Research Operations
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.
Setting Yourself up for Success During Investigator-initiated Trials
This eBook shares tips and best practices to guide researchers through the investigator-initiated trial process while staying compliant.
Addressing Decentralized Pre-Enrollment Challenges for Sites and Site Networks
Learn key processes and tools for your team to use to ensure your organization operates at peak performance.
Roundtable: Perspectives on the FDA Guidance for Clinical Decision Software
Clinical decision support (CDS) software is a challenging regulatory space. Conquer the confusion with this roundtable discussion.
Yale Enhances Patient Safety, Billing Workflows with OnCore and EMR Integration
Read how Advarra created an integration connecting the OnCore CTMS with Yale’s EMR system to support a compliant billing process.
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.
Site Streamlines Operations with Advarra EDC Study Design Service
Advarra’s Electronic Data Capture (EDC) Study Design Service was the solution to delivering high-quality eCRF builds to research staff.
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.
Budget Negotiation 101
Clinical trial costs vary from each site, and a prolonged budget negotiation process can affect the startup timeline.
Keys to Unblocking the Innovation Bottleneck in Research
As the clinical trial industry has evolved in the past decade, it’s invited more complexity into operations and workflows.
Inspection Readiness: Before. During. After
This webinar will cover successful strategies for a proactive approach to FDA inspections before, during, and after.
How the IND 30-day Hold Impacts Clinical Trial Activities
Find out what research activities can and cannot be conducted during the Investigational New Drug (IND) 30-day hold period.
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