FSP for All

Posted by Ajay Sadhwani on Aug 25, 2020 6:43:05 PM

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.

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Topics: clinical trial, fda, Clinical Research, Biotech, Pharmaceuticals, biotechnology, FSP

7 Tips for Enhancing Medical Writing Quality and Efficiency

Posted by Ann Conner on Jul 28, 2020 2:47:33 PM

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.

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Topics: clinical trial, fda, Clinical Research, Biotech, Pharmaceuticals, biotechnology, medical writing

Vendor Oversight: Not a New Normal, Just an Interim Normal

Posted by Ann Conner on Jun 23, 2020 9:20:16 AM

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.

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Topics: clinical trial strategic planning, clinical trial consulting, fda, inspection readiness, clinical trial inspection

Inspection Readiness - A Critical Success Factor in Clinical Trials.

Posted by Ann Conner on May 14, 2020 6:45:30 PM

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:

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Topics: clinical trial strategic planning, clinical trial consulting, fda, inspection readiness, clinical trial inspection

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We’re committed to quality and committed to meeting or exceeding your expectations.

Established to be your integrated Quality Assurance and Regulatory Compliance partner, with a laser focus on facilitating your clinical trial execution. Developing and supporting your quality initiatives from Day 1, the Harbor team is committed to quality through each functional service we provide.

We provide a hybrid of services which ensure all aspects of clinical trials meet quality assurance and regulatory standards – from study documentation, vendor oversight, and flexible resourcing throughout operations.

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