Traditional clinical trial designs often delay progress due to rigid protocols and frequent amendments. Adaptive and platform trial models introduce flexibility and shared infrastructure, reducing startup delays, cutting costs, and enabling sponsors to conduct faster, more efficient research.
Over the past 14 years, Anna Carnevale, associate director of client services at Advarra, has seen her team grow from
Clinical research gives people hope. For some, it’s the chance to hold a new grandchild. For others, it’s walking a
Now that FDA has published the ICH E6(R3) Good Clinical Practice (GCP) guidance, aligning early with these requirements can prepare organizations for the future. ICH E6(R3) encourages ethics review committees to more intelligently apply their resources by enhancing efficiency without compromising participant safety or data integrity particularly regarding continuing review, informed consent, decentralized logistics, and data governance. Sponsors partnering with Advarra can be confident that their studies remain regulation-ready on both sides of the border today and E6(R3)-ready for tomorrow.
This white paper examines four KPIs most impacting timelines and budgets and offers strategies for effective communication and risk mitigation.
Overview Advarra, Inc., doing business as Advarra®, and any of our subsidiaries or affiliates (collectively, “Advarra”), provide this policy so
The U.S. Food and Drug Administration’s (FDA’s) recent draft guidance, “Considerations for the Use of Artificial Intelligence to Support Regulatory
Advarra partnered with PreHealth, a brand growth and experience agency, to create Braid, the identity for Advarra’s data and AI
The third revision (R3) of the ICH E6 Guideline for Good Clinical Practice represents a significant modernization of global clinical research standards. Research organizations must critically evaluate both their clinical priorities and operational procedures to ensure compliance.
The release of ICH E6(R3) in January 2025 marks the most significant evolution in Good Clinical Practice (GCP) guidelines in over a decade. More than a revision, E6(R3) marks a shift from traditional practices—making participant safety and data reliability not just priorities, but design drivers, and introducing risk-based proportionality as a foundational approach.
The release of ICH E6(R3) in January 2025 marks the most significant evolution in Good Clinical Practice (GCP) guidelines in over a decade. More than a revision, E6(R3) marks a shift from traditional practices—making participant safety and data reliability not just priorities, but design drivers, and introducing risk-based proportionality as a foundational approach.
Clinical research drives medical progress. Advarra ensures participant safety and ethical standards through expert IRB oversight for life-changing therapies.
