ABOUT HARBOR CLINICAL
Harbor Clinical is a women-owned clinical research services firm with headquarters in the Boston biotech area. As a Functional Service Provider (FSP) offering Staff Augmentation, Consulting, and Single-Service resourcing models, Harbor Clinical's mission is based on the goal of forging innovative partnerships, with sponsors and employees, built on a bedrock of communication and transparency. Our collaboration with our clients is ongoing, allowing us to provide the right solution at the right time that is flexible and scalable. Founded as a Quality Assurance services firm, quality is embedded in everything we do. Our experienced professionals are aligned therapeutically and operationally with your needs and work either remotely or in your office, depending on your company’s culture and requirements.
Our core competencies include:
- Quality Assurance (Inspection Readiness, site/vendor audits, etc)
- Vendor Oversight
- Clinical Operations
- Data Management
- Medical and Safety Management
- Medical Writing
See how this unique GxP auditing approach can ensure that vendors are complying with all rules and regulations quickly and efficiently, benefiting sponsors and auditors alike.
Read along as this author sheds light on the top three common barriers to clinical trial enrollment and offers a fundamental framework for overcoming these challenges.
Delve into several key benefits of entrusting pharmacovigilance needs to a qualified vendor, from economic efficiency and access to expertise to ensuring regulatory compliance and patient safety, and more.
When engaged with, patient advocacy organizations can be an invaluable resource. Delve into various strategies for establishing trust and long-lasting relationships with PAOs.
Clinical trial fraud is a prevalent issue that demands attention. Review several strategies for upholding due diligence and substantially reducing the risk of fraud in clinical trials.
Examine the merits associated with the strategic pairing of two distinct contract resource organizations: one focused on clinical requirements and the other specialized in biometrics.
Learn how partnering with an experienced functional service provider can help evaluate, implement, and integrate a QMS system while allowing core teams to stay on task.
Gain a better understanding of how trials are designed and carried out with patient safety at the top of mind.
Ever think about terminating your CRO contract? Delve into the reasons why you might, the potential implications, and the strategies for a successful exit and transition process.
Take a closer look at the FDA's draft guidance on designing and implementing DCTs, notably remote trial visits, the use of digital health technologies, institutional review board oversight, and more.