Operationalizing Research Analytics: Today, Tomorrow, Someday
Uncover how analytics, artificial intelligence, and machine learning are reshaping the foundational elements of clinical research.
GxP Compliance in Clinical Research
This white paper walks through key GxP principles and regulatory requirements and gives a real-world case study.
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.