Monthly Features

Preparing sites for acquisition

Saturday, July 1, 2017

The unprecedented level of M&A activity in the clinical research site sector during the past 24 months has spurred many investigative site owners to consider selling their businesses.

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Revisiting patient diversity in clinical trials… again

Saturday, July 1, 2017

Minority groups have historically been excluded from clinical research, an inequity that has led to well-documented public health problems in which therapies tested primarily in Caucasian patients do not work as well in other ethnic and racial groups. This problem is famously exemplified by Sanofi’s blood thinner Plavix, which was approved in 1997 but slapped with a boxed warning in 2010 after researchers realized up to half of Asian and Pacific Islander populations cannot process the drug.

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Assessing the strategic impact of supply chain management

Thursday, June 15, 2017

The globalization of clinical trials and more complex protocols, which include adaptive designs and those for targeted therapies, have driven the need for new practices and strategies to reduce waste and inefficiencies in the clinical supply logistics area.

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Preparing for the ICH E6 Revisions

Monday, May 1, 2017

In November 2016, the International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) issued Step 4 of the new Good Clinical Practice (GCP) E6 (R2) guideline. A core principle of E6 (R2) is the integration of quality management (QM) and risk-based approaches to span the entire clinical trial process. The addendum embodies the concept of proactive planning for quality, oversight, preventive action and documentation.

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Envisioning the site of the future

Monday, May 1, 2017

The drug development world has been notoriously slow to adopt change, but industry leaders and visionaries expect the clinical research enterprise to change dramatically.
Integration of healthcare data, the power of data and analytics, a rapid move toward more targeted therapies and customized treatments, along with the desire for a lower cost R&D model are among the forces driving transformation in the way the research environment will function in the future.

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Millennials accelerate seismic shift in clinical operations

Saturday, April 1, 2017

As the largest age demographic in the U.S., Millennials are dramatically reshaping the clinical research industry. Millennials have high expectations about technology, convenience and data transparency—traits that are catalyzing a trend toward decentralization and prompting industry leaders to carve out new roles in clinical trial management.

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PSI, INC, Chiltern take top site ratings

Saturday, April 1, 2017

Investigators report their working relationships with CROs have become more effective during the past two years, according to a new CenterWatch survey, and nearly half said overall CRO performance, for the first time, matches that of sponsor companies.

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Sites wrestle with protocol design complexity

Wednesday, March 1, 2017

The growing complexity of protocols is resulting in longer cycle times, rising costs and increased pressures on staff and patients throughout the clinical trial process. Tufts Center for the Study of Drug Development (CSDD) studies have found that the number of endpoints, procedures and eligibility criteria of typical phase III protocols increased significantly during 2002-2012, and have continued to grow. These factors combine to increase costs and burdens on research teams.

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Novo Nordisk, Servier, Otsuka, Teva among top sponsors

Wednesday, March 1, 2017

Sponsors have done a good job of maintaining, but not improving, the overall quality of their relationships with investigative sites during the past two years, according to a new CenterWatch survey, but performance gaps have widened across several of the attributes sites identify as the most important for conducting a successful study.

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