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.

Read More

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).

Read More

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.

Read More

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%. 

Read More

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

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. 

Read More

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.

Read More

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. 

Read More

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:

Read More

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

5 Tips For Recruiting (And Retaining) Clinical Trial Participants

Posted by Chad Birt on Feb 3, 2021 9:30:00 AM

Clinical trials play a critical role in identifying and developing new treatments. They advance medical research, allow for improved patient outcomes, and enhance our knowledge of human biology. Unfortunately, they aren’t always easy to recruit for. In fact, approximately 85% of clinical trials fail to enlist enough participants to move forward.

Read More

Topics: clinical trials, patient enrollment, patient recruitment, study start up

Learn More From Us

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.

Watch our blog for articles that help you get the most from your clinical trials.

Subscribe Here!

Recent Posts

Posts by Tag

See all