Monthly Features

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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The need for—and barriers to—adopting eSource

Wednesday, February 15, 2017

Electronic data collection responsibility borne by investigative sites to support each clinical trial is onerous, with little to no relief in sight. In many instances, these responsibilities are being managed at the same time that paper data collection processes are prevalent.

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Reassessing site engagement activities

Wednesday, February 1, 2017

Drug development sponsors and CROs increasingly recognize the importance of investigative sites having a stronger, more respected voice in the clinical research community and have begun adopting initiatives designed to incorporate site viewpoints into improving clinical development processes.

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Personalized medicine impacting study conduct

Sunday, January 1, 2017

As the analysis of genetic data is fast becoming a significant part of clinical research programs, both to enroll study participants and understand how drugs work, investigative sites are increasingly asked to collect genetic samples and conduct genetic screenings for clinical trials.

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