Experts Advocate ‘High-Touch, High-Tech’ Clinical Trial Approach

The oncology clinical trial patient spoke positively of her long, arduous experience. Did she praise the wearables and other innovative technologies that made the trial more convenient? Did she go on and on about the high-quality contract research organization facility? Nope. “She focused on how the nurse called her every night during the trial to […]

Innovative Heart Study Could Advance Clinical Trial Design

An innovative study of patients with heart failure that will monitor functional capacity and quality of life to see if greater emphasis should be placed on these measures in the drug approval process could “advance the science of clinical trial design,” says Kuldeep Singh Rajput, CEO of Biofourmis. His organization has entered a research partnership […]

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Regulators, Industry Debate Meaning of Real-World Evidence in Trials

There’s no shortage of buzzwords in the clinical trial industry. Patient centricity and virtual trials have been flavors of the month for some time now, for example. But for pure staying power, real-world evidence (RWE) has a pretty impressive track record, too. Unfortunately, as evidenced by a slew of recent comment letters, regulators and industry […]

Clinical Trial Practitioners Extol Virtues of Training, Certification

Adequately trained monitors/clinical research associates (CRAs) “will be prepared for just about anything” an increasingly complex clinical trial landscape is liable to throw at them, says Maggie Potrikus, BSN, CCRC, MBA, a quality assurance and compliance manager with Concentrics Research, a contract research organization (CRO), and former contracted CRA to Roche Diagnostics. On the other […]