Clin-Assist specializes in early medical device development, providing a broad range of support services including strategy and execution of First-in-Human clinical trials and early phase studies, as well as non-clinical (pre-clinical) consulting services.

Clin-Assist provides full services typical of a CRO, but as part of the client’s expanded team, stepping in as a fully functional Clinical Affairs department. We customize our goals and approach to the needs of the project, the client, and the technology.

Clin-Assist has extensive experience partnering with clients in support of regulatory applications, submissions, study reporting, development, and coordination of clinical and regulatory strategy(ies).

Clin-Assist can help your company with the development of your own clinical quality systems; we also provide auditing services, clinical study clean-up, and other Quality Assurance services. We have designed an established and proven quality system that can be leveraged by clients. As with our Clinical and Regulatory services, Clin-Assist is able to customize services to meet the project's specific needs.

Our Data Management team's structure is responsive and adaptable, from initial establishment of a new system, to providing full-service database development and management. We partner with an Electronic Data Capture (EDC) vendor to help reduce costs, and a dedicated database programmer to ensure that study data can be gathered efficiently and securely.

Clin-Assist's proactive risk-based monitoring ensures the overall health of your study and the quality of its data. Utilizing a combination of on-site and remote desktop monitoring helps with early identification of challenges with regulatory files, reporting, site/investigator compliance, and data integrity which allows us to course correct before issues can affect the viability of the study.

Clin-Assist can help with overall set-up and management of study committees such as Clinical Events Committees, Data and Safety Monitoring Boards, independent physician reviewer(s), core labs and other research organizations.

Clin-Assist acts as a fully-operational Clinical Affairs department and is often hired as a management resource to oversee other contracted contract research organizations.

Clin-Assist provides customized training from entry level positions to company executives interested in understanding top-line resources and requirements for execution of a clinical trial.

Clin-Assist has effectively rescued multiple clinical studies, resulting in positive outcomes for clients. We utilize our extensive experience in the assessment of trial design and execution. Our guidance in addressing non-compliance issues ensures that regulatory submissions includes clean and relevant study data.

Clin-Assist modifies each recruitment effort to meet study needs. From advertising to on-line screening to active screening and confirmation of eligibility, we can provide a robust recruitment program or assist in specific recruitment efforts.

For clinical sites, Clin-Assist provides support from training to acting as a fully operational central coordination center.