Recruitment and retention plans will always be molded by the specific trial and population involved; putting careful thought into who your trial’s target participant is can help bolster enrollment/retention numbers, an expert advises.
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The clinical research industry faces a number of hurdles right now, including workforce struggles, new technologies, growing protocol complexity and enrollment challenges. But things are also on the upswing for small- and mid-sized CROS, says Cheryle Evans, senior vice president of global clinical and biometric operations for Advanced Clinical, a full-service CRO.
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Acknowledging the ever-evolving technological and clinical research landscape, the FDA has published a new draft question-and-answer guidance on using electronic systems, records and signatures in clinical trials, providing greater direction on validation, digital health technologies (DHT) and the applicability of regulatory requirements.
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The Society for Clinical Research Sites (SCRS) has kicked off the Site Payment Initiative, an endeavor that will bring sites, sponsors and CROs together to tackle financial struggles sites frequently name as pain points.
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The FDA has issued a warning letter to a Houston, Texas-based anesthesiologist for failing to submit an investigational new drug application (IND) and obtain informed consent as required in an anesthesia trial.
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