FDA Finalizes Historic Rule Providing Access to Over-the-Counter Hearing Aids

Posted by Chad Birt on Sep 6, 2022 7:00:00 AM

In 2017, Congress passed bipartisan legislation requiring the Food and Drug Administration (FDA) to develop a grouping of over-the-counter hearing aids. Though passed more than five years ago, the law is only being implemented now. 

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Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, fda, Clinical Research, Biotech, Pharmaceuticals, biotechnology, pharma, biostatistics, biometrics, FSP, clinical trials, online meetings, project management, Good Clinical Practice, healthy living, patient enrollment, FDA inspections, medical research, food and drug administration, medical patients

Tips for Maintaining Quality Research Amidst the “Great Resignation”

Posted by Chad Birt on Aug 9, 2022 9:26:00 AM

Up to 5 million Americans have left their jobs during the ‘Great Resignation’ and that number’s still growing. While numerous industries are experiencing record turnover, it’s especially acute in healthcare. According to one report, 20% of medical professionals have left the field, including clinical trial assistants, clinical research associates, and study monitors.

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Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, fda, inspection readiness, Data Management, Clinical Research, Biotech, Pharmaceuticals, biotechnology, pharma, qualityassurance, Quality Assurance, biostatistics, biometrics, FSP, Functional Service Provider, clinical trials, project management, data operations, Good Clinical Practice, patient enrollment, patient recruitment, clinical research jobs, clinical outsourcing, FDA inspections, biopharma, biomedical research, medical research, medical device manufacturer, food and drug administration, patients, medical patients, budget, clinical research data management, great resignation, staff shortage, quality data

5 Best Practices for Maintaining a Trial Master File (TMF)

Posted by Chad Birt on Jul 12, 2022 7:45:00 AM

The Trial Master File (TMF) is one of the most important systems in clinical research. It plays a pivotal role in demonstrating your assertion that your clinical study was conducted in adherence to the protocol using the principles of Good Clinical Practice (GCP).

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Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, fda, inspection readiness, Data Management, Clinical Research, Biotech, Pharmaceuticals, biotechnology, pharma, qualityassurance, Quality Assurance, biostatistics, biometrics, FSP, Functional Service Provider, clinical trials, project management, Good Clinical Practice, patient enrollment, patient recruitment, clinical research jobs, clinical outsourcing, FDA inspections, biopharma, biomedical research, medical research, medical device manufacturer, food and drug administration, patients, medical patients, budget, TMF, trial master file

How to Keep Your Clinical Trial On (Or Under) Budget

Posted by Chad Birt on Jun 7, 2022 7:30:00 AM

Designing and implementing clinical trials isn’t cheap. One report submitted to the U.S. Department of Health and Human Services (HHS) found that the average cost of a Phase 1 trial was $4 million, while the average cost of a Phase 3 trial was $20 million. Considering that up to 85% of all trials experience delays, your budget can quickly balloon out of control.

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Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, fda, inspection readiness, Data Management, Clinical Research, Biotech, Pharmaceuticals, biotechnology, pharma, qualityassurance, Quality Assurance, biostatistics, biometrics, FSP, Functional Service Provider, clinical trials, project management, Good Clinical Practice, patient enrollment, patient recruitment, clinical research jobs, clinical outsourcing, FDA inspections, biopharma, biomedical research, medical research, medical device manufacturer, food and drug administration, patients, medical patients, budget

Tips for Improving the Patient Experience in Clinical Trials

Posted by Chad Birt on May 3, 2022 7:36:00 AM

Low patient retention is one of the greatest challenges that clinical researchers face. One study, conducted by the Tufts Center for the Study of Drug Development, found that between 2012 and 2019, patient dropout rates increased from 15.3% to 19.1%. 

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Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, fda, inspection readiness, Data Management, Clinical Research, Biotech, Pharmaceuticals, biotechnology, pharma, qualityassurance, Quality Assurance, biostatistics, biometrics, FSP, Functional Service Provider, clinical trials, project management, Good Clinical Practice, patient enrollment, patient recruitment, clinical research jobs, clinical outsourcing, FDA inspections, biopharma, biomedical research, medical research, medical device manufacturer, food and drug administration, patients, medical patients

Introducing Our Functionally Aligned Strategic Team (FAST™)

Posted by Chad Birt on Mar 28, 2022 7:59:00 AM

If your company is preparing to launch a new drug or medical device, it’s important you have a team of experts supporting you every step of the way. Considering the high costs and amount of risk involved, outsourcing key, strategic components of the work to a Functional Service Provider (FSP) can free up time and help you better allocate resources.

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Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, fda, inspection readiness, Data Management, Clinical Research, Biotech, Pharmaceuticals, biotechnology, pharma, qualityassurance, Quality Assurance, biostatistics, biometrics, FSP, Functional Service Provider, clinical trials, project management, Good Clinical Practice, clinical research jobs, clinical outsourcing, FDA inspections, biopharma, biomedical research, medical research, medical device manufacturer, food and drug administration

Everything You Need to Know About the FDA’s Proposed Benefit-Risk Assessment for New Drug and Biological Products

Posted by Chad Birt on Mar 4, 2022 10:00:00 AM

On September 29, 2021, The Food and Drug Administration (FDA), released a proposed benefit-risk assessment for new drug and biological products. The document, published in draft guidance form, shines a spotlight on the FDA’s decision-making processes. 

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Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, fda, Clinical Research, Biotech, Pharmaceuticals, biotechnology, pharma, qualityassurance, biostatistics, biometrics, FSP, Functional Service Provider, clinical trials, project management, Good Clinical Practice, FDA inspections, supply chain, biopharma, biomedical research, medical research, supply chain management, medical device manufacturer, supply chain shortage, food and drug administration

5 Clinical Trial Trends for 2022

Posted by Chad Birt on Nov 23, 2021 8:26:00 AM

It’s hard to believe, but 2021 is coming to a close. After almost two full years of pandemic-related changes, many industries have had to adapt and evolve just to stay afloat. 

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Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, data mangement, Clinical Research, Biotech, Pharmaceuticals, biotechnology, pharma, qualityassurance, biostatistics, biometrics, FSP, Functional Service Provider, clinical trials, project management, Good Clinical Practice, new years, patient enrollment, FDA inspections

Introducing the Reinvented FSP: Functional, Flexible, and Fractional Service Provider

Posted by Chad Birt on Oct 26, 2021 8:15:00 AM

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.

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Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, data mangement, Clinical Research, Biotech, Pharmaceuticals, biotechnology, pharma, qualityassurance, biostatistics, biometrics, FSP, Functional Service Provider, clinical trials, project management, Good Clinical Practice, patient enrollment, FDA inspections

3 Common Clinical Trial Models and Tips for Choosing the Right One

Posted by Chad Birt on Sep 21, 2021 9:00:00 AM

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. 

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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

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