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Ventiv’s risk management technology has enabled Takeda Pharmaceutical Company to create a first-of-its-kind platform to issue insurance certificates for clinical trials. With automation, the system significantly speeds up the process of issuing certificates, freeing up valuable resources and greatly improving the end-user experience

Critical function

Clinical trials are at the heart of the discovery and development of new medical treatments, creating a pathway to test the safety and efficacy of new therapies while also providing an engine of growth for the pharmaceutical industry. However, clinical trials are closely regulated, with strict rules for authorization, liability, and insurance.

Evidence of insurance is of paramount importance when applying for clinical trial approval, and it is even more so under the new EU Clinical Trials Regulation, which requires approval within 60 days. The timely and accurate provision of certificates of insurance is therefore critical to a highly innovative life sciences company like Takeda Pharmaceuticals, which currently has over 350 active clinical trials running in 71 countries.

In early 2019, Takeda’s Global Insurance and Risk Management function, based in Paddington, London recognised an opportunity to speed up and improve the process for issuing insurance certificates. Within just three months, Ventiv and Takeda had developed and deployed a new system to streamline and accelerate the issuance of certificates of insurance for clinical trials, with a best-in-class experience for end users, Takeda’s research associates, and contract research organizations.


Best-in-class solution

The task of issuing an insurance certificate is far from straightforward, requiring data to be exchanged between various parties, including Takeda’s captive insurance company; its insurance partner, HDI Global SE; and its broker, Aon Life Sciences. Regulation is another critical factor. Given the international nature of clinical trials, certificates must be compliant with each jurisdiction’s insurance and authorization requirements.

Takeda’s new insurance certificate system combines Ventiv risk management software with Takeda’s best-in-class practices. It builds on an existing Ventiv platform developed for Shire, a global life sciences company that was acquired by Takeda in January 2019. The project involved the migration of Takeda’s clinical trial and insurance data over to the Shire system (both companies use Ventiv RiskConsole). Ventiv then worked with Takeda’s insurance and risk management team to further enhance and automate the process.

The new certificate system manages the entire process, connecting the various parties and automatically creating compliant certificates across multiple jurisdictions. To that end, Ventiv worked closely with HDI’s global network to upload a new set of country-specific certificate templates, many with electronic signatures.

Simple and intuitive

While Ventiv technology seamlessly takes care of the complex process of creating certificates in the background, the front-end portal ensures the experience for all users is quick and easy. By incorporating Ventiv’s risk management tool, the new system automatically collates the information required from various parties to generate the certificate and uses a simplified and intuitive interface to guide users through the process.

The system employs an advanced repository system, so users are not required to upload documents or log into the system after the initial sign-on. As the system automatically saves all documents and correspondence, it removes the need for manual document saving and review, and it also provides an audit trail and the ability to generate management reports.

The certificate system was designed to be flexible and adaptable. In one recent clinical trial, for example, confidentiality was essential, and access to data was restricted within the system. The solution is capable of issuing insurance certificates from historical trials underwritten by previous insurers, and it has been developed to be future proof. Built on the foundation of Ventiv’s risk management solution, the certificate system can easily be upgraded and further enhanced to include powerful Ventiv technology as it becomes available.


Stepping stone

The Takeda certificate solution is among the most advanced of its kind. In what is believed to be the first such system in the pharmaceutical industry, the solution enables the production of instantaneous insurance certificates on a huge scale and in multiple countries. This is a major evolution from the typical manual certificate process and represents significant time and cost savings.

The solution, delivered against a challenging deadline, has significantly reduced the time and complexity of insurance certificate issuance for Takeda, as well as extending the automatic issuance of certificates in an additional 19 countries. Takeda now generates some 80% of its global certificates using the new platform, which can process certificates in triple the number of countries a typical captive would be able to handle. This positions Takeda ahead of the curve in terms of meeting regulatory compliance under EU Clinical Trials Regulation.

The issuance of insurance certificates is only one area of insurance ripe for automation. The technology behind Takeda’s insurance certificate system can be applied to a wide range of tasks and processes related to insurance policy documents and claims. Platforms like the one developed by Ventiv with Takeda demonstrate how technology can remove manual processing, reduce costs, and improve overall service levels for the end users.