Trend Report: 2023 Trends Impacting Clinical Research
This report defines 2023 clinical research trends and provides an outlook for the industry moving forward.
Privacy Regulations Impact on Global Clinical Trial Endpoint Adjudication
Endpoint adjudication committees must keep up with rapidly developing requirements as they receive potentially identifiable research data.
Investigating Enrollment Reliability with the Longboat Platform
Download the case study to learn if the Longboat Platform helps sites more accurately set and reach their patient recruitment targets.
Ensuring Recruitment and Compliance Success of an Evolving Rare Neuromuscular Disease Study
Find out how the Longboat Platform ensured not only recruitment success, but site and participant support and compliance.
Rare and Orphan Diseases in Regulated Development
In this webinar, gain an in-depth understanding of regulatory and clinical development challenges for rare/orphan diseases.
Beginner’s Guide to Single IRB Mandates
More governing bodies are starting to opt for single institutional review board (sIRB) review as a way to streamline research operations.
Why Keep HIPAA Separate from the Informed Consent Form
HIPAA is important to the informed consent process, and oftentimes, a standalone document is the most beneficial approach.
Regulatory Trends in Cell and Gene Therapies
Recent signals have indicated the FDA plans to provide greater support for cell and gene therapy research.
Understanding FDA’s Draft Guidance on Ethical Considerations for Involving Children in Clinical Trials
Until the 1980s, children were excluded from research studies. Now, FDA provides draft guidance on ethically including kids in trials.
FDA’s September 2022 NPRMs: What They Mean for Academia and Industry
FDA’s new NPRMs would harmonize certain IRB regulations with the HHS Common Rule. Find out what this could mean for sites and sponsors.
Modernizing Site Feasibility and Selection
An important decision impacting a multi-faceted study startup process is determining which sites to partner with for study conduct.
Unpacking IRB Innovations for Decentralized Clinical Trials
Ethical oversight committees continue to innovate to keep pace with the rapid changes and evolution of research conduct.