News

FDA released four new draft guidances that seek to broaden criteria for identifying and enrolling patients in clinical trials in an effort to reduce time and cost of clinical research for biopharmaceuticals.

A statement from Europe’s drug industry and Europe’s medical societies calls for a “bold vision” to ensure proper funding and coordination for translational research.

CROs should be more mindful of their smaller emerging biopharma clients and pay more attention to handling their needs.

The “citizen data scientist” is the person with no official data scientist training who uses the latest tools and technologies to handle data wrangling duties, analyze data, and create reports and models.

A leading industry executive in the regenerative medicine space discusses recent advances in stem cell therapy development.

Click the title above to open the Applied Clinical Trials April 2019 issue in an interactive PDF format.

Executives from DIA, Ranjini Prithviraj and Sudip Parikh discuss documents the FDA released that further detail the agency’s implementation plan for its Software Precertification Pilot Program.

CEO of Greenphire, Jim Murphy, shares his takeaways from 2019 SCRS European Site Solutions Summit and illustrates how to further position clinical research stakeholders for success.

Forte announced at their 27th Onsemble Customer Conference that they are forging a modern, technology-led approach towards organizing and analyzing research.

The history of gene medicine is filled with hope, tragedy, and successes. VP of Rare Diseases & Pediatrics for Premier Research, Angi Robinson, writes how patient well-being must always prevail, and challenges mustn’t stop us from helping solve unmet medical needs.

FDA commissioner Scott Gottlieb criticized pharmaceutical companies and clinical research organizations for being slow to adapt innovations in clinical research, claiming that the business model adopted just isn’t compatible with the kind of changes that certain innovations can enable.

A statement from Europe's drug industry and medical societies calls for adequate funding for translational research, explaining the importance, and highlighting the challenges it faces.

A look at what patient centricity in clinical research means and how it has evolved.

Insights from ExL’s 5th Clinical Trials Phase I & Phase IIA Summit on early phase trials.

Norman (Ned) Sharpless, director of the National Cancer Institute at the National Institutes of Health, will become FDA acting commissioner.