Sarah Bailey’s Post

🎉 Introducing the Remap JCA Advisor  At Remap Consulting, we’re all about making the complex simple for our clients. That’s why we’re excited to share the launch of the Remap JCA Advisor, an AI-powered tool designed to help stakeholders better understand the European Union Health Technology Assessment (EU HTA) processes.  This tool aims to simplify the complexities of the Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JSC) processes, offering:  ✅ Clear Guidance: Detailed insights into EU HTA regulations and procedures.  ✅ Curated Knowledge: Reliable information sourced from trusted and up-to-date references.  ✅ Ease of Use: A user-friendly interface for intuitive navigation and seamless information retrieval.  We hope this tool will provide valuable support to those preparing for or engaging with EU HTA requirements.  👉 To learn more and explore the tool contact us contact@remapconsulting.com   We’d love to hear your thoughts as we continue to refine and improve how we support stakeholders in this space. #EUHTA #HealthTech #Innovation 

Are you struggling to find answers to your JCA and JSC questions? Do you want a simple and easy way to navigate the complexities? We've developed a free AI tool to help you get the information you need fast. Drop me a line or contact us contact@remapconsulting.com to get access

Systematic literature reviews (SLRs) are typically required as part of the health technology assessment (HTA) process, but the focus and mandatory  requirements of SLRs vary by HTA body. Maverex investigated the SLR requirements of eight HTA agencies around the world. Read below to see what we found. Early strategic planning of SLR requirements, including engaging in early scientific advice with HTA agencies, can ensure SLRs fulfil the requirements for multiple HTA bodies in a timely and efficient manner. Contact us today to speak to one of our HTA and SLR experts, or if you would like further information. This research was presented at ISPOR 2024. #SLR #HTA #MarketAccess #TechnologyAppraisal

Clinical trial start-up at AMCs and health networks can be challenging, especially with paper-based processes or outdated legacy systems slowing things down. Discover how eReg/eISF solutions streamline operations, accelerate clinical trial cylce times and stregthen compliance. Check out the full story here: https://lnkd.in/dUPGj9ZY #ClinicalTrials #eReg #eISF #Efficiency #Compliance #BetterData

Clinical trial start-up at AMCs and health networks can be challenging, especially with paper-based processes or outdated legacy systems slowing things down. Discover how eReg/eISF solutions streamline operations, accelerate clinical trial cylce times and stregthen compliance. Check out the full story here: https://lnkd.in/d7EiHZV2 #ClinicalTrials #eReg #eISF #Efficiency #Compliance #BetterData

📢 The EU Health Technology Assessment Regulation has taken a significant step forward with the publication of two new guidance documents. ➡ Guidance on Outcomes: This document will aid Member States’ authorities in defining the scope of joint clinical assessments and ensure assessors report all necessary elements for national appraisal. ➡ Guidance on Reporting Requirements: It addresses how assessors should handle multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments. These documents are crucial for health technology developers as they prepare their submissions for assessment. Adopted at the 9th meeting of the Member State Coordination Group on Health Technology Assessment, these guidelines promise to streamline processes and enhance collaboration. For more details, visit the official announcement page: https://lnkd.in/d3aiK_We These guidance documents will also be covered in our upcoming webinar on 9th July: https://lnkd.in/dzW67XMr #HTA #EUJCA #StatisticalGuidelines #JCA 

These steps towards implementation of the JCA are critical to embedding this in the way we work.... #heor #marketaccess #avalerehealth

Collaboration on open-source statistical tools has done wonders to break down pre-competitive silos across companies. We're now at a stage where open-source ecosystems can successfully produce complete regulatory submission packages.   The presentations and panel discussions at yesterday's 'Openstatsware - How can we build a scalable ecosystem?' session at the 2024 EFSPI Regulatory Statistics Workshop celebrated the hard work of all the passionate people involved.   Could we do the same thing for Health Technology Assessments (#HTA) submissions?   Yes!   With #EUHTA Joint Clinical Assessment right around the corner, now is exactly the right time to connect the dots and take open-source into an HTA dossier production setting.   We should aim to make such an effort maximally inclusive by design.   If we get it right, open-source collaborations can be a vehicle for the HTA methodology capability building that needs to happen both across companies and HTAs.   An open-source HTA ecosystem built with interoperability in mind could be a key enabler to seamlessly integrate CROs into sponsor systems, to optimize speed and agility.   Lastly, it would increase transparency around HTA analytics work and contribute towards the (EU) HTA aspirations of bringing new medicines and technology to patients faster.   Lots of work needs to be done to make all of this happen. The PSI/EFSPI HTA Special Interest Group is just one of the places where we have a track dedicated to this. More and broader working groups will come in the near future!   #EFSPI #PSIcommunity #HTAESIG #EUHTA

AMCs and health networks face big challenges during trial start-up, often slowed down by paper-based processes or outdated legacy systems. Learn how eReg/eISF platforms can accelerate clinical trial cycle times, boost compliance, and improve collaboration for a smoother start-up experience right here: https://lnkd.in/eB6qC_WN #ClinicalTrials #eReg #eISF #Efficiency #Compliance #BetterData

AMCs and health networks face big challenges during trial start-up, often slowed down by paper-based processes or outdated legacy systems. Learn how eReg/eISF platforms can accelerate clinical trial cycle times, boost compliance, and improve collaboration for a smoother start-up experience right here: https://lnkd.in/e85jJhJy #ClinicalTrials #eReg #eISF #Efficiency #Compliance #BetterData