Saving a Struggling Safety Study

Selecting a contract research organization (CRO) from among the 1,000 or so competitors is a challenging task for any sponsoring pharmaceutical or medical device company. But, it is particularly difficult for an inexperienced team at a startup just entering Phase 1 human trials with their first new product. Such young companies are often working under extreme deadlines imposed by shortsighted venture capitalists clamoring for a press release announcing the start of clinical testing to buoy the stock price.

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Keeping an Arrhythmia Trial in Perfect Rhythm

Monitoring a clinical research study requires more than comparing case report forms against medical records. The fate of an entire clinical trial may rest upon a clinical research associate’s less apparent skills. The diligence, professionalism and exceptional communication skills of an experienced clinical research associate may be needed to salvage a critical situation. This was one such situation where the clinical trial sponsor wisely insisted on an Emissary clinical research associate to monitor an important clinical trial.

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