--- title: Harbor Clinical Blog | clinical outsourcing description: clinical outsourcing | Harbor Clinical Blog - Clinical Trial planning, quality control and execution for biopharma companies --- [![Harbor Clinical](https://blog.harborclinical.com/hs-fs/hubfs/HC.jpg?width=167&name=HC.jpg) ![Harbor Clinical](https://blog.harborclinical.com/hs-fs/hubfs/HC.jpg?width=237&name=HC.jpg)](https://www.harborclinical.com/) - [ABOUT](https://www.harborclinical.com/about-us/) - SERVICES - [Quality Assurance](https://www.harborclinical.com/quality-assurance/) - [Vendor Oversight](https://www.harborclinical.com/vendor-oversight/) - [Clinical Operations](https://www.harborclinical.com/clinical-operations/) - [Medical Writing](https://www.harborclinical.com/medical-writing/) - [Regulatory](https://www.harborclinical.com/regulatory/) - [Strategic Development](https://www.harborclinical.com/strategic-development/) - [Biometrics](https://www.harborclinical.com/biometrics/) - RESOURCES - [Business Cases](https://www.harborclinical.com/business-cases/) - [Events](https://www.harborclinical.com/events/) - [JOIN OUR TEAM](https://www.harborclinical.com/careers/) - [CONTACT](https://www.harborclinical.com/contact/) # Harbor Clinical Blog ## [Tips for Maintaining Quality Research Amidst the “Great Resignation”](https://blog.harborclinical.com/blog/greatresignation) Posted by [Chad Birt](https://blog.harborclinical.com/blog/author/chad-birt) on Aug 9, 2022 9:26:00 AM - [Tweet](https://twitter.com/share) [![quality data in clinical research ](https://blog.harborclinical.com/hubfs/datablog.jpeg)](https://blog.harborclinical.com/blog/greatresignation) Up to 5 million Americans have left their jobs during the ‘[Great Resignation](https://www.weforum.org/agenda/2021/11/what-is-the-great-resignation-and-what-can-we-learn-from-it/)’ and that number’s still growing. While numerous industries are experiencing record turnover, it’s especially acute in healthcare. According to one report, [20%](https://www.healthleadersmedia.com/human-resources/great-resignations-toll-healthcare) of medical professionals have left the field, including clinical trial assistants, clinical research associates, and study monitors. [Read More](https://blog.harborclinical.com/blog/greatresignation) 1 Comment [Click here to read/write comments](https://blog.harborclinical.com/blog/greatresignation#comments-listing) Topics: [clinical trial](https://blog.harborclinical.com/blog/tag/clinical-trial), [clinical trial strategic planning](https://blog.harborclinical.com/blog/tag/clinical-trial-strategic-planning), [clinical trial consulting](https://blog.harborclinical.com/blog/tag/clinical-trial-consulting), [clinical trial remote services](https://blog.harborclinical.com/blog/tag/clinical-trial-remote-services), [fda](https://blog.harborclinical.com/blog/tag/fda), [inspection readiness](https://blog.harborclinical.com/blog/tag/inspection-readiness), [Data Management](https://blog.harborclinical.com/blog/tag/data-management), [Clinical Research](https://blog.harborclinical.com/blog/tag/clinical-research), [Biotech](https://blog.harborclinical.com/blog/tag/biotech), [Pharmaceuticals](https://blog.harborclinical.com/blog/tag/pharmaceuticals), [biotechnology](https://blog.harborclinical.com/blog/tag/biotechnology), [pharma](https://blog.harborclinical.com/blog/tag/pharma), [qualityassurance](https://blog.harborclinical.com/blog/tag/qualityassurance), [Quality Assurance](https://blog.harborclinical.com/blog/tag/quality-assurance), [biostatistics](https://blog.harborclinical.com/blog/tag/biostatistics), [biometrics](https://blog.harborclinical.com/blog/tag/biometrics), [FSP](https://blog.harborclinical.com/blog/tag/fsp), [Functional Service Provider](https://blog.harborclinical.com/blog/tag/functional-service-provider), [clinical trials](https://blog.harborclinical.com/blog/tag/clinical-trials), [project management](https://blog.harborclinical.com/blog/tag/project-management), [data