Help Drive More Value from All of Your Clinical Data?

by Raj Indupuri

One challenge the life sciences industry currently faces is the lack of infrastructure to manage all the different types of clinical data available. With data in different systems, structures and formats, it makes it very difficult for users to access that data quickly for real-time insights, reporting and analysis. (more…)

11 Aug 2014

Q&A: What Is Triggered Monitoring?

by Geeks Talk Clinical

How is triggered monitoring different from traditional monitoring? Today, clinical research associates (CRAs) travel to clinical sites on fixed visit schedules — visiting each site once per month. But what if CRAs could predict when to visit a site based on how much work needs to get done? (more…)

06 Aug 2014

Taking ePRO to New Places

by David McNierney

Why in this day and age, with people connected 24×7 via smartphones and apps, do clinical trials still use paper to capture patient-reported outcomes (PROs)? ePRO solutions have been around for decades, but up to half of studies still use paper to capture patient assessments. (more…)

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’ ...

Mobile Patient Data Capture — A H ...

http://youtu.be/J1swhCQ6r6A Medi ...

ICON and Medidata Take ePRO to New ...

http://youtu.be/PqQFJ8wMXo8 Toda ...

Ni Hao from Shanghai! 上海的你 ...

A sellout crowd of over 130 people ...

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...