Rare and Orphan Diseases: Choosing a Path to Regulatory Approval and Market Success
Explore the regulatory challenges and pathway guidance for sponsors bringing innovative rare and orphan therapies to market.
What Does an Endpoint Adjudication Committee (EAC) Do?
This white paper discusses an endpoint adjudication committee's (EAC) role in clinical research and the basics of setting up an EAC.
Establishing and Operating a DSMB: Tips for Clinical Trial Success
This white paper shares what a data safety monitoring board's (DSMB's) role is in clinical research and how it works.
Planning Organizational Design for Clinical Development Organizations (CDOs)
The white paper outlines key elements for clinical development organizations’ organizational redesign to improve productivity.
Expedite Study Startup: Four Strategies to Optimize Site Activation
Learn how organizations can expedite study startup by streamlining site selection, training, ethics review, and site initiation.
The Rise of the Clinical Research Network: Using Technology to Connect Sites and Sponsors
An integrated approach to the clinical research industry’s technology landscape can improve access and diversity, save time, and better serve patients
Planned Emergency Research and Exception from Informed Consent
This white paper outlines considerations for those involved in planning, designing, conducting or reviewing EFIC studies
Ensuring Success with Clinical Development Planning
This white paper describes how to ensure a clinical plan’s feasibility, focusing on issues that matter, and mitigates anticipated program risk.
Executing a Successful Clinical Strategy
A clinical development plan is designed to bring an investigational medicinal product to market through outlining risks and opportunities to a program.
Reporting to the IRB: What Does and Does Not Need to be Reported
This white paper outlines IRB reporting requirements, why reporting is important, and what should and should not be reported.
The ROI of Site-Centric Training and Support
Download our white paper to learn how to maximize your research investment for site-centric training and support.
Enabling Compliant Remote Data Capture and Document Management
Download this white paper to learn how to establish consistent electronic processes to help manage clinical trials remotely.