operations](https://blog.harborclinical.com/blog/tag/data-operations), [Good Clinical Practice](https://blog.harborclinical.com/blog/tag/good-clinical-practice), [patient enrollment](https://blog.harborclinical.com/blog/tag/patient-enrollment), [patient recruitment](https://blog.harborclinical.com/blog/tag/patient-recruitment), [clinical research jobs](https://blog.harborclinical.com/blog/tag/clinical-research-jobs), [clinical outsourcing](https://blog.harborclinical.com/blog/tag/clinical-outsourcing), [FDA inspections](https://blog.harborclinical.com/blog/tag/fda-inspections), [biopharma](https://blog.harborclinical.com/blog/tag/biopharma), [biomedical research](https://blog.harborclinical.com/blog/tag/biomedical-research), [medical research](https://blog.harborclinical.com/blog/tag/medical-research), [medical device manufacturer](https://blog.harborclinical.com/blog/tag/medical-device-manufacturer), [food and drug administration](https://blog.harborclinical.com/blog/tag/food-and-drug-administration), [patients](https://blog.harborclinical.com/blog/tag/patients), [medical patients](https://blog.harborclinical.com/blog/tag/medical-patients), [budget](https://blog.harborclinical.com/blog/tag/budget), [clinical research data management](https://blog.harborclinical.com/blog/tag/clinical-research-data-management), [great resignation](https://blog.harborclinical.com/blog/tag/great-resignation), [staff shortage](https://blog.harborclinical.com/blog/tag/staff-shortage), [quality data](https://blog.harborclinical.com/blog/tag/quality-data) ## [5 Best Practices for Maintaining a Trial Master File (TMF)](https://blog.harborclinical.com/blog/tmf) Posted by [Chad Birt](https://blog.harborclinical.com/blog/author/chad-birt) on Jul 12, 2022 7:45:00 AM - [Tweet](https://twitter.com/share) [![clinical trial TMF ](https://blog.harborclinical.com/hubfs/trial.jpg)](https://blog.harborclinical.com/blog/tmf) 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](https://blog.harborclinical.com/blog/tmf) 0 Comments [Click here to read/write comments](https://blog.harborclinical.com/blog/tmf#comments-listing) Topics: [clinical trial](https://blog.harborclinical.com/blog/tag/clinical-trial), [clinical trial strategic planning](https://blog.harborclinical.com/blog/tag/clinical-trial-strategic-planning), [clinical trial consulting](https://blog.harborclinical.com/blog/tag/clinical-trial-consulting), [clinical trial remote services](https://blog.harborclinical.com/blog/tag/clinical-trial-remote-services), [fda](https://blog.harborclinical.com/blog/tag/fda), [inspection readiness](https://blog.harborclinical.com/blog/tag/inspection-readiness), [Data Management](https://blog.harborclinical.com/blog/tag/data-management), [Clinical Research](https://blog.harborclinical.com/blog/tag/clinical-research), [Biotech](https://blog.harborclinical.com/blog/tag/biotech), [Pharmaceuticals](https://blog.harborclinical.com/blog/tag/pharmaceuticals), [biotechnology](https://blog.harborclinical.com/blog/tag/biotechnology), [pharma](https://blog.harborclinical.com/blog/tag/pharma), [qualityassurance](https://blog.harborclinical.com/blog/tag/qualityassurance), [Quality Assurance](https://blog.harborclinical.com/blog/tag/quality-assurance), [biostatistics](https://blog.harborclinical.com/blog/tag/biostatistics), [biometrics](https://blog.harborclinical.com/blog/tag/biometrics), [FSP](https://blog.harborclinical.com/blog/tag/fsp), [Functional Service Provider](https://blog.harborclinical.com/blog/tag/functional-service-provider), [clinical trials](https://blog.harborclinical.com/blog/tag/clinical-trials), [project management](https://blog.harborclinical.com/blog/tag/project-management), [Good Clinical Practice](https://blog.harborclinical.com/blog/tag/good-clinical-practice), [patient enrollment](https://blog.harborclinical.com/blog/tag/patient-enrollment), [patient recruitment](https://blog.harborclinical.com/blog/tag/patient-recruitment), [clinical research jobs](https://blog.harborclinical.com/blog/tag/clinical-research-jobs), [clinical