--- title: Harbor Clinical Blog | biotechnology description: biotechnology | 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 ## [FDA Finalizes Historic Rule Providing Access to Over-the-Counter Hearing Aids](https://blog.harborclinical.com/blog/hearingaids) Posted by [Chad Birt](https://blog.harborclinical.com/blog/author/chad-birt) on Sep 6, 2022 7:00:00 AM - [Tweet](https://twitter.com/share) [![Hearing aid ](https://blog.harborclinical.com/hubfs/hearaid.jpg)](https://blog.harborclinical.com/blog/hearingaids) 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.  [Read More](https://blog.harborclinical.com/blog/hearingaids) 1 Comment [Click here to read/write comments](https://blog.harborclinical.com/blog/hearingaids#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), [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), [biostatistics](https://blog.harborclinical.com/blog/tag/biostatistics), [biometrics](https://blog.harborclinical.com/blog/tag/biometrics), [FSP](https://blog.harborclinical.com/blog/tag/fsp), [clinical trials](https://blog.harborclinical.com/blog/tag/clinical-trials), [online meetings](https://blog.harborclinical.com/blog/tag/online-meetings), [project management](https://blog.harborclinical.com/blog/tag/project-management), [Good Clinical Practice](https://blog.harborclinical.com/blog/tag/good-clinical-practice), [healthy living](https://blog.harborclinical.com/blog/tag/healthy-living), [patient enrollment](https://blog.harborclinical.com/blog/tag/patient-enrollment), [FDA inspections](https://blog.harborclinical.com/blog/tag/fda-inspections), [medical research](https://blog.harborclinical.com/blog/tag/medical-research), [food and drug administration](https://blog.harborclinical.com/blog/tag/food-and-drug-administration), [medical patients](https://blog.harborclinical.com/blog/tag/medical-patients) ## [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) ## [Everything You Need to Know About the FDA’s Proposed Benefit-Risk Assessment for New Drug and Biological Products](https://blog.harborclinical.com/blog/fdaassessment) Posted by [Chad Birt](https://blog.harborclinical.com/blog/author/chad-birt) on Mar 4, 2022 10:00:00 AM - [Tweet](https://twitter.com/share) [![](https://blog.harborclinical.com/hubfs/fda_headquarter_istock_1213293784.jpeg)](https://blog.harborclinical.com/blog/fdaassessment) 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.  [Read More](https://blog.harborclinical.com/blog/fdaassessment) 0 Comments [Click here to read/write comments](https://blog.harborclinical.com/blog/fdaassessment#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), [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), [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), [FDA inspections](https://blog.harborclinical.com/blog/tag/fda-inspections), [supply chain](https://blog.harborclinical.com/blog/tag/supply-chain), [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), [supply chain management](https://blog.harborclinical.com/blog/tag/supply-chain-management), [medical device manufacturer](https://blog.harborclinical.com/blog/tag/medical-device-manufacturer), [supply chain shortage](https://blog.harborclinical.com/blog/tag/supply-chain-shortage), [food and drug administration](https://blog.harborclinical.com/blog/tag/food-and-drug-administration) ## [Rare Disease Day 2022: How The Pharmaceutical Industry Has Stepped Up and Tips for Bringing Treatments to Market](https://blog.harborclinical.com/blog/rarediseaseday2022) Posted by [Chad Birt](https://blog.harborclinical.com/blog/author/chad-birt) on Jan 25, 2022 8:00:00 AM - [Tweet](https://twitter.com/share) [![](https://blog.harborclinical.com/hubfs/raredisease.jpeg)](https://blog.harborclinical.com/blog/rarediseaseday2022) 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. [Read More](https://blog.harborclinical.com/blog/rarediseaseday2022) 0 Comments [Click here to read/write comments](https://blog.harborclinical.com/blog/rarediseaseday2022#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), [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), [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), [supply chain](https://blog.harborclinical.com/blog/tag/supply-chain), [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), [supply chain management](https://blog.harborclinical.com/blog/tag/supply-chain-management), [medical device manufacturer](https://blog.harborclinical.com/blog/tag/medical-device-manufacturer), [supply chain shortage](https://blog.harborclinical.com/blog/tag/supply-chain-shortage), [rare disease awareness](https://blog.harborclinical.com/blog/tag/rare-disease-awareness), [rare diseases](https://blog.harborclinical.com/blog/tag/rare-diseases), [genetic diseases](https://blog.harborclinical.com/blog/tag/genetic-diseases) ## [What Medical Device Manufacturers and Biopharmas Can Do to Reduce Supply Chain Headaches](https://blog.harborclinical.com/blog/supplychain) Posted by [Chad Birt](https://blog.harborclinical.com/blog/author/chad-birt) on Dec 14, 2021 9:00:00 AM - [Tweet](https://twitter.com/share) [![covid ](https://blog.harborclinical.com/hubfs/supplychain.jpeg)](https://blog.harborclinical.com/blog/supplychain) For [more than a year](https://www.businessinsider.com/supply-chain-crisis-when-it-will-be-over-end-2021-11) 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.  [Read More](https://blog.harborclinical.com/blog/supplychain) 0 Comments [Click here to read/write comments](https://blog.harborclinical.com/blog/supplychain#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), [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), [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), [supply chain](https://blog.harborclinical.com/blog/tag/supply-chain), [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), [supply chain management](https://blog.harborclinical.com/blog/tag/supply-chain-management), [medical device manufacturer](https://blog.harborclinical.com/blog/tag/medical-device-manufacturer), [supply chain shortage](https://blog.harborclinical.com/blog/tag/supply-chain-shortage) ## [5 Clinical Trial Trends for 2022](https://blog.harborclinical.com/blog/2022trends) Posted by [Chad Birt](https://blog.harborclinical.com/blog/author/chad-birt) on Nov 23, 2021 8:26:00 AM - [Tweet](https://twitter.com/share) [![2022 calendar goals ](https://blog.harborclinical.com/hubfs/pexels-towfiqu-barbhuiya-9976281-1.jpg)](https://blog.harborclinical.com/blog/2022trends) 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](https://blog.harborclinical.com/blog/2022trends) 1 Comment [Click here to read/write comments](https://blog.harborclinical.com/blog/2022trends#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), [data mangement](https://blog.harborclinical.com/blog/tag/data-mangement), [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), [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), [new years](https://blog.harborclinical.com/blog/tag/new-years), [patient enrollment](https://blog.harborclinical.com/blog/tag/patient-enrollment), [FDA inspections](https://blog.harborclinical.com/blog/tag/fda-inspections) [All posts](https://blog.harborclinical.com/blog/all) [Next](https://blog.harborclinical.com/blog/tag/biotechnology/page/2) ## 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. 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