Product/Service

Harbor Clinical FSP Model: Functional, Flexible, Fractional

Field Service Partner Management

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.

Functional

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.

Flexible

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.

Fractional

Unlike many FSP providers, Harbor Clinical allows for “fractional sourcing” — use of part-time team members available for rapid redeployment. We staff your project from a global database of known, vetted, and/or trusted experts in many clinical research functions.

Services

Quality Assurance

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.

Vendor Oversight

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!”

Biometrics

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.

Clinical Operations

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.

Medical Writing

With average industry experience exceeding 10 years, each member of our Medical Writing team is uniquely qualified to meet all of your needs. Whether it is a Study Protocol, Clinical Study Report, IND Submission Support, or other requirement, we have a Medical Writer that’s perfectly suited for the job.

Regulatory Affairs

Harbor Clinical provides strategic and operational services for drug and device development programs through all clinical phases, from preclinical to post-marketing.

Strategic Development

Harbor Clinical provides clinical trial planning services for early-stage biotechnology companies, helping them prepare for clinical milestones such as entry into the clinic or pipeline progression. These services supplement the scientific and business teams, providing guidance in navigating the clinical and regulatory landscape to ultimately move the product into the clinic. Clinical trial planning encompasses the creation of a clinical development plan, prescribed timelines and a roadmap for entering the clinic, as well as budgeting for the vendors and resources needed to execute the plan.