Research Operations
Defining Decentralized Clinical Trials and Understanding Their Nuances
It’s important to understand decentralized clinical trials are not one-size fits-all and oftentimes a hybrid approach is necessary. Read our latest blog outlining what to consider when rolling out decentralized clinical trials across multiple jurisdictions where laws, technological uptake, and populations will vary.
James Riddle and Luke Gelinas Explore Digital Health and Regulation
This podcast covers an array of topics as they explore how COVID has been a catalyst for change, what digital health means for running clinical trials, and how sponsors, CROs, sites, and IRBs can consider when reviewing new digital technologies as a result of COVID.
Leveraging a Central IRB Office to Improve Turnaround Times and Consistency
Building Remote Workflows within eRegulatory Document Management: Subject Binders & SOPs
Advarra eRegulatory Management System now supports the storage and remote monitoring of Subject Binders and SOPs, increasing compliance, and centralizing your study documents.
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.
How Technology Can Improve Regulatory Efficiencies During the COVID-19 Pandemic and Beyond
Sites and life sciences companies have quickly adopted remote workflows to keep trials moving, and these changes are sure to inform our “new normal” as we look forward.
Evaluating the Tolerability & Efficacy of Clinical Operations Processes
We all know there is scope for improvement in our day-to-day processes, but knowing where to start is not always obvious. Tried and tested operational practices can be applied at both the organizational and study levels to help make the clinical trial process more efficient and tolerable for everyone involved.
How Technology and System Integration Can Improve Your Billing Compliance
The consequences of inaccurate billing can be severe, and ensuring workflows are being followed by all teams across an institution can be a difficult process.
Clinical Trial Feasibility: Ensuring Success for Clinical Sites
With comprehensive research portfolios and a myriad of operational challenges to manage, it has never been more important for sites to approach research operations as a business.
GCP Assessment During COVID – “Did Your Clinical Trials Remain GCP Compliant During COVID-19?”
Almost a year into the COVID-19 pandemic, analyze how IRB submissions, informed consent, and remote monitoring practices have maintained GCP compliance.
10 Things Site Staff Told Us
Site staff are the operational hands and feet of your clinical study, and much of your success relies on their success.
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