Janssen is striving to develop and implement new approaches to improve the clinical trial process for all stakeholders: patients, trial sites/investigators and the healthcare industry at large.

Janssen Clinical Innovation (JCI) is a dedicated global team leading these efforts, in partnership with all pharmaceutical R&D functions. We work to create, scale and embed new operational approaches and technologies into Janssen’s R&D engine with the goals of improving patient engagement and site satisfaction, expediting drug development and reducing costs.

We are committed to open innovation, looking beyond our own walls for both inspiration and sharing solutions we develop with and for the industry.

Our Focus Areas

Our strategic focus areas include digital health, non-conventional trial models, patient and investigator centricity, biotech-like early development, and infrastructure projects to leverage real-world patient data for research.

Key programs developed under JCI’s leadership are:

iSTEP
iSTEP (Integrated Smart Trial & Engagement Platform) a first-of-its-kind information technology platform that seeks to provide personalized and real-time patient support and automate patient data and clinical supply management throughout the entirety of a trial. The initial scope, known as eMeds, consists of 3 features - Site Kit Tracking, Patient App and Smart Blisters – and is built up in a flexible way allowing for customized implementation based on study needs. The full scope of iSTEP is being developed to have expanded clinical and commercial functionalities, such as eConsent, smart devices/biometric monitoring and additional patient engagement tools.

eConsent
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, Inc. 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 online tool was 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/Global Trial Community
This program is being developed to provide patients with convenient, on-demand access to select data collected during clinical trial visits. Patients in trials that are part of the pilot program are able to view and download certain clinical trial data and share it with others, such as their primary care physician, through a secure portal. The Patient Data Access initiative is part of a larger program, Global Trial Community, the vision of which is to create better patient engagement throughout a clinical trial; and, after the conclusion of the trial, create an opportunity for patients to stay connected with the sponsor and investigator as well as with other trial participants.

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

Patient Data for Research
The need to generate evidence in the real world, based on data derived in the clinical setting outside of the randomized clinical trial, is growing rapidly. Through extensive external collaborations, including the EU Innovative Medicines Initiative (IMI) programs, we develop infrastructure and incorporate diverse capabilities and skillsets to interact with and analyze real world data (RWD) to generate real world evidence (RWE). The introduction of RWD/EHR (Electronic Health Records) platforms could facilitate optimization of clinical research and stimulate strategic collaborations to advance medical science overall.

Industry Collaborations & Leadership

True to our mission to transform clinical trials on a broad basis, Janssen collaborates globally 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. This approach was adopted by TransCelerate BioPharma Inc. with the tool named Investigator Registry, to enable participating biopharmaceutical companies to share investigator data with each other once consent from the site is obtained.