outsourcing](https://blog.harborclinical.com/blog/tag/clinical-outsourcing), [FDA inspections](https://blog.harborclinical.com/blog/tag/fda-inspections), [biopharma](https://blog.harborclinical.com/blog/tag/biopharma), [biomedical research](https://blog.harborclinical.com/blog/tag/biomedical-research), [medical research](https://blog.harborclinical.com/blog/tag/medical-research), [medical device manufacturer](https://blog.harborclinical.com/blog/tag/medical-device-manufacturer), [food and drug administration](https://blog.harborclinical.com/blog/tag/food-and-drug-administration), [patients](https://blog.harborclinical.com/blog/tag/patients), [medical patients](https://blog.harborclinical.com/blog/tag/medical-patients), [budget](https://blog.harborclinical.com/blog/tag/budget), [TMF](https://blog.harborclinical.com/blog/tag/tmf), [trial master file](https://blog.harborclinical.com/blog/tag/trial-master-file) ## [How to Keep Your Clinical Trial On (Or Under) Budget](https://blog.harborclinical.com/blog/budget) Posted by [Chad Birt](https://blog.harborclinical.com/blog/author/chad-birt) on Jun 7, 2022 7:30:00 AM - [Tweet](https://twitter.com/share) [![](https://blog.harborclinical.com/hubfs/trial.jpg)](https://blog.harborclinical.com/blog/budget) Designing and implementing clinical trials isn’t cheap. [One report](https://aspe.hhs.gov/sites/default/files/private/pdf/77166/rpt_erg.pdf) 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](https://blog.harborclinical.com/blog/budget) 1 Comment [Click here to read/write comments](https://blog.harborclinical.com/blog/budget#comments-listing) Topics: [clinical trial](https://blog.harborclinical.com/blog/tag/clinical-trial), [clinical trial strategic planning](https://blog.harborclinical.com/blog/tag/clinical-trial-strategic-planning), [clinical trial consulting](https://blog.harborclinical.com/blog/tag/clinical-trial-consulting), [clinical trial remote services](https://blog.harborclinical.com/blog/tag/clinical-trial-remote-services), [fda](https://blog.harborclinical.com/blog/tag/fda), [inspection readiness](https://blog.harborclinical.com/blog/tag/inspection-readiness), [Data Management](https://blog.harborclinical.com/blog/tag/data-management), [Clinical Research](https://blog.harborclinical.com/blog/tag/clinical-research), [Biotech](https://blog.harborclinical.com/blog/tag/biotech), [Pharmaceuticals](https://blog.harborclinical.com/blog/tag/pharmaceuticals), [biotechnology](https://blog.harborclinical.com/blog/tag/biotechnology), [pharma](https://blog.harborclinical.com/blog/tag/pharma), [qualityassurance](https://blog.harborclinical.com/blog/tag/qualityassurance), [Quality Assurance](https://blog.harborclinical.com/blog/tag/quality-assurance), [biostatistics](https://blog.harborclinical.com/blog/tag/biostatistics), [biometrics](https://blog.harborclinical.com/blog/tag/biometrics), [FSP](https://blog.harborclinical.com/blog/tag/fsp), [Functional Service Provider](https://blog.harborclinical.com/blog/tag/functional-service-provider), [clinical trials](https://blog.harborclinical.com/blog/tag/clinical-trials), [project management](https://blog.harborclinical.com/blog/tag/project-management), [Good Clinical Practice](https://blog.harborclinical.com/blog/tag/good-clinical-practice), [patient enrollment](https://blog.harborclinical.com/blog/tag/patient-enrollment), [patient recruitment](https://blog.harborclinical.com/blog/tag/patient-recruitment), [clinical research jobs](https://blog.harborclinical.com/blog/tag/clinical-research-jobs), [clinical outsourcing](https://blog.harborclinical.com/blog/tag/clinical-outsourcing), [FDA inspections](https://blog.harborclinical.com/blog/tag/fda-inspections), [biopharma](https://blog.harborclinical.com/blog/tag/biopharma), [biomedical research](https://blog.harborclinical.com/blog/tag/biomedical-research), [medical research](https://blog.harborclinical.com/blog/tag/medical-research), [medical device manufacturer](https://blog.harborclinical.com/blog/tag/medical-device-manufacturer), [food