Sponsors take action to reduce protocol amendments

Protocol amendments commonly have been considered an inconvenient—but inevitable—part of drug development. A recent Tufts CSDD study found each amended protocol has an average of 2.3 amendments, resulting in four months of additional time to implement. On average, the study found it cost nearly a half-million dollars to implement a single protocol amendment. It indicated a large proportion of them could be prevented. Now, a few leading biopharmaceutical companies have launched efforts to reduce and prevent certain amendments through better protocol designs and...

EHR integration could change the game for clinical research

A few short years ago clinical research sites struggled with moving their paper systems to electronic form. The automation added efficiencies, but information often had to be re-entered into different systems, adding errors and taking time from patient care. Now, a different kind of electronic integration is poised to redefine how sites conduct research studies and gather data. Proponents say the electronic health record can eliminate duplication of data, reduce the overwhelming administrative costs and create...

Eye On Isis Pharmaceuticals

Isis Pharmaceuticals focuses on antisense drug development, applicable to many different disease targets. Its strategy includes licensing its drugs to partners before late-phase development and marketing. This allows Isis to direct its capital to discovery and early development rather than commercialization and sales, while still benefiting from licensing fees, equity purchase payments, milestone payments and R&D funding. To protect its status as an innovator in RNA-based drug discovery and development, Isis has implemented a patent strategy...

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