Insights On Clinical Technologies
-
Creating An Integrated Digital Pathway For Sites And Sponsors
8/30/2021
View this webinar to find out how the Cognizant® Shared Investigator Platform (SIP) automates the flow of documents connecting sponsor eTMF systems while enhancing site-sponsor collaboration, compounding efficiencies, and accelerating trials.
-
Unlocking New Insights By Connecting Patient-Level Clinical Data to RWD
6/20/2022
Discover data linkage: a cutting-edge innovation that unlocks a new frontier of enhanced evidence generation by linking clinical trial data and real world data at the patient level.
-
Increasing Value From Health Authority Interactions And Regulatory Intelligence - What's Next?
1/30/2023
Explore what companies are doing in the regulatory intelligence space and how they’re leveraging artificial intelligence and all the information they have from health authority interactions to optimize decision making.
-
Making Intelligent Connections Possible: Connected Devices – Better Devices
7/20/2022
The demand for connected devices in clinical trials has grown significantly, driven by a need for better, more varied data, and renewed bids to improve patient experience and reduce the burden for trial sites.
-
Automated Data Capture To Train An AI Algorithm With eSource
9/20/2022
Explore why an AI algorithm needs a steady and significant stream of data to become more accurate and prove its efficacy in a clinical setting.
-
Sanofi Builds Single Patient Data Interface
12/7/2022
Sanofi has adopted a Patient Informed Research And Development model within the organization. The goal of the model is to work with patients, patient groups, and patient communities to understand the concerns of patients and ensure those voices are heard throughout the company. The company defines this approach as engaging with patients and caregivers, hearing their concerns, and translating those insights into actions that will help develop meaningful healthcare solutions. Today, Sanofi’s development programs are 100% informed by individuals from the patient communities and 100% of Phase 2 and Phase 3 trials have a remote capability built into them.
In October 2022, Clinical Leader Chief Editor, Ed Miseta interviewed Victoria DiBiaso, global head, patient informed development & health value translation, and Terttu Haring, head, clinical innovation office at Sanofi. They discussed the new R&D model, the company’s attempts to make its trials more patient-centric, and how digital technologies and devices are helping to create a better trial experience for patients.
In this segment, Haring discusses how the use of a single patient data interface allows patients to connect with data collection systems.
-
The FDA’s Technical Rejection Criteria For Study Data: Does Your eCTD Submission Comply?
8/27/2021
To help sponsors understand how the FDA uses the eCTD technical validation rules to verify conformance, the FDA developed the technical rejection criteria (TRC) for study data. Since its inception, the FDA monitored and analyzed conformance and revised the TRC but has not implemented them until now.
-
eCOA Risk Management In The Digital Age
2/24/2022
Regulators across the globe are urging the industry to strengthen their data integrity practices. This article addresses the additional considerations that go hand in hand with the increased reliance on eSource data and the expansion of the electronic systems in clinical trials.
-
Agile eConsent: Taking A Flexible Approach To Global Implementation
6/28/2022
Hear from industry experts on how they successfully combined agile eConsent technology with global regulatory expertise to increase enrollment rates and reduce both site and patient burden.
-
Why Sanofi Became A Patient-Centered R&D Organization
12/7/2022
Sanofi has adopted a Patient Informed Research And Development model within the organization. The goal of the model is to work with patients, patient groups, and patient communities to understand the concerns of patients and ensure those voices are heard throughout the company. The company defines this approach as engaging with patients and caregivers, hearing their concerns, and translating those insights into actions that will help develop meaningful healthcare solutions. Today, Sanofi’s development programs are 100% informed by individuals from the patient communities and 100% of Phase 2 and Phase 3 trials have a remote capability built into them.
In October 2022, Clinical Leader Chief Editor, Ed Miseta interviewed Victoria DiBiaso, global head, patient informed development & health value translation, and Terttu Haring, head, clinical innovation office at Sanofi. They discussed the new R&D model, the company’s attempts to make its trials more patient-centric, and how digital technologies and devices are helping to create a better trial experience for patients.
In this segment, DiBiaso discusses the thinking behind the creation of a patient-centered R&D organization.