Expanded Access to COVID Therapies in Centralized Hub

March 31, 2020

Applied Clinical Trials

Anaqua’s ideaPoint, a provider of medical affairs and innovation management solutions, has announced a strategic partnership with clinical data company WideTrial to facilitate greater access to investigational medicines for physicians and patients dealing with COVID-19 worldwide.

The project’s objective is to establish a single centralized hub through which creators of potentially effective COVID-19 therapeutics can make their products available to large numbers of people under applicable Expanded Access regulations. Expanded Access Programs (EAPs) are specially authorized clinical trials for the “treatment-use” of pre-market products by patients and their doctors who cannot participate in research trials. The new platform is designed to allow interested healthcare providers (including non-traditional trial sites, community hospitals, and clinics) to sign up online to participate in the EAPs of their choice.

Supporting the Expanded Access platform is ideaPoint, a web-based inquiry management software for life science and healthcare uses. The company has delivered physician engagement and clinical data collaboration tools in several therapeutic areas including Immuno-Inflammation, Infectious Disease, Oncology, HIV/AIDS, Respiratory, Vaccines and Rare Diseases through global EAPs for large and mid-size pharmaceutical companies. 

“With our expertise in providing software to manage and track all aspects of a global EAP and WideTrial’s clinical operations and regulatory expertise, we hope to help and support companies with potentially promising investigational medicines to fight COVID-19 and make medicines available to large portions of the global patient population as quickly as possible,” said Scott Shaunessy, Founder and CEO of ideaPoint. “We have combined forces to offer a unified resource for rapid deployment of an EAP.”

Bob Romeo, CEO of Anaqua, added, “As a global company, we deeply understand and are committed to supporting initiatives that may alleviate the effect of this pandemic worldwide. Putting people’s health first, we want to support our global pharmaceutical clients and other pharmaceutical companies in our collective efforts to urgently fight COVID-19 through supporting this modernized Expanded Access solution.”

WideTrial is a specialized clinical trial company created exclusively to sponsor large-cohort EAPs under agreements with the originating life science companies. WideTrial’s innovation includes an in-house clinical operations team, Expanded Access regulatory specialists, a unitized per-patient cost-recovery structure, and CDASH/CDISC compliant data capture tools that help streamline the workflow of busy clinicians.

Commenting on the importance of effective EAPs, Jess Rabourn, CEO of WideTrial said: “Applying traditional clinical trial business models to Expanded Access is a colossal mistake and has served only to frustrate healthcare delivery systems, drug companies, and patients. We built WideTrial to re-arrange that landscape into one that frees Expanded Access to function as it was intended, for the vast numbers of patients and doctors who cannot access a new medicine through its research trials.”