News

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.

Designed to ensure patients and patients in clinical trials safely receive their proper medications, the regulation serves as a verification measure to enforce the European Union’s Falsified Medicine Directive.

The new Clinical Conductor contains a myriad of enhancements that foster more precise reporting and analysis.

July 14, 2015 – ROCHESTER, NY – The latest iteration of Clinical Conductor CTMS continues the proven strategy of providing research organizations with the most in-depth features and functionality available, further distancing the application from others in the industry, which fail to provide the tools necessary for truly complete clinical research management.

Considerable quality investments over the past decade have had little demonstrable impact on clinical trial performance and quality.

The use of small animal models in basic and preclinical research is now an integral part of developing and testing new drugs.

 It is well known within the industry that being on a sponsor’s preferred provider list affords a critical leg up to providers hoping to win business. Phase II/III work is no exception. In the 7th edition of Industry Standard Research’s CRO Quality Benchmarking - Phase II/III Service Providers report, ISR digs a bit deeper into the dynamics of preferred provider lists and how these lists affect CRO selection for Phase II/III studies.

An independent judging panel will select three finalists from the submissions.

OmniComm Systems, a global provider of clinical data management technology and services, announced that it has signed a reselling partnership agreement with Tri-I Biotech Shanghai Inc.

Synexus has announced plans to open three new research centers in Bulgaria, Poland and Romania.

Almac Group announced the successful completion of the Health Sciences Authority (HSA) inspection of its new Asia Pacific headquarters in Singapore.

Parexel announced expanded services and capabilities in model-based drug development (MBDD) through its Quantitative Clinical Development (QCD) group.

Certara®, a global biosimulation technology-enabled drug development company, announced the merger of its consulting group, Pharsight Consulting Services.

In response to increasing demand of Sharp Clinical Services.

goBalto, Inc., a provider of cloud-based clinical study startup solutions, announced its latest version of goBalto Activate.

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Navitas, a regulatory service provider, announced that it has opened a new Latin America hub in Bogota, Colombia. Navitas' expansion into Latin America offers bilingual resources (Spanish and English) and provides document, report and submission level publishing for simple and complex submission applicatioms.