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. 

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.

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.

At Harbor Clinical, we provide expertise to small/mid-sized biotech/pharma companies   to ensure the best possible outcomes of the clinical trials that are  crucial to their company’s success.  We provide subject matter experts across functional areas including quality assurance, vendor oversight, clinical operations, medical writing, regulatory, biometrics and strategic development.