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While most clinical trial sponsors continue to use paper data collection methods, more sponsors are using technology in their studies and recognize the need for electronic standards, according to a recent survey that included drugmakers and investigative sites.
Drug manufacturers undergoing mergers and acquisitions face myriad challenges as they combine and trim staffs, business operations and facilities. During this time of upheaval, organizations should pay special attention to IT integration, a Pfizer executive recently said.
The pharmaceutical industry’s new digital signature standard is eliciting praise from pharmaceutical IT experts and federal regulators, who are touting the standard’s potential for reducing paperwork, cutting costs and fostering interoperability among the drug industry’s many different players.
Jim Rinaldi, the FDA’s chief information officer (CIO), is leaving the agency to take the same position at the Jet Propulsion Laboratory, a federally funded research and development facility managed by the California Institute of Technology for the National Aeronautics and Space Administration in Pasadena, Calif., the FDA announced.
Even as Cyberonics plans the market rollout of its vagus nerve stimulator (VNS) system to treat depression in adults, critics are charging that the FDA rushed to judgment over a product that has not yet been proven to work effectively — or even at all.
The pharmaceutical industry’s new digital signature standard is eliciting praise from pharmaceutical IT experts and federal regulators, who are touting the standard’s potential for reducing paperwork, cutting costs and fostering interoperability among the drug industry’s many different players.
Drugmakers need to take a more active role in developing and promoting federal healthcare IT projects — specifically those related to electronic prescribing systems (“eprescribing”), according to members of a PhRMA committee.
The pharmaceutical industry’s new digital signature standard is eliciting praise from pharmaceutical IT experts and federal regulators, who are touting the standard’s potential for reducing paperwork, cutting costs and fostering interoperability among the drug industry’s many different players.
The FDA’s plan to consolidate its IT organization, processes and infrastructure into an IT shared services organization will speed new technology adoption and lower operating costs, according to the agency’s chief information officer.
Pharmaceutical companies that coordinate the role of their firms’ IT processes with their clinical development and marketing procedures will be better prepared to overcome internal and external challenges that may limit business success, a technology expert recently said.