genae
Untangling the Complexities of Clinical Trials

Medical device and diagnostic companies are conducting more clinical trials than ever, as more than 500,000 types of devices are produced globally each in service to a variety of health objectives. Clinical trials that encompass thousands of patients generate large amounts of data—from the processes that span across enrollment to site-activation and monitoring. On a simple yet powerful mission to combine these massive amounts of clinical data with technological expertise to deliver the best results at the end of the trial period is genae. With over 15 years of experience and 450 device trials in various therapeutic areas, this clinical research organization has created a quality management system that is curated and designed for medical and combination devices. “The co-founders identified an unmet need for excellence in medical device clinical trials, which was the driving point to the inception of genae,” says Philippe Kassab, president of genae Americas.

After building a strong footprint in Europe, seven years ago, the company spearheaded an expansion into the U.S. market to help its clients transition smoothly into the FDA clinical trials. With unequivocal expertise in the technology and infrastructure required to standardize and harmonize their work across both the geographies, genae focuses on developing the full approach to handle every intricacy involved in the trial phase. In 2014, genae acquired e-novex, a leading provider of electronic data tools, and expanded the expertise for safety, data, and regulatory management in-house, which enabled them to deliver second-to-none solutions tailored to their client’s requirements.

genae’s global CRO offerings stand on three major pillars that uphold the safety and ethics involved in medical device clinical trials while improving the standards of care across the healthcare industry.

Combining genae’s clinical expertise in medical devices with strong digital health and analytics will allow for accelerated and efficient outcomes

The first part entails clinical trial and site management, and onsite or remote monitoring. The second is regulatory and safety, which are critical components to a successful study, and genae ensures this by timely regulatory submissions as well as the ongoing clinical safety reporting as per the regulatory requirements. The third component is the digital health unit that provides a data collection platform for an organization who can garner real-time insights through the meaningful data delivered.

Last year, genae launched a digital health data management platform called staicy that not only captures data but adds layers of powerful analytics and AI technologies to handle clinical trial data in the most effective cloud-based manner. Additionally, the product meets all the regulatory requirements from HIPAA compliance to 21CFR Part 11, ensuring its critical role in the success of clinical trials.

genae strives to position itself as an extension of their client’s clinical department, irrespective of their size or the type of work at hand. Their approach paves the way for a clear understanding of the unique requirements of their clients, enabling them to customize their solutions to create a flexible clinical trial pathway accordingly. “Clinical research is a very people-focused business, and our services provide the flexibility and adaptability our clients require to deliver the support our customers need,” says Kassab.

At the beginning of this year, the company announced the acquisition of HPX, which is a robust analytics platform that will foster genae’s data-driven approach and enhance their clients’ deliverables when it comes to clinical pathways. They plan on adding more refinements to their flagship product, staicy, which will result in the complete digital transformation of medical device clinical trial processes. “We will continue focusing on the development of clinical trials and footprint expansions in the U.S. market,” concludes Kassab.