Pitfalls of Chemistry, Manufacturing, and Controls in Investigational New Drug Preparation
Developing an investigational new drug (IND) application is a big milestone for organizations, especially small companies bringing their first drug
Consulting
Regulatory Fine Points: What Research Sites Need to Do for Part 11 Compliance
To maintain Part 11 compliance, research sites must validate electronic systems storing FDA-regulated records, safeguarding data integrity and accuracy.
Q&A: FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect
In a recent webinar, Advarra experts Constance Cullity and Michele Russell-Einhorn presented FDA Inspections of Clinical Investigators: Understanding the Process
Phase I Oncology Clinical Trials
In a recent blog, we described the complexity and uniqueness of Phase I clinical trials, outlining the fact that some
Study Startup Success for BioPharma and MedTech: Engage a Research Compliance Partner
A key element to successful study startup is identifying efficiencies to help meet critical milestones. Engaging with research compliance experts
The State of Clinical Trial Activation at Sites Report
Explore Advarra’s Study Activation Report to uncover roadblocks, survey findings, and solutions to streamline clinical trial activation at sites.
Defining Decentralized Clinical Trials and Understanding Their Nuances
Decentralization is one arrow in the quiver to modernize clinical trials.[1] Yet, owing to the varied approaches and possible components
FDA Inspection Readiness: After the Inspection
In the final part of the three-part FDA inspection readiness series, we will go into detail about what to expect
FDA Inspection Readiness: During an Inspection
In our previous blog, FDA Inspection Readiness: Preparing for an Inspection we reviewed how to prepare for a Food and
GCP Assessment During COVID – “Did Your Clinical Trials Remain GCP Compliant During COVID-19?”
We are now almost a year into the COVID-19 pandemic, and you may be asking whether your clinical trials remained
Informed Consent: When, Why, and How It’s Obtained
Informed consent isn’t just a formality—it’s an evolving process that safeguards participant autonomy and enhances study integrity from start to finish.
Q&A: Institutional Responsibilities Under a Federalwide Assurance
In a recent webinar, Advarra regulatory experts presented on the topic titled Institutional Responsibilities Under a Federalwide Assurance (FWA). Our