Lisa Henderson

But the re-brand of PRA Health Sciences from PRA International strikes a different tone than most.

A well-informed update on how the problems in the Ukraine are impacting clinical trials in the region.

We compiled a list of how sponsors offer access to patient level clinical data requests from researchers.

In back-to-back announcements, Boehringer Ingelheim and Bayer HealthCare announced their pathway to allow access of clinical trial data to qualified researchers.

In early May, Bloomberg news reported the FDA will be conducting studies into generic extended release Toprol XL after almost 3,500 adverse incident reports have amassed since March 2009.

What is quality? For Patricia Leuchten, CEO of The Avoca Group, and the members of its Quality Consortium, quality can be a platform for innovation and change.

DrugDev announced it has acquired TrialNetworks, which offers a unified suite of integrated study management apps and site-facing tools called the Clinical Trial Optimization System. And not unlike its first acquisition of CFS Clinical in October 2013, the acquisition has elements of innovation, scale, and overall industry improvement as its impetus.

With all of the activity in CRO M&As the past three years, it?s slightly amazing that it continues...

Lisa Henderson recaps Roni Zeiger's keynote from the Partnerships in Clinical Trials conference earlier in April.

Kent Thoelke spoke at the Partnerships conference regarding trial conduct differences in China.

In January 2013, FDA told manufacturers to lower the dose of zolpidem for women

Would you delay protocol approval by two months if it meant your enrollment and retention would improve and, in turn, positively affect your data quality?

The first conference I?ll attend this year is in two weeks in Philadelphia, on Data Disclosure and Transparency.

Wingspan Technology will debut its eTMF 2.0 via webcast January 22.

Clinical research professionals who have a current CPI or CCRC designation will be able to use that as evidence that retaking GCP training is not necessary if they are working on a trial for one of the TransCelerate companies.

When serious things go wrong with a trial, such as an adverse event or an incident report is filed, it is easier for project managers to identify a problem that needs to be addressed in a trial.

Applied Clinical Trials is pleased to announce exciting changes to the way we offer content to our readers.

Transparency Life Sciences, LLC, and Dr. Matthew Galsky, Associate Professor of Medicine, Division of Hematology/Oncology at the Icahn School of Medicine at Mount Sinai, have collaborated to design and conduct a pilot trial assessing metformin as a potential treatment for prostate cancer.

BBK Worldwide announced the latest version its Study eBinder

This webcast is free and the expert speakers from Price Waterhouse Coopers, Industry Standard Research and SAS will be discussing their own research and experiences on this topic.

If you are in clinical research, you may read a headline such as "Thomson Reuters Previews Game-Changing New Solutions for Insights into Clinical Trials" with passing curiosity... along the lines of "what do they have to do with clinical trials?"

Last year, I attended the Sponsor/CRO Business Process Integration conference at this same time in New Brunswick, and it was one of my favorites. This year, it's in Raleigh NC.

Companies trusting each other and looking out for each other's interests is the hallmark of outsourcing.

I was lucky to be privy to early results from research being conducted on Risk-Based Monitoring.

JAMA recently announced a change in editorial policy whereby it will no longer have independent academic statisticians review industry-sponsored clinical trial data.

I'm spending some time going through the Draft Guidance for Industry Oversight--A Risk-Based Approach to Monitoring, August 2011 vs. the Guidance for Industry--Oversight of Clinical Investigations--A Risk-Based Approach to Monitoring, August 2013,

A recent Twitter follower asked in regard to RBM technology, "Is there any experience w/regulators utilizing tool data as a roadmap to ID trouble sites during inspections?"

In the past week, I?ve had two interviews and one webinar all related to some form of safety measuring and diagnosis definition primarily in the CNS area.

Recently, the National Health Service (NHS) in the UK announced that there was an increase of NHS patients participating in clinical research.

Next week at DIA, two of TransCelerate?s Risk Based Monitoring workstream members will take their newly released methodology to the people.