Challenges: Redefining Certificate Management for Global Clinical Trials
Managing insurance certificates for a global biopharmaceutical captive is a complex process, particularly in the realm of Clinical Trials Liability.
Each certificate must align with the regulatory requirements of specific countries, the nuances of individual trials, and the many parties involved.
Until recently, captive owners faced a lack of efficient, automated tools for this task due to the diversity of global regulations, the inflexibility of off-the-shelf solutions, and the challenge of providing secure access to both internal and external users.
Solution: A Unified Platform Tailored for Complexity
We have a long-term track record of delivering complex IT solutions to the insurance industry. Partnering with the client, Intersys set out to build a certificate management system that addressed these pain points head-on.
Developed using advanced Microsoft technologies and informed by years of collective industry experience, the platform was designed as a web-based, one-stop shop for all certificate management needs. It offers issuance of tailored certificates, configurable workflows to accommodate global insurance programmes, secure storage, and a central repository for the captive to monitor risk and exposure.
The system delivers a user-friendly experience for both administrators and requesters, with step-by-step interfaces and instant feedback on request status.
A rapid prototyping methodology ensured end users — including Clinical Trial Leads, CROs, and insurance partners — could provide feedback early and often. This collaborative approach, combined with seamless integration of historical data, enabled a smooth go-live and eliminated the need for parallel legacy processes.
The initial roll-out was ambitious, onboarding over 150 external users alongside internal teams, yet the extensive socialisation and intuitive interface ensured swift adoption.
Implementation: Meeting Global Demands with Flexibility and Security
The system’s design enables tailored certificate request forms that meet the information requirements of each country, insurer, or regulator.
Workflows are optimised for the unique challenges of Clinical Trial certificates, including automatic issuance using insurer templates and secure storage of original and amended documents.
The platform offers real-time performance tracking, PowerBI-enabled reporting, and comprehensive action monitoring.
Secure access is ensured via Single Sign-On for the client’s 80,000+ employees and MFA for key external partners, supporting collaboration with CROs, underwriters, and brokers.
Results: Exceeding Expectations in Efficiency and Compliance
Within just six months of full-scale deployment since February 2025, the platform has issued over 1,600 Clinical Trials Certificates, managed nearly 4,000 historic requests, and sent upwards of 14,000 email notifications. The anticipated benefits have not only been realised but exceeded, including:
- Accelerated turnaround for manual certificates
- Enhanced visibility and control across all certificate requests
- Increased user compliance through structured information capture
- Robust KPI tracking and performance monitoring
- Flexible configuration for future lines of business
- Secure, centralised access for both internal and external parties
Conclusion: Setting a New Standard for Insurance Certificate Management
By automating and streamlining one of the industry’s most challenging classes of business, the partnership between Intersys and our client has set a new benchmark for efficiency, visibility, and compliance in global insurance certificate management.
This scalable platform is poised to support additional lines of risk, ensuring continued innovation and risk mitigation for global captives well into the future.
