The task was to conduct workshops, individual interviews, and review existing manual and automated process to determine the company’s needs for new electronic systems and/or modifications to existing systems and/or processes. Additionally, the systems were reviewed to ascertain the current regulatory validation and to provide a remediation plan in the event that the systems had not been sufficiently validated.
Mid-size device company (Clinical R&D), a subsidiary of a top global pharmaceutical company, involved in the conduct of global clinical trials (under IND Submissions in the US) using an approved, commercially available device in combination with an FDA-approved drug.
The predominant issue with the company was the manner in which essential documentation, monitoring reports, SAEs, and other clinical documentation was flowing from the investigators’ sites back to the sponsor and into the hands of the appropriate personnel and ultimately into the Master File. In addition to the documentation problem, Clinical Project Managers were experiencing difficulties with tracking investigator milestones and project deadlines due to the inefficiencies and unsophisticated tools.
Advarra Consulting conducted several workshops to determine the existing document workflows and lifecycles. Additionally, a document inventory was conducted to both determine the types and location of essential documentation.
Furthermore, a Clinical Trials Management System (CTMS) was proposed. The CTMS requirements were gathered (from individual interviews, workshops, etc.), and a Requirements document drafted. The Requirements were used in the production of an RFP to be sent to various CTMS vendors. Vendor responses were evaluated in conjunction with product presentations, and vendor audits. As a result, a product was chosen. The product is in the implementation phase with Advarra Consulting providing guidance and configuration consulting.