Harbor Clinical Blog
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Harbor Clinical is a women-owned clinical research services organization based in Boston, offering services to Pharma, Biotech, CRO, and device companies. Our Blog presents simple strategies and advice on starting, handling, and improving the overall experience from a Clinical Trial site.
Harbor Clinical Blog
3w ago
What You Need to Know About the FDA and OHRP’s Joint Draft Guidance on Informed Consent in Clinical Trials All FDA-regulated clinical investigations of drugs, medical devices, and biologics require participants to give informed consent. Knowing a therapeutic’s potential ..read more
Harbor Clinical Blog
2M ago
Rare disease research has come a long way thanks in part to the passage of the Orphan Drug Act (ODA) of 1983. In the 40 years since, the biopharmaceutical industry has steadily increased its research and development efforts. Consider ..read more
Harbor Clinical Blog
2M ago
The last 12 months have been challenging for many in the biopharmaceutical space. Consider that industry layoffs increased 57% in 2023 compared to 2022. It’s amazing how quickly things change. During the COVID-19 pandemic, many of the same companies ..read more
Harbor Clinical Blog
4M ago
In October 2023, the FDA issued draft guidance on Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities. The document explains how the FDA operates its remote evaluation program and lays out expectations for the industry. Although remote ..read more
Harbor Clinical Blog
5M ago
Clinical trials are designed to determine if new drugs, therapies, and medical devices are safe and effective for public use. These interventions are tested on diverse patient populations to gain important insights, but a new report from the International ..read more
Harbor Clinical Blog
6M ago
3 Common Barriers to Clinical Trial Enrollment + Tips for Taking Action Despite all the good that clinical trials provide, patient enrollment is often an uphill battle. Consider that 80% of clinical trials fail to meet their enrollment ..read more
Harbor Clinical Blog
7M ago
Recruiting patients for clinical trials is an expensive and time-consuming process, taking about 18 months on average. It’s no surprise then that many biopharmas and medical device manufacturers are taking steps to speed things up and make patient recruitment ..read more
Harbor Clinical Blog
8M ago
Clinical trial fraud is not an uncommon problem. Though it is difficult to comprehend, it’s something that should not be ignored. Despite the problem, there is some hope. According to industry insiders, regulatory scrutiny is starting to ramp up ..read more
Harbor Clinical Blog
9M ago
Clinical trial safeguards have significantly improved over the last 50 years. The National Research Act, signed into law in 1974, established Institutional Review Boards (IRBs) to protect patients and increase public trust. In 1991, The Common Rule was adopted ..read more
Harbor Clinical Blog
10M ago
Clinical research plays an essential role in identifying and developing new drugs and therapeutics. Yet safety is such a major concern that most Americans say they wouldn’t feel comfortable enrolling. Consider that a recent survey conducted by researchers at ..read more