Consulting - Advarra

Is GDPR Coming to the US? CCPA and Its Impact on Research

Remember on the older The Price Is Right game shows with Bob Barker, when the announcer would describe to the contestant they could win “a brand-new car!” and then proceed to describe the car? Part of the description was always that the car had “and California emissions.” Why was that? What was so special about California? Turns out the state of California had different, more restrictive, pollution rules from the rest of the country; and if you wanted to sell cars in California you had to meet the California standards. It was difficult for car manufacturers to produce cars separate just for California, so eventually the country normalized on one standard, which looked a lot like the original California emissions standard.

Q&A – The Must-Haves of FDA and Common Rule Reporting Requirements

In a recent webinar, Advarra regulatory experts discussed the must-haves of FDA and Common Rule reporting requirements. They reviewed the basics of what must be reported to whom—and when—for sponsors and investigators involved in IND studies, as well as requirements for identifying, reviewing, and reporting unanticipated problems and noncompliance to IRBs and Common Rule departments or agencies. Due to time constraints we weren’t able to answer all audience questions during the Q&A period, so our experts have answered some of the most popular questions in this blog.

3 Essential Elements of Change Management Within Clinical Research Operations At Your Research Site

The key to effective, productive change within a research institution lies at the nexus of people, process, and technology.

Getting “Engaged” in the Time of COVID

When using remote sites to perform clinical trial procedures, there are certain issues researchers must keep in mind, including whether those remote sites are considered to be engaged in research.

What Do Auditors Look for When Performing SDV and SDR?

Subject safety and reliability of data are paramount in clinical research. This blog outlines what auditors look for when performing source data verification (SDV) and source data review (SDR) during routine investigator site audits.

Developing a Clinical Trial Budget Following Medicare’s Clinical Trial Policy and Device Regulations

Developing and negotiating a clinical trial budget that applies Medicare’s rules and regulations involves many challenges. Find out strategies to assist with the process.

Q&A – Site and Patient Engagement

CEO Gadi Saarony and Deb Tatton, Parexel Senior Vice President of Global Clinical Operations, consider ways to improve site and patient engagement in this Fireside Chat Q&A blog part 2.

Q&A – The Evolving Role of Technology

In this Fireside Chat Q&A blog , CEO Gadi Saarony and Deb Tatton, Parexel Senior Vice President of Global Clinical Operations, share perspectives on technology’s evolving role in clinical research.

How Staff Augmentation Services Helps Centralize Site Services

Staff augmentation streamlines research operations, enabling centralized workflows that improve financial accuracy and enhance team collaboration.

Vendor Qualification vs Requalification Audits: What’s the Difference?

Different types of audits can be performed to support your vendor qualification and management program. These audits should be conducted using a risk-based approach. In this blog, we outline the difference between these types of audits and how to identify vendors that have the most potential risk for your program.

Making a Case for Interim HRPP Staffing

As much as we hate to admit it, many of us have been there…that moment when we suddenly realize “Oh no. I need to fill an HRPP position YESTERDAY. Help!”

Coverage Analysis: Standard of Care vs. What Medicare Covers

A thorough coverage analysis identifies billable items in clinical trials, balancing standard of care needs with Medicare’s complex billing guidelines.