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.
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.
A new report from the Stanford Institute for Economic Policy Research (SIEPR), found that 42% of Americans are currently working from home full-time.
An earlier blog had identified the benefits of using Earned Value Management (EVM) techniques in Clinical Studies. This synopsis provides a practical example of how to implement those techniques and making useful decisions from the available data. To support this example, a mock study with the following scope of work, budget and timeline requirements has been established:
At the start of the COVID-19 pandemic, many companies asked employees to leave the office and work from home. This helps reduce the viruses’ spread in work environments but also presents unique challenges.
As resource forecasting for 2021 commences, it is a good time to visit existing resourcing models to ensure they can satisfy the demands of your development pipeline. One model worthy of consideration in a variety of areas is the Functional Sourcing Model (FSP). While FSP is traditionally thought of as applicable to companies with large programs and pipelines, it is increasingly being used by smaller companies who want the same benefits afforded by the FSP model which include: risk mitigation via tighter control over operational processes, consistency, scalability and flexibility in resource management, and cost controls on clinical trial conduct.