Novella Clinical’s global safety management and pharmacovigilance expertise allows us to tailor support to each customer’s needs, as well as perform Safety Event (e.g., SAE, UADE) collection and processing on various study types and sizes.
Our highly skilled Safety Processing team uses electronic processes and workflows, eliminating the time and expense of maintaining paper files, reducing processing time and lowering the risk associated with storing documents across multiple locations. We centrally receive and process safety event information utilizing the latest validated Oracle® Argus Safety Database, which enables regulatory compliance and compliance metrics along all workflow steps.
Our dedicated Safety Reporting team ensures independent unblinding, if required, and timely submission to Regulatory Authorities and Central Ethics Committees/IRBs worldwide. Submissions are typically tracked centrally in the Safety Database to allow for end-to-end case metrics and compliance monitoring.
With regular reconciliation between safety and clinical databases, we can quickly compare patient safety profile listings throughout the life of the study. This reduces end-of-study reconciliation time, which is particularly beneficial on longer and high-volume studies.
Novella’s global Safety Services are offered as part of a full service contract or as a standalone program. “Safety Only” services offer high efficiencies, since there is only minimal cost increase for additional protocols added.
Safety Management Services Include:
- Consulting and management planning, e.g., for transition from existing vendor
- Protocol safety section development including SAE forms
- Investigator/site training
- Data transfers and legacy database migration
- Full data entry in client’s safety databases
- Intake, triage and data entry in Novella’s Argus Safety Database
- Regulatory dictionary coding (e.g., MedDRA)
- Review and preliminary assessment of all Safety Event types
- Safety event narratives
- Follow-up/queries to sites until case closure
- Support of reconciliation
- Preparation of forms for expedited reporting
- Distribution and submission of reportable events, electronic or as per local regulation
- Submission of periodic reports (e.g., DSUR), electronic or as per local regulations
- Safety regulatory intelligence support
- Custom safety event listings and reports
- Generation of listings for periodic reports