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How can wearable #digitalhealth technologies (DHTs) add value to your clinical development program? DHTs can help increase opportunities for participation in #clinicaltrials and can help capture data to inform safety and efficacy - check out ActiGraph's guide that helps sponsors break down this guidance and prepare for #regulatory submissions:

We are excited to see the FDA release their final guidance, "Digital Health Technologies for Remote Data Aquisition in Clinical Investigations.” 📗ActiGraph has put together a practical guide for clinical researchers that breaks down the FDA’s DHT guidance: https://hubs.la/Q02hcY9b0 We hope this resource, which includes checklists and key considerations for preparing regulatory submissions, helps sponsors maximize the value that DHTs can bring to their development programs. #FDA #regulatory #digitalhealthtechnology #clinicaltrials

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We are at the dawn of a new era for European Health Technology Assessment (HTA), and the recent publication of the draft Joint Clinical Assessment (JCA) for medicinal products Implementing Act (IA) brought us one step closer. In this Insights Brief, we explore what has changed in the IA on JCA, what has not been addressed, and how to prepare for 2025 and beyond. https://bit.ly/4bvacsk #HTA

Effective Sponsor Oversight: Ensuring Clinical Excellence! In the dynamic landscape of #clinicalresearch, sponsor oversight emerges as a critical linchpin. It’s not merely about ticking boxes; it’s about orchestrating a symphony of safety, quality, and compliance. 🔍 Why Sponsor Oversight Matters: 1. Patient Safety: Ensuring the well-being of trial participants is non-negotiable. Oversight bridges the gap between protocols and real-world execution, safeguarding those who entrust us with their health. 2. Data Integrity: High-quality data fuels scientific progress. Rigorous oversight ensures that data collection, management, and reporting align with best practices and regulatory standards. 3. Regulatory Compliance: The inspector’s question looms: “How have you ensured compliance?” Our answer lies in meticulous oversight—documented, proactive, and aligned with ICH E6 (R2) and EU Clinical Trial Regulation 536/2014. 🌐 The Art of Oversight: Imagine it as a finely tuned instrument. We harmonize preclinical insights, manufacturing perspectives, and #clinicalstudy design. The result? A symphony of confidence in our trial conduct. 🎶 🎓 Learn More: Explore our comprehensive course on Getting the Right Level of Sponsor Oversight. Discover practical strategies, regulatory insights, and real-world examples here: https://lnkd.in/ece42RiW 📧 Contact us at info@eccrt.com #Training #SponsorOversight #ECCRT #RegulatoryAffairs #EUCTR

Real World Evidence generation through non inteventional studies can support robust Randomised Clinical Trials. EMA have published a draft a reflection paper for consultation to consider the methodology for design of non inteventional studies to ensure robust data generation. #regulatory #realworldevidence https://lnkd.in/esPQ3M9J

Read the latest news from Science & Engineering Health Technologies Alliance (SEHTA) Strategic provider for #medicaldevice, #digitalhealth and #IVD #regulatory, #clinical and #quality activities. 👇 👇 👇

Science 37 recently underwent a successful FDA Inspection focusing on critical areas and documentation of its Virtual Site model for clinical research. Conducted between February 26 and March 6, 2024, the inspection included, but was not limited to, the Science 37 Metasite™ model and internal processes, technology utilized to support each trial, data integrity, efficacy, subject safety, protocol deviations, collaboration across teams, and Principal Investigator oversight. The FDA inspectors: - Reported no significant issues identified (“No Action Indicated”) - Reported no objectionable conditions or practices identified “This inspection is a demonstration of our daily commitment to doing high-quality, auditable, submission-level research, and being inspection ready at all times. Earning the confidence of FDA inspectors sends a powerful message to study sponsors and CROs in need of quality, compliant data and research acceleration,” commented Irena Lambridis, VP, Head of Quality Assurance & Compliance at Science 37. Read the press release: https://lnkd.in/gennmtfb #FDAInspection #pressrelease #clinicalresearch #clinicaltrials #clinicalstudies #healthcare #virtualtrials

Compliant medical events are important, but equally key, is the materials that accompany both these meetings, and the wider study. They too must adhere to strict regulatory requirements, which can change often, and also vary by country. In our latest edition of SWM Says… Ritika Sharma, Scientific Programme Director at SWM Partners shares some of the high level considerations to keep in mind when creating compliant medcomms. #SWMPartners #compliance #regulations #medcomms #content #medicine

The Health Technology Assessment Regulation (HTAR) of 2021/2282, which was implemented in 2022, will be gradually enforced upon companies starting from January 12, 2025. This regulation primarily focuses on medicinal products and medical devices and involves two significant activities at the EU level.   1. Joint Clinical Assessment (JCA): This entails a partial evaluation of health technology assessment, providing insights into the clinical relative effectiveness and safety of the products. 2. Joint Scientific Consultation (JSC): This activity is comparable to regulatory Scientific Advice and aims to facilitate collaboration and consultation on scientific matters.   Click on the link below to read the white paper where Sigrid Klaar, NDA Advisory Board member describes the JCA procedure for medicines. #HTAR #HTA #JCA #regulatoryaffairs #regulatoryconsultancy #NDAGroup