White Paper
4 Modernized Functions Every Sponsor Needs for Study Startup
This white paper outlines four technology capabilities sponsors need to expedite the study startup process.
Navigating Key Complexities in the Development of Cell and Gene Therapies
Explore the uniquely complex regulatory guidelines and challenges cell and gene therapy presents in research.
Data on the go: Mobile Application Considerations for Clinical Trials and Beyond
Find out the necessary regulatory and ethical considerations when utilizing an app or connected device in human subjects research.
Unique First-in-Human Phase I IRB Considerations you Might not Know About
An institutional review board (IRB) may ask some different questions for first-in-human (FIH) Phase I trials than later phase studies.
Understanding how to Build and Leverage a DSMB Statistical Plan
Find out about the DSMB statistician’s roles, how study design can impact DSMB analysis, and what goes into a DSMB statistical plan.
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