Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation
Submitting an Investigational New Drug (IND) application for the first time? Consider three common CMC pitfalls that may impact submission.
Social Media for Research Recruitment: Ethical and Practical Aspects
Luke Gelinas, IRB Chairperson at Advarra, addresses ethical and practical issues involved with social media recruitment.
Regulatory Fine Points: What Research Sites Need to Do for Part 11 Compliance
Summary of James Riddle's Presentation at SQA, which outlines considerations for sponsors when ensuring 21 CFR Part 11 compliance at sites.
World’s Largest CRO Leverages Partnership With Integrated Central IBC to Initiate Sites in COVID-19 Vaccine Research at Warp Speed
Advarra’s IRB and IBC reviews and Gene Therapy Ready site network helped reduce study startup timelines and delivered trial results to the sponsor quicker than expected.
Q&A: FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect
Q&A from our 4/21 webinar outlining what to expect in an FDA inspection and how to have a more positive experience.
Q&A Part II: Clinical Trial Feasibility: Ensuring Success for Clinical Sites
Part 2 of Q&A from the Clinical Trial Feasibility: Ensuring Success for Clinical Sites webinar outlining why it is important for sites to approach research operations as a business.
Q&A Part I: Clinical Trial Feasibility: Ensuring Success for Clinical Sites
Q&A from the Clinical Trial Feasibility: Ensuring Success for Clinical Sites webinar outlining why it is important for sites to approach research operations as a business.
FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect
A Food and Drug Administration (FDA) inspection of a clinical investigator can occur at any time. The FDA conducts inspections of clinical investigators to verify clinical trial data submitted to FDA; to ensure that the rights, safety, and welfare of human subjects enrolled in FDA-regulated clinical trials are protected; and to assess regulatory compliance.
Leveraging a Central IRB Office to Improve Turnaround Times and Consistency
Legislation to Advance Equality and Inclusion in Oncology Clinical Trials
The Clinical Treatment Act and Henrietta Lacks Enhancing Cancer Research Act aims to increase diversity in oncology clinical trials
Remote Monitoring: Study Compliance in a Changing World
Effective remote monitoring plans enable sites and sponsors to maintain trial participant safety, data quality, and data integrity. With limited availability to access research sites in person over the past year, sponsors and monitors rapidly changed how they review study procedures, subject status, and study progress at research sites.
FDA Inspection Readiness: After the Inspection
Preparing for an FDA inspection and enabling a site-specific process to support it is important. Learn more about what to expect and implement after an FDA inspection is completed at your institution.