The Future of PVOPs Management
Establishing the capability to take informed decisions with well-orchestrated pharmacovigilance processes and unified communication will be a market differentiator for sponsors and affiliates.
To stay compliant with evolving safety and pharmacovigilance global regulations while working with multiple vendors, business partners, affiliates and service providers, sponsors are increasingly working towards developing risk-based operational intelligence with integrated and insightful digital PV process management.
PVSentinel is a process orchestration and compliance governance solution to
streamline, track and report the outcomes of PV operations and cross-functional
activities managed by different vendors, partners and affiliates.
What are the unique solution features available within PVSentinel?
Want to gain a holistic view on progress and outcomes?
With PVSentinel, you can now set up measurable program goals, redefine your success strategy, mobilize stakeholders, track performance and derive maximum value with continuous real-time program oversight.
Trouble with disconnected & manually tracked processes?
Eliminate process complexity and scale up productivity of your cross functional teams by streamlining all your core PV operational processes with digital workflows and decision controls using PVSentinel.
Are you dealing with Multiple Vendors, Systems & Trackers?
Plan, schedule, track and report all global PV related Case Reconciliation activities. All vendors and partners can submit periodic reconciliation reports across different programs and products. Get notified on activity progress and outcomes with a configurable status alert.
Want to reduce contractual agreement approval time?
Leverage the collaborative digital authoring, review and approval of all SDEAs and technical agreements with multiple affiliates, vendors and partners with electronic signatures. Use the document metadata to track, and report all changes with a built-in audit trail.
Trouble with inconsistent Vendor Coordination & Reporting?
PVSentinel allows sponsors to seamlessly track, report and identify opportunities for increasing Vendor compliance to quality agreements in real time. Strengthen transparent stakeholder relationships with continuous collaboration.
Facing difficulty to increase quality & mitigate compliance risks?
Conduct periodic quality assessments with pre-defined Key Quality Indicators (KQIs) and perform continuous risk monitoring based on configurable Key Risk Indicators (KRIs) to resolve open issues quickly across all program specific activities
Want to avoid preparation delays and pre-evaluate audit readiness?
Always stay ready for PV Audits & Inspections with pre-configured and scheduled inspection readiness assessment workflows. Identify and remediate critical issues by proactively tracking the status of all previous quality findings and CAPAs across each business function.
Thinking about simplifying PSMF management?
Leverage the ePSMF module to update all elements with automatic synchronization from process workflows. Closely monitor MAH compliance objectives and scrutinize periodic updates with alerts and reminders.
Want to Unify Stakeholder Communications?
Shorten the communication lifecycle between stakeholders by having a centralized inbox. You can send and receive critical process and activity updates with pre-configured templates and attachments directly from PVSentinel.
Lacking capability to make risk-based proactive decisions?
Stay informed and avoid missing or delaying critical events which can lead to process deviations, compliance shortfall and quality deficiencies with automatic system alerts and notifications.
Tired of searching and retrieving selective information from multiple systems?
With PVSentinel’s capability to integrate with your existing process systems such as QMS, LMS, Drug Safety, Contract management systems enable you to have selective information processed and readily available for identifying issues, decision making, risk and compliance monitoring
Define. Measure. Evaluate. Transform
Develop powerful operational intelligence and monitor trends of key performance indicators (KPIs), Key Risk Indicators (KRIs), Key Quality Indicators (KQIs) and Key Compliance Indicators (KCIs). Proactively identify non-compliance trends across Programs, Vendors, Partners and Processes
Renovate your PV processes with our powerful digital PV process collaboration platform.
Take risk-based informed decisions to be regulatory compliant and audit ready.
Empower stakeholder relationships with unified communication.
Key Solution Features & Benefits
With process digitalization, you can leverage PVSentinel to take informed decisions, monitor quality & risks and increase compliance proactively in the following areas:
- Vendor Oversight
- Aggregate Reporting
- Drug Approval Record
- Health Authority Monitoring
- REMS, RMP and RMM
- Literature Monitoring
- Contracts including SDEA
- Quality and CAPA
- Audits & Inspections
- SOP Adherence
What do we offer clients with PVSentinel?
Expertise for setting up PVSentinel system
integrations & business reports
24×7 Service Desk for Cloud and
Offered with 99.9% Cloud Availability &
Fast track cloud system implementation
with 4 system environments
Proprietary accelerators for rapid
application configuration setup
PVSentinel is pre-validated with IQ/OQ
and is UAT ready
Is your organization looking out for a comprehensive PV operations management system?
Are you looking out for an intelligent solution which can readily integrate and optimize your Pharmacovigilance vendor oversight processes and get you proactively ready for audits and inspections?
Feel free to contact our team with your challenges and let us present the optimal solution to you.