Clinical Trials 5.0

Making clinical trials highly-efficient and sustainable




Clinical Trials 5.0

Making clinical trials highly-efficient and sustainable


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.

Assures the achievement of higher quality standards and prevent any risk that could potentially harm study results and data

Introduces the next generation data management & analytics to allow for quick results and decisions in case of adaptive design and

interim analyses

Allows the collection and real-time analysis of remote patient’s parameters measured in the real world condition

Guides any operational action through the support of data analytics and predictive models

Provides patients the opportunity of an active and remote engagement to study participation overcoming geographical obstacles and retention risks

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.


Advances Analytics & Insights


Clinical Trial Management System


Electronic Trial Master File


Electronic Informed Consent



Genius eCEA™

Electronic Clinical Endpoint Adjudication


Trial Supply Management


Quality Risk Monitoring & Management


Treatment Allocation


Safety Report & Management


Electronic Source Data

Genius eQUAM™

Quality Management

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