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 The document, published in draft guidance form, shines a spotlight on the FDA’s decision-making processes.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

Rare Disease Day 2022: How The Pharmaceutical Industry Has Stepped Up and Tips for Bringing Treatments to Market

Posted by Chad Birt on Jan 25, 2022 8:00:00 AM

Imagine being diagnosed with an incurable disease. Now, imagine being diagnosed with an incurable disease that affects less than 2,000 people globally. That’s the reality more than 300 million people are living worldwide. The reality of life with a rare disease.

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Topics: clinical trial, clinical trial strategic planning, clinical trial consulting, clinical trial remote services, Clinical Research, Biotech, Pharmaceuticals, biotechnology, pharma, qualityassurance, biostatistics, biometrics, FSP, Functional Service Provider, clinical trials, project management, Good Clinical Practice, supply chain, biopharma, biomedical research, medical research, supply chain management, medical device manufacturer, supply chain shortage, rare disease awareness, rare diseases, genetic diseases

What Medical Device Manufacturers and Biopharmas Can Do to Reduce Supply Chain Headaches

Posted by Chad Birt on Dec 14, 2021 9:00:00 AM

For more than a year now, the global supply chain has experienced significant disruptions. At the beginning of the COVID-19 pandemic, factories manufacturing everyday objects like semiconductors, personal protective equipment, and bicycles, shut down resulting in global product shortages and long-lasting headaches for many business owners. 

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

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

4 cost-effective strategies for recruiting clinical trial participants

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

Designing and implementing a clinical trial is a time-consuming and costly process. In fact, a 2014 report by Aylin Sertkaya et al. submitted to the U.S. The Department of Health and Human Services found that on average:

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Topics: clinical trial strategic planning, clinical trial consulting, clinical trial remote services, Clinical Research, Pharmaceuticals, clinical trials, patient enrollment, patient recruitment

FDA Inspections - What They Are and How to Prepare

Posted by Chad Birt on Jul 20, 2021 8:45:00 AM

Food and Drug Administration (FDA) inspections are a routine aspect of operating an investigational site. Even so, the thought of an FDA auditor visiting your facility can be incredibly nerve-wracking, especially if you haven’t taken the necessary steps to prepare.

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Topics: Clinical Research, Pharmaceuticals, FDA inspections

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