Harbor Clinical has redefined the FSP service model, adding enhanced flexibility in timing, scope, and level of resources assigned. Functional, Flexible, and Fractional. Harbor Clinical provides a broad portfolio of services across the clinical development lifecycle.
Each sponsor is unique, so in each case we design a function-based outsourcing model that provides the degree of daily oversight with which you are comfortable. Leading each FSP integration at Harbor Clinical is a dedicated FSP Manager who serves as a point of coordination to the sponsor and the employees assigned, allowing you to concentrate on turning innovative ideas into breakthrough medical advances.
Today more than ever, sponsors, large and small, need flexibility in staffing their clinical trials. Our functional service provider model offers that flexibility and drives down cost by applying resources where and when they’re needed, limiting the need to recruit and train employees and minimizing exposure to risk. FSP agreements adjust to the ebb and flow of study workloads, quickly deploying top-tier expertise as demands change.
Harbor Clinical specializes in delivering our clients a portfolio of GxP Quality Assurance services to ensure regulatory compliance. We work closely with our clients to tailor a compliance and quality assurance solution according to their needs, whether it is developing an internal Quality Management System and infrastructure or providing QA auditing services.
Harbor Clinical understands that while a sponsor can transfer trial related duties to a CRO, the sponsor maintains the ultimate responsibility for the quality and integrity of clinical trial data. Harbor Clinical’s vendor oversight services are structured to incorporate quality control throughout the process, overseeing QC checks at each step of data handling to ensure success. We subscribe to the motto “an ounce of prevention is certainly worth a pound of cure!”
Our specialists bring extensive programming experience and expertise to support your study needs in a variety of EDC platforms, including Medidata RAVE, Oracle Inform, Datalabs, Medrio and IBM Health, among others.
Harbor Clinical provides all Biometrics support including Biostatistics, Clinical Programming, Data Management, Medical Coding, and Database Development.
Whether you need oversight monitors or a team of CTMs, CRAs, and CTAs, Harbor Clinical will quickly assemble a Clinical Operations team to meet your needs and exceed your expectations. From study start-up to close-out, your operational needs can be supported with a team of Harbor Clinical professionals who understand the regulatory role they play to ensure you are compliant in all functions.
Harbor Clinical provides strategic and operational services for drug and device development programs through all clinical phases, from preclinical to post-marketing.
Functionally Aligned Strategic Team. We act quickly to assemble your dream team. Our process is optimized to save you time and money while providing top-tier service.
Harbor Clinical’s team of GxP auditors is available to help you plan, schedule, manage, and conduct your site/vendor audits.
Discover how Harbor Clinical can assist your company.
Committed to quality. Committed to you.