Blog
Developing a Clinical Trial Budget Following Medicare’s Clinical Trial Policy and Device Regulations
Learn tips for developing and negotiating a clinical trial budget according to Medicare’s rules and regulations for device and drug clinical trials.
IRB Review of Virtual Trial Technologies
What are some of the key issues IRBs face when reviewing research that includes virtual trial technology? Read more:
Q&A – Site and Patient Engagement
CEO Gadi Saarony and Deb Tatton, Parexel Senior VP of Global Clinical Operations, discuss site and patient engagement. Read more:
Q&A – The Evolving Role of Technology
CEO Gadi Saarony and Deb Tatton, Parexel Senior VP of Global Clinical Operations, discuss the evolving role of technology in research. Read more:
How Staff Augmentation Services Helps Centralize Site Services
Recently, an Advarra customer utilized the Staff Augmentation Services to assist on a financials roll-out, including centralizing financial services.
Accelerating the Recovery – Design and IRB Review of Safety Monitoring Plans During COVID-19
COVID-19 is rapidly changing the way research is conducted, namely how to conduct effective participant safety monitoring at a distance. Read more:
Vendor Qualification vs Requalification Audits: What’s the Difference?
Audits to support your vendor qualification and management program should be conducted using a risk-based approach. Read more:
The Opioid Crisis in America
Combating the opioid crisis requires urgent, evidence-based approaches that address clinical, research, and education issues. Read more:
Making a Case for Interim HRPP Staffing
Don't wait to fill an HRPP position until it's too late. Understand the risks of an understaffed HRPP and how interim staffing support can help. Read more:
Coverage Analysis: Standard of Care vs. What Medicare Covers
Learn more about coverage analysis, the process to determine if an item or service is part of a patient's standard of care or covered by Medicare.
Good Manufacturing Practices (cGMP): When Do They Apply?
When do current Good Manufacturing Practices (cGMP) regulations apply? Read more for FDA expectations for the application of cGMP to investigational drugs:
Fitting Your Needs: Pandemic-Proofing Protocols
The COVID-19 pandemic forced organizations to adjust to continue high-quality research, positioning research to be more patient centric and streamlined.