The current processes for generation, tracking and dissemination of CIOMS are ad-hoc, resource intensive and rely largely upon ad-hoc tools such as e-mails and excel spreadsheets. This is highly inefficient and is prone to error resulting in business liability and risk from an inspection and audit perspective. Managing distribution of information internally and external to CROs, partners and others based on Study, products and blinded/un-blinded access for organizations with portfolio of studies and products is complex. With constant resource changes, organizations are required to track and ensure access level are correctly granted and removed for inspection and audit purposes.
Quartica’s solution can play a key role in centralizing, tracking and dissemination of CIOMS information. It will eliminate manual steps thereby reducing the chance for delays or errors. The roles based access control will tightly regulate access based on study, product and blinded/unblinded access levels. The system will also allow organization to maintain user list and access level reports for audit and inspection purposes.
Centralized tracking and dissemination of daily CIOMS updates.
Personalized notifications to distribution groups based on roles based access level.
Standardization of terminology and automation of data-entry.
Real-time access to reports and metrics.
Self-service reports and CIOMS listings to users based on role.
Executive dashboard views and reporting of the distribution.
Audit trails for tracking, notifications, responses, and supporting data management operations.
Automate tracking, distribution and receipt of CIOMS to internal stakeholders, external CROs, partners and others.
Manage CIOMS, study and product attributes in a collaborative centralized system.
Facilitate compliance with audit and access level reports for inspection queries.
Generate reports and dashboards to view progress, distribution, receipt and regional conformance.
Please contact us for information or to schedule a demo