and drug administration](https://blog.harborclinical.com/blog/tag/food-and-drug-administration), [patients](https://blog.harborclinical.com/blog/tag/patients), [medical patients](https://blog.harborclinical.com/blog/tag/medical-patients), [budget](https://blog.harborclinical.com/blog/tag/budget) ## [Tips for Improving the Patient Experience in Clinical Trials](https://blog.harborclinical.com/blog/patientexperience) Posted by [Chad Birt](https://blog.harborclinical.com/blog/author/chad-birt) on May 3, 2022 7:36:00 AM - [Tweet](https://twitter.com/share) [![](https://blog.harborclinical.com/hubfs/doc.jpg)](https://blog.harborclinical.com/blog/patientexperience) Low patient retention is one of the greatest challenges that clinical researchers face. [One study](https://www.centerwatch.com/articles/24543-recruitment-rates-rising-but-retention-rates-fall-according-to-new-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](https://blog.harborclinical.com/blog/patientexperience) 0 Comments [Click here to read/write comments](https://blog.harborclinical.com/blog/patientexperience#comments-listing) Topics: [clinical trial](https://blog.harborclinical.com/blog/tag/clinical-trial), [clinical trial strategic planning](https://blog.harborclinical.com/blog/tag/clinical-trial-strategic-planning), [clinical trial consulting](https://blog.harborclinical.com/blog/tag/clinical-trial-consulting), [clinical trial remote services](https://blog.harborclinical.com/blog/tag/clinical-trial-remote-services), [fda](https://blog.harborclinical.com/blog/tag/fda), [inspection readiness](https://blog.harborclinical.com/blog/tag/inspection-readiness), [Data Management](https://blog.harborclinical.com/blog/tag/data-management), [Clinical Research](https://blog.harborclinical.com/blog/tag/clinical-research), [Biotech](https://blog.harborclinical.com/blog/tag/biotech), [Pharmaceuticals](https://blog.harborclinical.com/blog/tag/pharmaceuticals), [biotechnology](https://blog.harborclinical.com/blog/tag/biotechnology), [pharma](https://blog.harborclinical.com/blog/tag/pharma), [qualityassurance](https://blog.harborclinical.com/blog/tag/qualityassurance), [Quality Assurance](https://blog.harborclinical.com/blog/tag/quality-assurance), [biostatistics](https://blog.harborclinical.com/blog/tag/biostatistics), [biometrics](https://blog.harborclinical.com/blog/tag/biometrics), [FSP](https://blog.harborclinical.com/blog/tag/fsp), [Functional Service Provider](https://blog.harborclinical.com/blog/tag/functional-service-provider), [clinical trials](https://blog.harborclinical.com/blog/tag/clinical-trials), [project management](https://blog.harborclinical.com/blog/tag/project-management), [Good Clinical Practice](https://blog.harborclinical.com/blog/tag/good-clinical-practice), [patient enrollment](https://blog.harborclinical.com/blog/tag/patient-enrollment), [patient recruitment](https://blog.harborclinical.com/blog/tag/patient-recruitment), [clinical research jobs](https://blog.harborclinical.com/blog/tag/clinical-research-jobs), [clinical outsourcing](https://blog.harborclinical.com/blog/tag/clinical-outsourcing), [FDA inspections](https://blog.harborclinical.com/blog/tag/fda-inspections), [biopharma](https://blog.harborclinical.com/blog/tag/biopharma), [biomedical research](https://blog.harborclinical.com/blog/tag/biomedical-research), [medical research](https://blog.harborclinical.com/blog/tag/medical-research), [medical device manufacturer](https://blog.harborclinical.com/blog/tag/medical-device-manufacturer), [food and drug administration](https://blog.harborclinical.com/blog/tag/food-and-drug-administration), [patients](https://blog.harborclinical.com/blog/tag/patients), [medical patients](https://blog.harborclinical.com/blog/tag/medical-patients) ## [Introducing Our Functionally Aligned Strategic Team (FAST™)](https://blog.harborclinical.com/blog/fast) Posted by [Chad Birt](https://blog.harborclinical.com/blog/author/chad-birt) on Mar 28, 2022 