Featured Editorial
One Person Closer Attempts To Inspire Doctors And Patients
By Ed Miseta, Chief Editor, Clinical Leader

Patient recruitment remains a challenge for most companies performing clinical research. One of the factors that will lead to many individuals being completely unaware of trials is the limited communication between doctors and patients about opportunities to participate in clinical studies.

Designing Clinical Studies To Avoid Regulatory Scrutiny
By Jason Mehta and Lee Bentley, Bradley Arant Boult Cummings LLP

Earlier this year, the Department of Justice (DOJ) announced a $3.5 million settlement against Primex Clinical Laboratories, a California laboratory providing clinical diagnostic testing services. As if that multimillion-dollar fine was not ominous enough, the DOJ announced another settlement in the same press release: It had imposed a $270,000 fine against the CEO of a related pharmacogenetics testing facility. The alleged wrongdoing centered on “sham” clinical trials, purportedly designed to mask improper payments to physicians who ordered pharmacogenetics tests.

Industry Insights
Best Practices For User-Acceptance Testing Of Clinical Software
Guest Column | By Kathleen Greenough and Laura Araujo, 4G Clinical
How to get the most out of your user-acceptance testing (UAT) process and focus your efforts where they should be focused.
How To Enhance Efficiencies In Clinical Development And Market Approval
Guest Column | By David Shoemaker, Rho

Once a sponsor has completed research and clinical trials, and believes enough evidence is available on the safety and effectiveness of the new drug, the final step of the development process is to submit an application to regulatory authorities to gain approval for marketing the product. The application must contain data outlining the technical specifications of the product, as well as statistical analyses demonstrating the safety and efficacy of the new molecular entity as evidence of the acceptable benefit:risk profile.

Unlock The Value Of Your Clinical Trial Data With Big Data Discovery
White Paper | Medidata Solutions

From leisure activities, to our own health and wellness, to the industries in which we work — Big Data has transformed our world. Subscription-based content providers, such as Netflix and Amazon Prime, are changing television programming by using detailed customer segmentation and viewing habits to rethink how new programming is funded, produced, and released to the market. Everyday items such as Nest are transforming home heating and cooling by collecting and aggregating sensor data to automate thermostat changes.

Adapting To The Medical Monitor: Driving Tech Adoption In Clinical Analytics
White Paper | PerkinElmer, Inc.

The reasons behind the physician monitors’ reluctance, and what technology needs to offer to convince monitors their work can be more efficient — quickly detecting safety signals and speeding time to submission.

The Full Deal Life Cycle: M&A Network Services
Intralinks, a Synchronoss Business
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