EMA Marks 20th Anniversary with Congress & Book
March 19th 2015To celebrate 20 years since its opening, the European Medicines Agency (EMA) organized a one-day meeting this week. Called “Science, Medicines, Health: Patients at the heart of future innovation”, the invitation-only event in London focused on the EMA’s future role
Western Institutional Review Board Receives ISO Certification
March 16th 2015WIRB-Copernicus Group (WCG), the world’s largest provider of regulatory and ethical review services and software to support clinical research, announced today that its Western Institutional Review Board® company has been certified to ISO 9001:2008 by BSI.
Where is the “Quality” in GCP?
March 16th 2015Over the years, clinical study management has become more fragmented. There are more organizations participating in a study, each bringing their own experiences, interpretations of requirements including how quality is defined. How is it possible that requirements and quality be interpreted so differently?
Medical Device Sponsor Receives FDA Approval Using Target Health's Services
March 12th 2015?Lund, Sweden-based Dignitana, a manufacturer of medical cooling devices, engaged CRO Target Health in 2011 toward its approval of DigniCap® System, its product to protect cells and hair for patients in chemotherapy treatment.
SCRS Expands Relationship with Acurian
March 12th 2015The Society for Clinical Research Sites (SCRS), a global trade organization dedicated to representing the interests of clinical research sites, announced an expanded relationship with Acurian Inc., a full-service provider of global patient enrollment and retention solutions and a subsidiary of PPD.
Pfizer Deploys Pharmacovigilance Solution to US Market
March 11th 2015MyMeds&Me, a SaaS provider of web-based adverse event and product quality complaint capture solutions for life sciences, announced the deployment of its Reportum® solution across all Pfizer safety call center sites in the United States.