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)
“This new process of obtaining the patient’s consent to participate to a clinical trial has clear advantages over the conventional way. Now we have a multi media-based informed consent process with real-time tracking options, which provide more consistent and better understanding to study subjects," said Luigi Visani MD, President & CEO of Exom Group.
“Not only can we now document the information provided to subjects, but also their resultant understanding. There is one standardized process with a predefined standard across sites, which allows for real-time remote monitoring and audit access. This minimizes legal exposure, reduces potential regulatory findings. Ultimately it will enable remote study models, such as patient-centric or site-less clinical trials and potentially set new quality standards."
Additional Information
For more on Exom Group: info@exomgroup.comAbout Exom Group
Exom Group is “The Human Digital CRO” that provides cloud technological solutions & value-added services for clinical development of drugs & medical devices. We combine the strong medical, regulatory and operational expertise of our staff, with the most disruptive digital cloud technological solutions to reduce costs and increase quality and performance of Clinical Trials. Exom Group is headquartered in Milan, Italy and operates in both Europe and the USA. For more information visit www.exomgroup.com
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Landmark Phase III Trial Shows Keytruda Significantly Improves Event-Free Survival in LA-HNSCC
April 28th 2025Interim KEYNOTE-689 trial data show that perioperative Keytruda significantly lowers the risk of disease progression or recurrence in resectable, locally advanced head and neck squamous cell carcinoma, marking the first major clinical advance for this patient population in more than two decades.
