The platform provides Sponsors and CROs with the technical ability to configure each trial. They can select research sites, configure medical staff, define enrollment targets, set up the ICF, as well as a landing page and prescreening questionnaire.
A specific ICF can be set up for every trial, including new consent forms for sub-populations in case of amendments to the clinical protocol. The configuration process, through the "Trial Setting" menu, is easy and intuitive.
Trials are published on the platform, allowing patients to browse, get additional information and select the one they are interested in. Trial information can even be shared by patients or researchers through the Share button.
Patients can fill in the prescreening questionnaire at their convenience without intervention by research staff, and determine their own medical eligibility.
The prescreening questionnaire encompasses inclusion and exclusion criteria, but also dropout risk assessment questions. These help finetune the patient's profile and give indications on how to manage his/her trial journey. The goal is to improve patient retention.
Patients who have been through the eligibility process have to display some form of official identification. The platform has the built-in ability to verify that patients are who they claim to be. Thanks to the digital authentication, it is possible to electronically sign the informed consent document in a secure and compliant way.
The instant messaging app can be used between researchers and patients for urgent issues and questions. It contributes to sustained communication, a major factor for improved patient retention.
A built-in tele health visit functionality uses standard and secure protocols. The researcher can interact with a patient at any time during the conduct of the study, and enrich the patient's medical profile with useful notes.
The platform's online scheduling tool is easy to use and saves time for both researchers and patients. It is up to the researcher to decide if and when patients can book an appointment. Patients can easily visualize available slots.
Dashboards integrated into the Allyfe platform enable real time updates on enrollment metrics. Sponsors can react instantly in case of lowering performance and communicate with research sites through instant messaging.
Messaging tools can be used between sponsors, CROs and research sites to follow up on performance, to manage issues or exchange information such as protocol amendments and more. Other relevant documents can also be uploaded and sent to medical staff.
Sponsors and CROs can get a simultaneous and remote view of all the ongoing studies in their portfolio on a single dashboard. That enables them to monitor site performance, risks and progress across countries and compare site results. The dashboards are updated in real time and customized according to sponsors' needs for optimal reactivity.
All the data of the study captured via the platform can be downloaded and exported to the trial sponsor upon request. This functionality applies to individuals’ requests as well and guarantees data portability rights.
A built-in audit trail capability ensures a secure, system generated, time-stamped electronic record which allows an easy reconstruction of the chain of the events to detect security violations, performance issues and more.
All procedures, including informed consent documents, are stored electronically, which saves time and storage resources, but also prevents damaging loss of documents and data integrity breaches.