CG Products Bucket
-
Clinical Operations
1/13/2021
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.
-
Site Management And Clinical Monitoring
1/13/2021
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.
-
Medical Writing
1/13/2021
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.
-
Quality Control
1/13/2021
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.
-
Regulatory Operations
1/13/2021
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.
-
Quality Assurance
1/13/2021
We establish quality structures and streamlined approaches to reduce risk and reinforce operational innovation in the changing landscape of clinical quality and compliance.
-
Electronic Trial Master File (eTMF)
1/13/2021
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.
-
Biostatistical Services And Programming
1/13/2021
Ensure proper collection, verification, and delivery of Clinical Trial data through collaborative partnerships.
-
Faciliflex Cleanroom Module For Drug Manufacturing
1/12/2021
Faciliflex Module offers the ultimate flexibility in cleanroom design—pre-configured, modular “base blocks” that allow you to mix-and-match all the components you need for your next cleanroom facility.
-
RoSS.FILL
1/4/2021
RoSS.FILL is a flexible platform for the allocation and distribution of bulk drug substance in single use bags that are integrated in the RoSS® system. The liquid path is fully disposable and can accommodate a multitude of sterile compound- and segregation options.