The last year and a half have been a whirlwind, particularly for clinical researchers. While the trial landscape is ever-evolving, efforts to “slow the spread” of COVID-19 have accelerated the process.
Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, Clinical Research, Biotech, Pharmaceuticals, biotechnology, biostatistics, biometrics, FSP, clinical trials, online meetings, project management, Good Clinical Practice, patient enrollment, FDA inspections
Designing and implementing a clinical trial is a time-consuming and costly process. In fact, a 2014 report by Aylin Sertkaya et al. submitted to the U.S. The Department of Health and Human Services found that on average:
Food and Drug Administration (FDA) inspections are a routine aspect of operating an investigational site. Even so, the thought of an FDA auditor visiting your facility can be incredibly nerve-wracking, especially if you haven’t taken the necessary steps to prepare.
Are you a clinical research assistant who dreams of becoming a clinical research manager or clinical operations director? When you’re just starting out, achieving a leadership position might seem like an impossible task, but if you plan ahead and map out a route, it’s absolutely possible.
A recent investigation published by JAMA found that the average cost of bringing a new drug to market is $1.3 billion. Considering only 12% of new pharmaceuticals receive FDA approval, developing these products requires large amounts of money and even more risk.
Are you a professional in the health care or life sciences industry who wants to try something new? Does the thought of contributing to the discovery of new drugs or medical devices inspire you? If you answered yes to either of these questions, consider pursuing a career in clinical research.
Podcasts have exploded in popularity over the course of the last decade. What was once a niche entertainment option is now mainstream, providing enjoyment to millions of Americans each month.
Clinical trials play a critical role in evaluating the effectiveness of medical, surgical, or behavioral interventions. They’re the go-to method when determining if a new vaccine, prescription medication, or medical device is safe and successful in its goals.
Each organization has its processes and methodologies on how to vet critical decisions among its stakeholders. The criteria used for decision making are typically well defined and understood. Crisply allowing a good comparison of the options or trade space to have the decision be more apparent to the stakeholders requires some planning and creativity. This blog focuses on such techniques that may be useful to apply in Clinical Studies to make for a more engaging and efficient decision-making process. A brief introduction on the techniques is discussed and a relevant example on application of these techniques follows.
In every organization regardless of industry, team meetings are a big part of a normal work day/week. Meetings are critical to ensure adequate communication across team members, especially in today’s environment with a highly diversified workforce that operate in multiple locations. It is certainly a common experience that some meetings are not as efficient as others and some are downright not worth the time spent at them! This blog focuses on some useful approaches for conducting effective meetings, specifically in a clinical study.