Lisa Henderson

Approved by the European Parliament in April 2014 is EU Regulation 536/2014, which replaces the decade-old Directive 2001/20/EC – the Clinical Trials Directive. While approved last year, it does not apply earlier than May 28, 2016-leaving interested parties only nine months to prepare for its arrival.

CRO is the first to participate in IACOR’s accreditation pilot.

In light of two recent announcements, and this excellent article from Bloomberg it appears the role of social media in post-market adverse event reporting is being taken seriously by the FDA.

 Last month, Veeva Systems unveiled the results of its 2015 Paperless TMF Survey: Annual Report. The survey is in its second year, and as Jennifer Goldsmith, vice president of Veeva Vault, told Applied Clinical Trials, it was interesting and significant to report on the year-over-year results.

Recently, Applied Clinical Trials formed a Project Manager Committee, whose members will advise us on matters important for them to succeed in their positions

Lexicon early on established an expanded access trial for those who screen-failed that would collect long-term safety data.

In a move designed to both tout the importance of precision and to improve the sponsor experience in conducting cardiac safety assessment, iCardiac Technologies announced a full risk-sharing program for Thorough QT studies.

Organized by country and topic area, the site also allows users to compare the requirements of two countries side-by-side.

eSource is not a new term. But eSource does seem to be getting a lot of attention lately.

 ResearchKit is Apple’s foray into clinical research based on the backbone of its HealthKit, released  in June 2014, which offered the ability for health and fitness apps to communicate with each other. mHealth News reported Apple CEO Tim Cook said, “As we worked on HealthKit, we came across an even broader impact that iPhone could make, and that is on medical research.”

ERT’s announcement of its intention to acquire PHT makes more than sense. And when speaking with the companies’ CEOs, Jim Corrigan and Philip Lee respectively, the potential for success is greater than any challenges the current clinical trials market could throw their way.

In early January, Novartis selected Qualcomm Life as a global digital health collaborator for its Trials of The Future program. That program is designed to leverage healthcare technology to improve the experience of clinical trial participants and patients using Novartis products.

This week, I attended CBI’s Expanded Access Programs conference in Philadelphia.

After a five-year review of clinical trial quality measurement research and practices, we have concluded that clinical trial quality measurement does not meet current scientific standards

Combing for clinical trials patients and the best way to make the match between trial and patient is a multifaceted task.

Over a year ago, Claravant started the research and vetting required to “handicap” the risk of a drug being approved by FDA, and ultimately becoming commercialized in the form of a ratings system.

Clinical trials need to become a part of the treatment continuum, not separated from it as it is now.

Here is a summary of what analysts are saying about LabCorp's purchase of Covance.

This month, the New England Journal of Medicine published the results of data sharing from pharmaceutical companies to researchers.

Issues being discussed with the Ebola vaccine sound like issues discussed with clinical trials in general. What can we learn?

Applied Clinical Trials wanted to know if Tess had any thoughts or recommendations around clinical trials after being a participant.

To date, Quintiles has been the only CRO with representations at events hosted by the House of Representatives Energy & Commerce Subcommittee on Health's 21st Century Cures initiative.

President and Co-founder of Canadian CRO Scimega Research, Denise Deakin, addresses last week's article published in the Toronto Star

Last August, Quintiles announced its intention to purchase Novella Clinical, specifically for its focus on small and mid-sized oncology biopharma clients, as well as medical device and diagnostics companies.

Rare disease research offers a lot for people in the world of clinical trials and drug development to think about.

There are 7,000 rare diseases affecting approximately 350 million people around the world.

In mid-July, the SAS Press Program released a new book titled Risk-Based Monitoring and Fraud Detection in Clinical Trials Using JMP and SAS.

Dr. Paul Wicks, head of innovation at PatientsLikeMe, detailed for Applied Clinical Trials, the three services the company announced at DIA.