The FDA’s Dr. John Whyte recently shared his perspectives on patient centricity at eyeforpharma’s Patient Centered Clinical Trials conference. He continues the discussion by exploring the definition of patient centricity and issues that not only the FDA, but also the industry is facing.
Data sharing in biomedical research has recently attracted widespread attention from physicians, scientists and stakeholders alike. DCRIs Dr. Eric Peterson discusses the context, flaws and positives of how this initiative could be implemented and the effects it can have on the industry.
LabConnect has announced the launch of its data integration services which aims to assist sponsors in coordinating high-volume data collection and management from multiple laboratory data sources.
Finding and implementing an appropriate design for early-stage clinical trials is critical to the future success of medicines for central nervous system (CNS) disorders, according to new analysis from the European Medicines Agency (EMA)
The Clinical Data Interchange Standards Consortium (CDISC) is reminding the clinical research community that the FDA Binding Guidance goes into effect in December.
The latest official review of European health strategy has been released at the request of the European Commission in an attempt to address Europe’s healthcare challenges. Peter O’Donnell reports that the clinical trials community is likely to be disappointed at the report’s findings.
The Society for Clinical Research Sites (SCRS) announces that Roche has become a Global Impact Partner (GIP).
Updated employee announcements, business news and recognition in the industry today.
Medidata has launched its new eConnect Partner Program.
TKL Research, a dermatology specialty clinical research organization, has agreed to sell its Clinical Trials Division to QuintilesIMS.
Vendor oversight in clinical trials is a subject not often discussed despite a disconnect in how it is carried out between multiple departments. Celeste Gonzalez of Boston Scientific shares her perspectives on the subject.
Clinerion announces a new service for use with its Patient Recruitment System (PRS).
Gamification is the application of game design principles and techniques to non-game contexts intending to create value for players and stakeholders alike. If applied, this principle can potentially drive greater innovation and efficiencies in clinical research.
Bracket announced the acquisition of international software development and consulting firm CLINapps Inc.
Comprehend recently released a survey of over 100 Clinical Operations leaders providing consensus on their goals, challenges and best practices for CRO Oversight.
DrugDev has announced the acquisition of SecureConsent, a provider of electronic informed consent solutions.
TransCelerate’s recently published article in a DIA publication covered issues management in clinical trial Quality Management Systems (QMS). Abbvie’s Susan Callery-D’Amico speaks to us about TransCelerate’s QMS Initiative and Issue Management.
Have the roles of the monitor advanced? How are CRAs accepting the change? How is pharma implementing RBM-is it more remote, centralized or a combination? How important is eSource to RBM? This eBook will highlight articles that answer these question.
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