Decentralized clinical trials
in Europe

Un homme et une femme réalisant un test clinique à domicile

A global solution for your decentralized clinical trials in Europe

• A user-friendly communication and data collection platform
• A management and coordination team and a team of healthcare professionals deployed in participants' homes

A social purpose corporation

CosyTrials is a company with a mission, whose “raison d'être” (purpose) is the permanent respect of national and international ethical principles for the protection of individuals and the development of the well-being of research participants.
CosyTrials contributes to accelerating access to innovations that respect societal and environmental issues.

Un médecin et son patient dans le cadre d'une recherche clinique à domicile
Photo de médecin avec liste des avantages pour un médecin investigateur à réaliser une recherche clinique décentralisée
CosyTrials Logo - recherches cliniques Ă  domicile

CosyTrials is a global solution that enables all types of research to be decentralized : drugs, medical devices, cosmetics, food supplements...

CosyTrials combines an innovative business software with a team of research professionals deployed on the field.

In particular, CosyTrials makes it possible to broaden the geographical and medical scope of participant recruitment: new profiles, people far from hospitals, pathologies in ambulatory medicine.

The CosyTrials platform ensures communication between research teams and participants.It generates real-time follow-up charts and operational dashboards for investigators and sponsors.

CosyTrials is in continuous co-development with investigators, with the aim of facilitating and accelerating the work of research team members.

A platform designed by investigators

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A single folder for all research documents

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Appointment management

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Follow-up of research actions

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Real-time collaboration with the in-house pharmacy

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Televisits, E-consent, questionnaires, secure messaging, etc.

Capture d'écran du logiciel permettant de réaliser des études cliniques décentralisées

Designed for participants

Conviviality

• Simple, ergonomic design, specifically formatted for each trials
• Participant calendar, reminders, notifications and specific instructions for each visit
• Creation of text, audio and video supports to explain the trial
• Facilitates volunteer participation and maintains their interest in research

Security

• Health Data Host located in the EU
• Encryption of data flows
• Role-based authorizations for enhanced security
• Traceability of actions

A personalized support depending on your needs

By clinical research engineers and nurses

• Assessment of research feasibility at each participant's home
• Assisting participants in using the platform
• Carrying out research procedures in compliance with the national rules of their profession
• Delivery and management of equipment at the participant’s home
• Management of treatment compliance

Une infirmière et sa patiente dans le cadre d'un test clinique à domicile

Successfully decentralize in Europe !

How can we decentralize our clinical trials in France with CosyTrials ?

CosyTrial is involved in designing the decentralization of your research projects with the various stakeholders, so as to create a simple, controllable, secure and efficient organization.

Can we use our own participant surveys on the platform ?

Our platform allows you to directly implement your surveys, whether it is via a link to your software or by integrating your solution in CosyTrials’ platform.We can also recreate your surveys directly on our platform.

How will participants be informed ?

In addition to the information required to obtain informed consent, which is provided by the investigator or a person delegated by the investigator. CosyTrials has a creative team that develops general information materials on clinical research, practical information on how to use the platform and how to organize home research, including what they need to do themselves. Depending on the participant's choice, information can also be delivered by professionals at home or by videoconference. Throughout the research process, participants can ask questions to either the investigator or his team, or the nurses who visit them at their home. We can integrate the sponsor's text or video instructions into our platform.

How do you organize the coordination of a decentralized clinical trial ?

CosyTrials appoints a team coordinator for each trial. The coordinator ensures that procedures are followed by the whole team, that communication takes place between all team members and that research progress is monitored. In the case of hybrid research involving both an investigation center and at home study, an organization plan is drawn up specifically for each study. The plan describes everyone's roles and the flow of information between teams. CosyTrials ensures that the additional workload for investigators induced by decentralization is drastically reduced.  The platform enables permanent communication between the teams, so that everyone can monitor the progress of the research.

Have you developed services for participants after the end of the clinical trial ?

CosyTrials offers sponsors and investigators to keep participants' contact information after the end of the research, in compliance with the RGPD and the French Data Protection Act n°78-17, in order to disseminate information to them on the progress of the trial and when they are available on its result.

Are you involved in the regulatory aspects ?

CosyTrials drafts the entire section relating to its decentralization activities, with a view to submitting the file to the competent authorities, the ethics committees.

Contact us

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Deux personnes face Ă  un ordinateur