Given our recently-modified approach to executing clinical trials due to the COVID-19 pandemic, it is critical that we update our vendor oversight approach, ask key questions of our vendors, and modify our strategy based on the answers to these questions. Harbor Clinical has the experience, expertise, and plan to assist you in adapting your vendor oversight quickly and effectively.
A consistent challenge in conducting clinical trials of new pharmaceutical products is staying in compliance with governmental requirements. Governmental organizations such as the FDA in the United States conduct inspections with the purpose of verifying that the clinical trial is adhering to the requirements and standards in force. The FDA, for example, will conduct inspections for the one or more of the following reasons:
The expanding Coronavirus (COVID-19) global crisis has governments, companies and people implementing plans to respond, meanwhile, governments and businesses still must run, and people still need to lead their lives. At Harbor Clinical, we’re prepared for events like this by having effective plans to work remotely in place.
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.