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Clinical Trials

R&D Operations Innovation

At Janssen, a key goal is developing and implementing new approaches to make the clinical trial process better and faster for all stakeholders: patients, trial sites/investigators and the healthcare industry at large.

Janssen Research & Development Operations Innovation is a specialized global team leading these efforts, in partnership with drug development teams across Janssen. We work to identify, develop and test new operational models, technologies and solutions for clinical research, as well as to support Janssen’s vision of “A World Without Disease.

Our team then works to facilitate broad implementation of successful solutions throughout the Janssen organization. We are also committed to open innovation, looking beyond our own walls for inspiration and sharing solutions we developed with the industry.

Our Programs

Current innovation strategy focuses on better integrating clinical trials into patients’ lives, where applicable, as well as creating new operations models to drive efficiencies and enable new scientific objectives. Ongoing programs encompass digital health tools, novel trial concepts, new data sources and patient-centric clinical trial initiatives.

iSTEP (Integrated Smart Trial & Engagement Platform) seeks to transform clinical trial medication and data management while engaging the patient throughout the entirety of the trial. The technology platform, currently in development, is designed to be capable of supporting registrational clinical trials. The initial scope, known as eMeds, leverages mobility, smart packaging and electronic drug labels in an effort to streamline and automate the clinical supply and data management process. The full iSTEP platform is planned to add inter-linked functionalities including eConsent, smart devices/biometric monitoring and patient engagement tools.

The tablet-based electronic informed consent program is designed to provide an interactive, educational experience for prospective clinical trial participants. eConsent’s multimedia features are intended to help patients understand trial requirements, risks and patient rights. Janssen pioneered implementation of eConsent in multi-country/multi-language trials and is a key contributor to the TransCelerate BioPharma eConsent initiative.

Janssen Global Trial Finder
Janssen Global Trial Finder was designed to help individuals easily access information on Janssen clinical trials around the world. The interface is created to make it easy to search for Janssen clinical trials that are currently accepting new participants. People interested in enrolling in a clinical study can use the Janssen Global Trial Finder to search for Janssen clinical trials by medical condition and geographic location.

Patient Data Access
This initiative is to explore providing patients with convenient, on-demand access to routine lab data collected during clinical trial visits. The concept is that patients would be able to view and download their data and share it with others, such as their primary care provider, through a secure portal. Janssen believes that this may improve patient engagement in the clinical trial process. Janssen is continuing to evaluate whether and in what manner patient access to clinical trial data would be appropriate.

Patient Voice in Trial Design
By including patients’ input during the early stages of clinical trial development, Janssen is exploring new ways to proactively address potential enrollment and retention challenges. Janssen has collected the “patient voice” through a variety of means, including social listening, patient interviews, surveys and simulated trials.

Industry Collaborations & Leadership

In carrying out our mission to transform clinical trials, Janssen collaborates with leading healthcare organizations, technology partners and pharmaceutical companies. We also provide leadership to industry organizations that share in our vision for clinical trial innovation.

Janssen led the formation of the Investigator Databank, a cross-industry collaboration with the goal to reduce the administrative burden for investigators and increase the visibility of qualified investigators to research sponsors. We also are a founding member of TransCelerate BioPharma, a non-profit organization with the vision of simplifying and accelerating the research and development of innovative new therapies, and contribute to other key industry programs.

For more information about ongoing initiatives or potential collaborations, contact [email protected].

Clinical Trials

Clinical Trials

Donna Williams, Discovery
Donna Williams, Discovery