Quality Control and Indexing of Essential Clinical Trial Documents for Stryker Neurovascular products and configuring the payments of the clinical trials

Abstract

The study focuses on the clinical functions within the Stryker Neurovascular division. Conducting clinical trials can be complex and time-consuming, but a Clinical Trial Management System (CTMS) can streamline the process, making it more efficient and cost-effective. CTMS is applica- ble across all four phases of a clinical trial and is utilized by research sites, institutions, sponsors, and contract research organizations (CROs) to ensure the success of their studies. There are numerous reasons why CTMS is crucial: it saves time and reduces frustration throughout a study by providing easy access to up-to-date progress reports, allowing study leaders to plan and assign tasks, track and monitor activities, organize all relevant documents and information, manage various assets and associated trials, and facilitate compliance with regulatory requirements. As part of implementing CTMS, Stryker launched Project SWIFT to onboard multiple studies, along with their electronic data capture systems, electronic trial master file, and the invoicing and payment processes for clinical sites using the CTMS module. This project involved configuring the payments and invoicing module, which was assigned as an internship project and served as the ba- sis for this thesis.