WideTrial, Inc. Company Profile

Background

Overview

WideTrial, Inc. is a clinical data company based in Silicon Valley, specializing in the sponsorship and management of Expanded Access Programs (EAPs). Founded in 2017, the company focuses on providing patients with access to investigational treatments for serious and life-threatening conditions who are ineligible for traditional clinical trials. By facilitating these programs, WideTrial aims to bridge the gap between patients and potentially life-saving therapies.

Mission and Vision

WideTrial's mission is to ensure that every patient has treatment options, not just those who meet the inclusion criteria of research studies. The company's vision is to make large-scale Expanded Access Programs feasible for all parties involved, thereby improving patient access to investigational treatments and generating valuable real-world data to inform further research and development.

Primary Area of Focus

The company's primary focus is on managing group-level EAPs, which are FDA-authorized clinical trials designed to provide pre-market access to investigational drugs for patients who cannot participate in traditional research studies. These programs are particularly crucial for patients with serious or life-threatening conditions who have no other treatment options.

Industry Significance

In the healthcare industry, EAPs play a critical role in providing patients with access to potentially life-saving treatments before they are commercially available. By specializing in the management of these programs, WideTrial contributes to the acceleration of patient access to new therapies and supports the collection of real-world data that can inform future clinical trials and regulatory decisions.

Key Strategic Focus

Core Objectives

• Patient Access: Facilitate access to investigational treatments for patients who are ineligible for traditional clinical trials.

• Data Generation: Collect real-world data through EAPs to inform further research and development.

• Operational Efficiency: Streamline the process of implementing large-scale EAPs to make them feasible for all stakeholders.

Specific Areas of Specialization

• Expanded Access Programs: Design and manage EAPs that provide pre-market access to investigational drugs.

• Regulatory Compliance: Ensure that EAPs adhere to FDA regulations and guidelines.

• Clinical Operations: Oversee the operational aspects of EAPs, including site selection, patient enrollment, and data collection.

Key Technologies Utilized

• Clinical Data Management Systems: Utilize advanced data management platforms to handle large volumes of clinical data efficiently.

• Regulatory Compliance Tools: Employ software solutions to ensure adherence to regulatory requirements.

• Patient Engagement Platforms: Implement technologies to facilitate patient enrollment and communication.

Primary Markets or Conditions Targeted

WideTrial focuses on serious and life-threatening conditions, including but not limited to:

• Amyotrophic Lateral Sclerosis (ALS): Providing access to investigational ALS treatments.

• Cancer: Facilitating access to experimental cancer therapies.

• Critical Limb Ischemia (CLI): Offering access to novel treatments for CLI patients.

Financials and Funding

Funding History

As of December 2025, WideTrial, Inc. has raised a total of $22 million in funding over one round. The latest funding round occurred on November 19, 2024, in the amount of $22 million.

Notable Investors

Specific details about individual investors are not publicly disclosed.

Intended Utilization of Capital

The capital raised is intended to support the expansion of WideTrial's EAP offerings, enhance operational capabilities, and invest in technology infrastructure to improve patient access to investigational treatments.

Pipeline Development

Key Pipeline Candidates

WideTrial collaborates with various pharmaceutical companies to sponsor EAPs for their investigational drugs. Notable collaborations include:

• Ibudilast (MN-166): An investigational drug for ALS patients ineligible for clinical trials.

• OT-101: A first-in-class RNA therapeutic targeting TGF beta for patients with advanced malignancies.

• PLX-PAD: A cell therapy product for the treatment of critical limb ischemia.

Stages of Clinical Trials or Product Development

WideTrial's role is to manage EAPs, which are typically initiated after Phase 2 clinical trials and before the completion of Phase 3 trials, providing access to investigational drugs for patients who cannot participate in traditional research studies.

Target Conditions

The EAPs managed by WideTrial target various serious and life-threatening conditions, including ALS, cancer, and CLI.

Relevant Timelines for Anticipated Milestones

Specific timelines for each EAP vary depending on the sponsor and regulatory approvals. For example, the NIH-funded EAP for ibudilast aims to enroll 200 ALS patients across multiple U.S. sites.

Technological Platform and Innovation

Proprietary Technologies

WideTrial has developed a scalable platform for managing large-cohort EAPs, which includes:

• Clinical Operations Team: An in-house team specializing in the operational aspects of EAPs.

• Regulatory Specialists: Experts in navigating the regulatory landscape for EAPs.

• Data Capture Tools: CDASH/CDISC compliant tools that streamline data collection and management.

Significant Scientific Methods

WideTrial employs standardized protocols for EAPs to ensure consistency and reliability in data collection. The company also utilizes data analytics to monitor patient outcomes and inform future research.

AI-Driven Capabilities

While specific AI-driven capabilities are not detailed, WideTrial's focus on data collection and analysis suggests potential applications of AI in monitoring patient data and optimizing program operations.

Leadership Team

Key Executive Profiles

• Jess Rabourn, CFA – CEO

Jess Rabourn has served as the CEO of WideTrial, Inc. since December 2017. He focuses on improving drug development through innovative patient engagement. Prior to joining WideTrial, Rabourn was the Managing Director at the National Board of Early Access Medicine and has experience in alternative asset management.

Leadership Changes

As of the latest available information, there have been no significant changes or appointments within the company's leadership.

Competitor Profile

Market Insights and Dynamics

The market for Expanded Access Programs is growing, driven by the increasing need for patient access to investigational treatments and the complexity of managing large-scale EAPs. Companies like WideTrial are well-positioned to meet this demand by offering specialized services that streamline the process for both patients and pharmaceutical companies.

Competitor Analysis

Key competitors in the EAP management space include:

• IQVIA: A global leader in healthcare data analytics and technology solutions.

• Parexel: A multinational contract research organization providing comprehensive drug development and regulatory consulting services.

• Advarra: A full-service, central IRB and clinical research organization.

• ERT: A global data and technology company that provides solutions for clinical trials.

• Signant Health: A provider of clinical trial technology solutions.

• Bioclinica: A global provider of clinical trial management services.

• Veeva Systems: A cloud-computing company focused on pharmaceutical and life sciences industry applications.

• Medidata Solutions: A provider of cloud-based solutions for clinical trials.

Strategic Collaborations and Partnerships

WideTrial has established several strategic partnerships to enhance its EAP offerings:

• Anaqua's ideaPoint: In March 2020, WideTrial partnered with ideaPoint to launch a global expanded access platform for COVID-19 medicines, facilitating greater access to investigational treatments during the pandemic.

• Oncotelic Inc.: In June 2019, WideTrial partnered with Oncotelic to provide OT-101 to patients who cannot participate in research trials of the investigational product.

• Mayo Clinic: In November 2024, WideTrial supported an NIH-funded expanded access program for the investigational ALS drug ibudilast, aiming to provide access to patients ineligible for clinical trials.

Operational Insights

WideTrial differentiates itself by focusing exclusively on the management of Expanded Access Programs, enabling streamlined operational processes, regulatory compliance, and data collection tailored to these specialized clinical initiatives.