Harbor Clinical Blog

Bringing a new drug, therapy, or medical device to market is a time-consuming and cost-intensive process. In fact, the average clinical trial takes six or seven years to complete with a typical price tag of $2.6 billion.

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. 

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.

In January 2017, our founder, Ann Conner, established Harbor Clinical as a woman-owned business. Two years later, in January 2019, we were certified by the Women’s Business Enterprise National Council (WBENC). WBENC is America’s largest certifier of women-owned businesses and a leading advocate for women business owners and entrepreneurs.

As sponsors continue to restart paused studies, there will be a flurry of medical writing activities taking place to support IND submissions, investigator brochures, protocols, and other documents. Given that, below are tips to help improve the quality and efficiency in creating these documents.

by Larry Claflin Jr.

Planning a vacation in the middle of a global pandemic with limited travel options?