Provide end-to-end support and efficient solutions for every stage of the clinical trial lifecycle, including pre-study, startup, maintenance, reporting, and close-out services to support all clinical study needs. Our Clinical Operations subject matter experts are integrated into the client’s project team, thus ensuring a more streamlined approach to providing the required support and/or recommending ways to achieve new efficiencies.

Our Regional Site Managers (RSMs) are recapturing the importance of building relationships with clinical sites. Our RSMs can act as a “one-stop shop” for all activities related to a clinical study site.

We author documents that support research and development and marketing needs.  Our expertise includes clinical study protocols, clinical study reports, Investigator’s brochures, briefing documents, safety narratives, and Modules 2 to 5 of the CTD.

We fact-check and substantiate clinical study data and review punctuation, syntax, semantic errors, clarity of presentation, and consistency. We collaborate with the client to customize the QC process and checklist.

Provide seamless collaboration on documents and submissions throughout a spectrum of services: medical writing, quality control review, document- and submission-level publishing, and health authority submission management.

We establish quality structures and streamlined approaches to reduce risk and reinforce operational innovation in the changing landscape of clinical quality and compliance.

We utilize Vault eTMF (Veeva Systems, Inc.) to provide unique and scalable solutions to maintain our clients’ eTMF with inspection-readiness practices incorporated into daily operations.

Ensure proper collection, verification, and delivery of Clinical Trial data through collaborative partnerships.