Synexus

Site impact of new ICH/GCP guidelines

Monday, October 16, 2017

The Pulse on Site Success by Christophe Berthoux

The industry largely accepts ICH/GCP guidelines as the gold standard regarding conduct in clinical research, which was recently updated in response to the increasing use of technology as well as findings from regulatory inspections. In November 2016, the second revision to ICH Good Clinical Practices E6 R2 contained an integration of 26 new additions to serve as guidance for clinical study conduct.

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A critical need for timely site payments

Monday, August 28, 2017

The Pulse on Site Success by Christophe Berthoux

Research sites across the globe likely have felt the effects of delayed payments, inconsistent payment amounts and lack of explanation regarding what the payment was for. In a 2016 survey of Investigators conducted by DrugDev, getting paid “on time” was one of the top two burdens reported by sites. Receiving untimely payments not only produces financial stress to the site, it often leads to additional administrative load placed on staff members who must allocate resources to track down payments and deal with discrepancies.

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Opportunities to create a collaborative patient/professional relationship

Monday, July 17, 2017

The Pulse on Site Success by Christophe Berthoux

Increasing participation in clinical trials has long been a topic of discussion in the industry, and obstacles related to regulatory concerns, culture and communication are known to hinder outreach to the patient community. Fortunately, the focus on meaningful engagement has led to new ideas and opportunities to create dialogue between patients and professionals.

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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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Alternative solutions to complement monitoring strategies

Monday, June 5, 2017

The Pulse on Site Success by Christophe Berthoux

Research sites are likely most familiar with traditional on-site monitoring, which requires monitors to conduct visits to check a high percentage of data, and ensure that everything is reported correctly. As clinical trials increase in complexity, on-site monitoring can become an inefficient and expensive process. In order to minimize cost and increase efficiency, Sponsors and CROs are considering several alternative solutions to complement monitoring strategies.

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Synexus, Radiant Research to integrate operations

Thursday, April 27, 2017

European-headquartered Synexus and U.S.-based Radiant Research announced a full operational integration to form a single global site network of 185 sites with 1,500 employees. This move will create the world’s largest site network, spanning 11 countries and offering access to more than 100 million patients in key clinical development markets, operating under the Synexus name.

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Social media tips for research sites

Monday, April 24, 2017

The Pulse on Site Success by Christophe Berthoux

When sites are juggling multiple studies, it can be easy to push social media efforts to the backseat. However, this may deter from opportunities to expand clinical trial awareness and potentially bringing new business to sites. Fortunately, a site can implement tools and processes to allow for social media interaction, while maintaining the balance between keeping up with administrative workloads and providing patient care.

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The importance of providing education and awareness surrounding biosimilar products

Monday, March 13, 2017

The Pulse on Site Success by Christophe Berthoux

It has been seven years since the passing of the Biologics Price Competition and Innovation Act, a provision of the Affordable Care Act that created the approval pathway for biosimilars in the U.S. To date, four biosimilar products have been approved by the FDA, compared to 23 products in the European Union where biosimilars have been in play since 2007.

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