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Unlocking Insights: EVERSANA’s Value & Evidence Team’s Impact on Economic and Healthcare Resource Utilization Outcomes in Robotic vs. Manual Total Knee Arthroplasty
The use of robotics in surgical procedures is becoming increasingly popular, with the potential to reshape the landscape of modern surgery. In total knee arthroplasty (TKA), the increased adoption of robotics has improved clinical outcomes, including…
Pioneering the Path: How Medical Affairs is Charting the Course for Pre- and Post-Launch Strategies
Early involvement of Medical Affairs in the product lifecycle is not just beneficial – it is mission critical. In the swiftly changing realm of advanced therapies like biosimilars, rare disease molecules, and cell and gene therapies,…
Establishing the Pricing and Value Proposition of AI/MedTech Solutions in Healthcare
Authors: Prachi Singh, Senior Consultant; Robin Arnold, EVP, APAC Consulting Unlock the future of healthcare with our white paper, “Establishing the Pricing and Value Proposition of AI/MedTech Solutions in Healthcare.” Discover the essential components of pricing…
Navigating the Frontier: Generative AI Revolutionizing Healthcare and Life Sciences
In the dynamic landscape of healthcare and life sciences, the integration of cutting-edge technologies has become paramount. Among these innovations, Artificial Intelligence (AI) stands out as a transformative force, reshaping everything from drug discovery to patient…
Harnessing the Commercial Promise of Prescription Drug Use-Related Software (PDURS)
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John Kutz , Martin Culjat, PhD , Justin Averback , Calvin Fujimoto , Joey Pecoraro on 3 月 7, 20243/7/24
The FDA’s draft guidance on Prescription Drug Use-Related Software (PDURS) offers pharmaceutical manufacturers a novel strategy to enhance a drug’s label by enabling an HCP to prescribe software alongside the drug at the HCP’s discretion. The…
Current Trends in Medical Review of Promotional and Non-Promotional Materials
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Michael DeLuca , Varun Pandey, PhD , Mary Mehrabian, PharmD, BCGP, BCMAS on 3 月 7, 20243/7/24
Medical Information (MI) plays a crucial role in addressing inquiries from healthcare professionals, payors, and patients/caregivers and ensuring pharmaceutical products’ safe, effective, and appropriate use. However, MI teams often have other important responsibilities beyond the scope…
Future-Proofing Demands Proof: How Innovators Are Transforming Pharma Commercialization
In the fast-evolving landscape of pharmaceuticals, staying ahead demands more than just adapting to today’s challenges – it requires pioneering the future. Introducing intentional innovation, the sweet spot where blue-sky imagination meets on-the-ground effort. It’s being able…
Q&A: Enhanced Protection and Consistency for PRCI in Canada
Introduction At EVERSANA, we’re at the forefront of regulatory work in Canada, and recently, our team has been delving into the realm of PRCI (Public Release of Clinical Information) in Canada and submission Policy 0070 (Regulation…
The Looming Legacy of Software as a Medical Device (SaMD) Misclassification Under Medical Device Directive (MDD)
Regulation (EU) 2017/745, the Medical Device Regulation (MDR), sent shockwaves through the industry with its stricter oversight and transparency demands. While the implementation challenges like delays, notified body capacity, and EUDAMED implementation have dominated discussions, a…
Navigating Successful Partnerships in the Pharmaceutical Industry: Insights from Shorla Oncology CEO Sharon Cunningham
In the ever-evolving landscape of the pharmaceutical industry, forging successful partnerships and collaborations is a cornerstone of achieving groundbreaking advancements and bringing innovative treatments to patients in need. However, navigating through the myriad of advisors, consultants…