Exom Launches First Electronic Informed Consent-eTMF Combo
Milan, Italy – Exom Group, the Human Digital CRO, has launched Genius ENGAGE™, the industry’s first ever electronic Informed Consent solution whose digital workflow is fully combined with the eTMF, and integrated with the eCRF, admitting data entry only after the patient has digitally signed the consent form.
Genius ENGAGE™ allows for a multi-media Informed Consent process on a flexible computer tablet based platform, which is compliant with all legal and regulatory requirements.
The digital backbone of the electronic Informed Consent, is Genius SUITE®, the first multitenant cloud and mobile application that unifies information, documentation, data and processes globally for a single sign-on access and source of truth across any clinical trial.
Genius SUITE®, is the first and only suite of clinical applications that combines in one study portal the following functionalities, to accelerate trial execution andgain real-time visibility into any trial related operations:
- Electronic Informed Consent (ENGAGE)
- Randomization to treatment (IWRS)
- Drug Supply Management (DSM)
- Patient’s Recruitment (eENROLL)
- Source Data (eSOURCE)
- Project Management (CTMS)
- Trial Master File & Site File (eTMF/eISF)
- Mobile Data Collection (upCRF)
- Risk-Based Monitoring (RIBAM)
- Real-time Study Metrics (INSIGHT)
- Patient’s Visits Calendar (AGENDA)
- Patient’s Reported Outcome & Diary (ePRO)
- Safety Report & Management (eSAE)
- Electronic Central Event Assessment (eCEC)
- Certified Trainings (eDOCEBO)
- Quality Management (eQUAM)