White Paper

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.

Learn how organizations can expedite study startup by streamlining site selection, training, ethics review, and site initiation.

An integrated approach to the clinical research industry’s technology landscape can improve access and diversity, save time, and better serve patients

This white paper outlines considerations for those involved in planning, designing, conducting or reviewing EFIC studies