Investigator document submissions represent a critical milestone, including the FDA Form 1572, Primary Investigator (PI) Curriculum Vitae (CV), and a Financial Disclosure Form (FDF) for each investigator on the study. The 1572 and PI CV must be submitted within 30 days of the Drug Shipment Date, and compliance with this task using manual processes often results in delays. ArborSys consultants worked side-by-side with business and technology associates of a global pharmaceutical company to develop an electronic workflow for approval and submission of these investigator documents.
The SRD (Submission Regulatory Documents) 1572 Project Team focused on building quality into the process from the start and improving on-going regulatory document compliance. Business process experts were gathered from across the organization. Using ArborSys's structured approach, the existing processes were first documented and then new streamlined, harmonized processes were developed.
Utilizing the client's business process management (BPM) software, Appian, team members were able to quickly adapt new automated workflows to increase the timeliness of document submissions and the accuracy of study documents. The application monitors every step in the process in real-time, and makes individuals accountable for each task they accept. Additionally, the application will import data from the Clinical Trial Management System (CTMS) using an on-going data feed and then transfers documents to the regulatory repository after they have been processed.
Key performance metrics also were developed including: number of users and locations, connectivity and performance, document quality, and required rework.
The application is currently be used by personnel in charge of document submission and management activities (e.g., Clinical Research Associate, Clinical Project Leader, Regulatory Operations, etc.) for 2 clinical studies that include over 200 study sites.
The new application improved quality and regulatory compliance, while lowering the risk of non-compliance by providing traceability of documents for a study, and by creating a new standardized and automated process for the FDA 1572 forms, CVs, and FDFs delivering:
Major business goals achieved were:
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