Regulatory Fine Points: What Research Sites Need to Do for Part 11 Compliance
To maintain Part 11 compliance, research sites must validate electronic systems storing FDA-regulated records, safeguarding data integrity and accuracy.
Research Operations
How to Be Research Ready: Today and Beyond
Research readiness ensures that your organization can accept, activate, and adapt to new studies and opportunities no matter the regulatory circumstances.
Building a Foundation for Regulatory Success in the Post-Pandemic Landscape
The past year has been one of the most challenging ever for those working in healthcare and clinical research. The
Q&A: FDA Inspections of Clinical Investigators: Understanding the Process and What to Expect
In a recent webinar, Advarra experts Constance Cullity and Michele Russell-Einhorn presented FDA Inspections of Clinical Investigators: Understanding the Process
Phase I Oncology Clinical Trials
In a recent blog, we described the complexity and uniqueness of Phase I clinical trials, outlining the fact that some
Study Startup Success for BioPharma and MedTech: Engage a Research Compliance Partner
A key element to successful study startup is identifying efficiencies to help meet critical milestones. Engaging with research compliance experts
3 Strategies to Successfully Engage Participants in Your Trial
Engaging participants and creating a positive experience throughout your clinical trial increases protocol compliance, participant retention, and referrals.
Study Activation Survey Results: Budget Negotiation
Budget negotiations reveal hidden costs and extended timelines, underscoring the importance of efficient processes for clinical trial success.
Study Activation Survey Results: Medicare Coverage Analysis (MCA)
MCA timelines impact trial activation efficiency, with staffing shortages a key barrier. Many sites find sponsors receptive to covering MCA-related costs.
Q&A Part II: Clinical Trial Feasibility: Ensuring Success for Clinical Sites
In a recent webinar, Advarra experts Wendy Tate and Cheryl Byers provided considerations for building an effective feasibility process, including
Q&A Part I: Clinical Trial Feasibility: Ensuring Success for Clinical Sites
In a recent webinar, Advarra experts Wendy Tate and Cheryl Byers provided considerations for building an effective feasibility process, including
The Impact of Public Perception of Clinical Research
Undoubtedly one of the biggest news stories around the world during the past year has been the one surrounding the