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Blog

New and Emerging CMS Policies: Medicaid’s New Clinical Trial Policy

June 30, 2023

Explore insights on new CMS policies & Medicaid's fresh clinical trial policy. Stay updated in a rapidly evolving healthcare landscape.

Blog

How to Design Digital Materials for Participant Engagement

July 21, 2021

Keeping a participant informed and engaged in any study is critical. This blog outlines how we can engage participants digitally.

Blog

Roles and Responsibilities of a Clinical Research Coordinator

September 22, 2020

Clinical Research Coordinators are tasked with many responsibilities throughout the day. Learn about balancing each role and responsibility effectively.

Abstract

Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative

December 20, 2019

Advarra Senior Consultant David Babaian, JD, was a co-author for an article appearing in Therapeutic Innovation and Regulatory Science.

Blog

Understanding the EU Clinical Trials Regulations Updates

March 17, 2022

The new European Union regulations have significant implications for sponsors submitting trials in the EU.

News

TriNetX and Advarra Partner to Provide Enhanced Site Selection Services

November 16, 2021

SiteIQ™ Plus Offering Equips Life Sciences Companies with Study Site and Principal Investigator Insights Paired with Patient Availability Information to...

Blog

Regulatory Considerations for Pharmaceutical Product Lifecycle Management

July 27, 2022

New FDA guidance (ICH q12) applies to pharmaceutical drug substances and products requiring a marketing authorization.

Blog

What Is a Screening Consent?

August 14, 2019

Study-specific screening consent is a subtype of informed consent, which ensures a research participant understands of the research and its risks.

Blog

Risk Assessment for use of Engineered Genetic Materials in Clinical Research

March 31, 2023

Learn why an institutional biosafety committee needs to complete a risk assessment for engineered genetic material in clinical research.

Page

Services For Sponsors & CROs

Advarra understands the unique needs of clinical research sponsors and contract research organizations (CROs).

Blog

Building Remote Workflows within eRegulatory Document Management: Subject Binders & SOPs

March 16, 2021

Advarra eRegulatory Management System now supports the storage and remote monitoring of Subject Binders and SOPs, increasing compliance, and centralizing your study documents.

Blog

How Paper and Electronic Source Data Meet ALCOA-C Principles

October 6, 2022

ALCOA ensures source data is safe and effective, but how does it differ for data collected on paper vs. electronically?