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.
Understanding the RTF Letter
Understand what the refusal-to-file (RTF) process is and what the Food & Drug Administration (FDA) is looking for.
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.
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.
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.
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.
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.
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.
sIRB Review for Multicenter Research: A Guide for Institutions
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 ...
The Critical Role Sites Play in the Evolution of Clinical Trials
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 ...
Clinical Research in the COVID-19 Era: Methods for Continuity
The COVID-19 pandemic has led to a significant shift in day-to-day research operations. To keep research moving forward, sponsors need to build a solid foundation to support the virtualization of ...
Informed Consent: 6 Approaches to Increase Participant Comprehension
Ensuring participants have appropriate knowledge of a study is a crucial goal of the informed consent process. This paper describes six research-based approaches for improving informed consent and supporting participants’ ...
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