sponsors - Advarra

Clinical Trial Budget Negotiations: A View From Each Side

Budget negotiation success hinges on clear communication and early resource sharing, helping sites and sponsors align expectations and avoid costly delays.

g0e686729cd704541c2a368930df290b537b67045631d83764b52b2e257330593f413e9dcc527ac4848b6e875acf3c0f8_1280-257336.jpg

Good Manufacturing Practices: When Do They Apply?

Navigating cGMP application in investigational drugs can be complex. Learn how FDA guidelines help clinical teams maintain safety and quality from early trials to commercialization.

GxP Audits Guide for Successful Clinical Trials

A robust GxP audit program enhances regulatory compliance by ensuring quality and consistency across investigator sites, vendors, and internal processes in clinical trials.

Key Items Auditors Look for When Reviewing an Investigator Site File

Maintaining complete and compliant documentation while managing the complex processes and interactions of clinical trial conduct can be complicated. This blog outlines the details to look out for preparing your investigator site file (ISF) for an audit.

Understanding FDA’s 2024 Draft Guidance on DMCs

The FDA’s 2024 draft guidance emphasizes the critical role of independent DMCs in clinical trials, enhancing oversight, safety, and trial integrity.

Reporting to the IRB: Unanticipated Device Effects in Medical Device Studies

In this blog, we’ll take a look at what the regulations do and do not say about IRB reporting requirements and how Advarra has addressed some of the undefined “gray areas.”

Reporting to the IRB: Investigator Noncompliance

We often get questions about exactly what events should be reported to the IRB. We understand that “reportable events” can be tricky: some “events” are specifically referenced in the regulations, but lack a definition; some are covered in regulatory guidance documents; and some are “industry standard” that are neither an IRB regulation or IRB best practice/guidance. In this blog, we’ll look at what the regulations do and do not say about IRB reporting requirements and how Advarra has addressed some of the undefined “gray areas.”