7:59:00 AM - [Tweet](https://twitter.com/share) [![Harbor Clinical logo](https://blog.harborclinical.com/hubfs/HC-linkedin-3.png)](https://blog.harborclinical.com/blog/fast) 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. [Read More](https://blog.harborclinical.com/blog/fast) 0 Comments [Click here to read/write comments](https://blog.harborclinical.com/blog/fast#comments-listing) Topics: [clinical trial](https://blog.harborclinical.com/blog/tag/clinical-trial), [clinical trial strategic planning](https://blog.harborclinical.com/blog/tag/clinical-trial-strategic-planning), [clinical trial consulting](https://blog.harborclinical.com/blog/tag/clinical-trial-consulting), [clinical trial remote services](https://blog.harborclinical.com/blog/tag/clinical-trial-remote-services), [fda](https://blog.harborclinical.com/blog/tag/fda), [inspection readiness](https://blog.harborclinical.com/blog/tag/inspection-readiness), [Data Management](https://blog.harborclinical.com/blog/tag/data-management), [Clinical Research](https://blog.harborclinical.com/blog/tag/clinical-research), [Biotech](https://blog.harborclinical.com/blog/tag/biotech), [Pharmaceuticals](https://blog.harborclinical.com/blog/tag/pharmaceuticals), [biotechnology](https://blog.harborclinical.com/blog/tag/biotechnology), [pharma](https://blog.harborclinical.com/blog/tag/pharma), [qualityassurance](https://blog.harborclinical.com/blog/tag/qualityassurance), [Quality Assurance](https://blog.harborclinical.com/blog/tag/quality-assurance), [biostatistics](https://blog.harborclinical.com/blog/tag/biostatistics), [biometrics](https://blog.harborclinical.com/blog/tag/biometrics), [FSP](https://blog.harborclinical.com/blog/tag/fsp), [Functional Service Provider](https://blog.harborclinical.com/blog/tag/functional-service-provider), [clinical trials](https://blog.harborclinical.com/blog/tag/clinical-trials), [project management](https://blog.harborclinical.com/blog/tag/project-management), [Good Clinical Practice](https://blog.harborclinical.com/blog/tag/good-clinical-practice), [clinical research jobs](https://blog.harborclinical.com/blog/tag/clinical-research-jobs), [clinical outsourcing](https://blog.harborclinical.com/blog/tag/clinical-outsourcing), [FDA inspections](https://blog.harborclinical.com/blog/tag/fda-inspections), [biopharma](https://blog.harborclinical.com/blog/tag/biopharma), [biomedical research](https://blog.harborclinical.com/blog/tag/biomedical-research), [medical research](https://blog.harborclinical.com/blog/tag/medical-research), [medical device manufacturer](https://blog.harborclinical.com/blog/tag/medical-device-manufacturer), [food and drug administration](https://blog.harborclinical.com/blog/tag/food-and-drug-administration) ## [5 Tips for Establishing a Healthy Relationship with your CRO](https://blog.harborclinical.com/blog/cro) Posted by [Chad Birt](https://blog.harborclinical.com/blog/author/chad-birt) on May 26, 2021 8:00:00 AM - [Tweet](https://twitter.com/share) [![](https://blog.harborclinical.com/hubfs/pexels-fauxels-3184416.jpg)](https://blog.harborclinical.com/blog/cro) A recent [investigation](https://jamanetwork.com/journals/jama/article-abstract/2762311) published by JAMA found that the average cost of bringing a new drug to market is $1.3 billion. Considering only 12% of new pharmaceuticals receive FDA approval, developing these products requires large amounts of money and even more risk. [Read More](https://blog.harborclinical.com/blog/cro) 0 Comments [Click here to read/write comments](https://blog.harborclinical.com/blog/cro#comments-listing) Topics: [Clinical Research](https://blog.harborclinical.com/blog/tag/clinical-research), [Pharmaceuticals](https://blog.harborclinical.com/blog/tag/pharmaceuticals), [clinical outsourcing](https://blog.harborclinical.com/blog/tag/clinical-outsourcing) [All posts](https://blog.harborclinical.com/blog/all) ## 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. 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