IVIDATA Life Sciences supports the digitalization of clinical trials for a large pharmaceutical company

In November 2021, a major pharmaceutical company launched a project to decentralise clinical trials in order to collect adverse reactions to vaccines via a mobile application. The aim of this major project is to facilitate the work of investigating centres, enable participants to enter data directly into the application, optimise costs and timescales, and improve the quality of the data collected. The pilot phase involved 6 studies with between 560 and 1,400 patients.

One of our IVIDATA Life Sciences consultants joined the project as Project Manager. Surrounded by a heterogeneous team made up of Clinical Data Leads, Clinical Study Managers, translators, clinicians, logisticians, and a project manager, he has been working with the company to ensure the success of this new application.

As part of its vaccine-related activities, the pharmaceutical company was testing an application to facilitate the collection, real-time transfer, and analysis of safety data from participants in pilot studies. For example, if a serious adverse event occurs in a participant, the study sponsor is immediately informed, and sets up the procedure to be followed.

Wherever digitisation is involved, there is a need to standardise information. This makes it possible to facilitate the configuration that must ‘fit’ with the design of the study and the data that needs to be collected. This is one of the major challenges of digitisation, as it will significantly speed up the upstream preparation stages, improve the quality of the data collected and its analysis, and optimise costs.

Standardisation will also help to reduce the stress associated with the preparation of studies, which require a great deal of coordination and cohesion from all the parties involved over several months.

The initiative also has numerous benefits for study participants. They can enter their data from anywhere: at home, on the train, in the supermarket, etc. Thanks to this new application, study participants no longer have to travel to study centres. The data is sent directly to the investigating centres and the sponsor. The application also has a notification system to remind participants not to forget to enter their information at the time defined in the protocol.

The first step in setting up this application was to ensure that it complied with GDPR requirements, and in particular with Title 21 CFR Part 11, promulgated by the Food & Drug Administration (FDA). Between April and November 2022, the team worked with our customer to ensure that the design and functionality also met the company’s standards.

The next step was to implement the change management plan, which was key to ensuring that the application was properly adopted by the various stakeholders. To do so, it was essential to provide the necessary documentation to make it easier to learn and use the application, regardless of the country.

Six studies were then included in the pilot phase, analysing data from 560 to 1,400 participants. The challenge was considerable, since in all the pilots it was necessary to manage the mix of data collected via the application and that collected in paper format on an ad hoc basis for participants who had not been able to use the application.

100% of the participants included in the pilot phase have now been enrolled in the application, and the industrialisation phase has been underway since April so that the application can be used in all future studies.

To ensure the success of such a project, 4 points are essential:

• Change management: It is essential to ensure that everyone is properly trained. To help people get to grips with the system, it is vital to provide short, precise, practical documentation tailored to each type of user. These may be patients, doctors involved in the study, or the in-house clinical team. They need to be given all the keys to ensure that the application is used correctly.
• Defining roles and responsibilities: This type of project involves a large number of stakeholders, including the sponsor company, the investigating centres, and the CRA. It is essential to clarify the roles and responsibilities of each party involved in configuring and using the application. The Clinical Study Manager and Clinical Data Lead have particularly important roles, and the application cannot function without the support of these 2 complementary areas of expertise. It is all the more important that they know exactly what their roles and responsibilities are, and that they can act as real facilitators.
• Access management: This seems obvious, but it is necessary to ensure that everyone involved has the right access to the clinical data management system.
• Setting up effective international support: Once the study has been launched, access to responsive support is essential.