Drugs

Develop Clinical Trial Data Strategy: Consultants

A YourEncore white paper says that although a data strategy is critical to the successful completion of clinical trials, only one-third of companies responding to a survey said they had such a strategy. “Each company should invest the time and resources to develop a comprehensive strategy,” the paper says.

The firm says it is critical to have a data strategy that:

facilitates data standardization, leading to increased efficiency throughout clinical trial execution, from setup to reporting;
documents policies in a central location to ensure consistent and rapid decision-making;
documents how regulations are interpreted to ensure a consistent approach to compliance;
identifies approved vendors and the process for approving new vendors to facilitate data integration;
establishes a mechanism for evaluating and implementing new processes and technologies, ensuring a standard and cost-effective approach with appropriate oversight and cross-functional input; and
measures the effectiveness of the data management processes and systems through key performance indicators and establishes productivity and quality targets.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome