White Paper

February 15, 2024

Single IRB (sIRB) review for multicenter research is fast becoming the norm in the US. Initiative such as the NIH sIRB policy and revised Common Rule make it clear that ...

Uncover how analytics, artificial intelligence, and machine learning are reshaping the foundational elements of clinical research.

This white paper walks through key GxP principles and regulatory requirements and gives a real-world case study.

This white paper outlines four technology capabilities sponsors need to expedite the study startup process.

Explore the uniquely complex regulatory guidelines and challenges cell and gene therapy presents in research.

Find out the necessary regulatory and ethical considerations when utilizing an app or connected device in human subjects research.

An institutional review board (IRB) may ask some different questions for first-in-human (FIH) Phase I trials than later phase studies.

Find out about the DSMB statistician’s roles, how study design can impact DSMB analysis, and what goes into a DSMB statistical plan.

Explore the regulatory challenges and pathway guidance for sponsors bringing innovative rare and orphan therapies to market.

This white paper discusses an endpoint adjudication committee's (EAC) role in clinical research and the basics of setting up an EAC.

This white paper shares what a data safety monitoring board's (DSMB's) role is in clinical research and how it works.

The white paper outlines key elements for clinical development organizations’ organizational redesign to improve productivity.