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White Paper

Ethical Issues in the Design and Review of Decentralized Research

This white paper aims to provide a framework to understand ethical issues and steps to take in deploying a decentralized trial

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White Paper

Steps to Implementing a Quality Management System

This white paper outlines the full implementation process of a quality management system and how to avoid conflict by focusing on quality.

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White Paper

End-to-End Approach to Clinical Development

Download our white paper for practical strategies for enhancing innovation, efficiency, and talent development in clinical research.

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White Paper

Understanding the RTF Letter

Understand what the refusal-to-file (RTF) process is and what the Food & Drug Administration (FDA) is looking for.

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White Paper

Understanding the Current and Future States of Cell and Gene Therapy Research

This white paper focuses on gene therapy uses in oncology and looks at a successful program at an NCI-designated comprehensive cancer center.

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White Paper

Vendor Management and Oversight of Clinical Trials

This white paper provides practical insights and guidance on the key concepts that will help any sponsor better manage their clinical trials.

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White Paper

Site Technology Guide for Facilitating GCP in Decentralized Trials

Download the white paper to learn how to adhere to Good Clinical Practices (GCP) while managing the entire decentralized trial process.

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White Paper

Developing a Data Strategy for Clinical Trials

This white paper outlines a standardized method to creating a data strategy specific to an organization’s unique needs.

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White Paper

Improving Access to Research for Diverse and Underserved Populations

Increasing diversity and inclusion in research has long been a challenge in the clinical research community. Learn strategies to increase access to clinical trials for all.

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White Paper

Case Studies in Accrual Prediction

Accrual is the ultimate outcome of success for a clinical trial. Reports estimate that at the site-level 30%-50% of studies close with zero-accrual.

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White Paper

sIRB Review for Multicenter Research: A Guide for Institutions

January 27, 2021

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 ...

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White Paper

The Critical Role Sites Play in the Evolution of Clinical Trials

October 26, 2020

Drawing on the perspectives of experts from Parexel and Advarra, this white paper explores the evolving role of technology in clinical research and its impact on research sites and study ...

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