Functional Service Provision

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.

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.

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

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.