
and clinical trials can account for up to two-thirds of the total research & development costs. The traditional clinical trial process that was designed for mass-marketed blockbuster drugs no longer meets the emergent needs of life science companies. In today’s fast-paced, highly complex clinical trial environment, where companies have shifted to more targeted therapeutics and precision medicine, which are focused on smaller, geographically distributed patient segments, the aid of innovative, digital technologies is becoming more and more critical. Having the right insights at the right time to make analysis-ready data available faster than ever is the center piece of modern Clinical Trials – or as we call it Clinical Trials 5.0.
With Clinical Trials 5.0 we put the human back in the center of clinical studies. The team gets real-time data from a variety of stakeholders, such as monitors, investigators, and patients, and can utilize advanced analytics for ongoing, actionable insights throughout the entire trial execution. Using dashboards to visualize on-demand subject, site, and monitor performance data, the study manager keeps any study metric under control by prioritizing the right actions at the right time.
Exom‘s clinical trial 5.0 ecosystem, Genius Suite, is HIPAA and GDPR compliant, and offers capabilities that can help life science organizations accelerate trial timelines, optimize processes, and reduce overall trial costs.
The ‘Clinical Trials 5.0’ program at Exom Group, the Human & Digital CRO, is geared towards simplifying the lifes of study stakeholders by supporting them with innovative technologies. With Clinical Trials 5.0 Exom helps sponsors and study staff to manage trials in a cost-optimized and reliable way, and advanced analytics with data from disparate sources utilizing artificial intelligence (AI) and machine learning (ML) to advance clinical trials more efficiently. For patients Clinical Trials 5.0 offers more flexibility in study participation by e.g. participating in virtual clinical trials, and a higher adherance and retention by better patient education using electronic Informed Consents.
When managing clinical trials, Exom utilizes the power of its proprietary Genius SUITE™, a fully-integrated clinical trial management suite, consisting of all tools to efficiently plan, manage and evaluate clinical trials.

GENIUS eFeasibility™
Electronic Study Feasibility
GENIUS eCRF™
Electronic Data Capture
GENIUS IWRS™
Treatment Allocation
GENIUS eSource DDC™
Direct Data Capture
GENIUS ROSA™
Telemonitoring
GENIUS eTMF™
Electronic Trial Master File
GENIUS ENGAGE™
Electronic Informed Consent
GENIUS VIGILANCE™
Safety Report & Management
Genius ePRO™
Electronic Patient Reported Outcome
GENIUS WIZARDS™
Advanced Analytics & Insights
GENIUS eDSM™
Trial Supply Management
Genius eCEA™
Electronic Clinical Endpoint Adjudication
GENIUS EVA™
Virtual Investigator Assistant
Genius AGENDA™
Patient’s Visit Calendar
GENIUS CTMS™
Clinical Trial Management System
GENIUS RIBAM™
Risk-based Monitoring
Genius eQUAM™
Quality Management
GENIUS DaMA™
Next Generation Data Management & Advanced Analytics
GENIUS eDocumentum™
Long-Term Document Archving
GENIUS SiteVAULT™
Site Document Storage