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…)

04 Aug 2014

Randomization and Trial Supply Management (RTSM) — What’s In a Name?

by Ehsan Ramezani

RTSMI have a keen interest in a particular area of clinical technology that has been called different things over the last 25 years or so that it’s been in existence. Whether it is referred to as Interactive Voice Response (IVR), Interactive Web Response (IWR), Interactive Mobile Response (IMR), Interactive x Response (IxR) or even Interactive Response Technology (IRT), the fact remains that the technology serves a particular purpose — namely to support the act of clinical trial randomization and associated drug supply management. What’s interesting is that this clinical technology has become a virtually indispensable standard part of the eClinical toolkit yet, in online forums (like this IVR/IWR LinkedIn forum) and industry conferences, a continuing trend is reflected by suppliers, key opinion leaders and sponsors. (more…)

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…)

Rare Disease Patient Advocate Appla ...

As a rare disease patient advocate ...

Providing Clarity on the Definition ...

In a risk-based monitoring (RBM) up ...

Can a Clinical Data Repository Help ...

http://youtu.be/Kjn7Yo4joFM One ...

Q&A: What Is Triggered Monitoring?

http://youtu.be/JojyZqyKFDQ How ...

Taking ePRO to New Places

Why in this day and age, with p ...

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...