Nicholas Giokas’ Post

Learn how to optimize your trials with advice from global clinical research experts! Introducing Clinical Confidential, a new document series from MCRA’s Global Clinical Research Organization. In this series, we’ll reveal the interrelated requirements of clients developing novel healthcare technologies from a global perspective. Led by a team of industry experts and informed by the entire commercialization process, the series will help guide established companies and startups through the clinical trial labyrinth with the goal of maximizing the value of their healthcare innovations. #MCRA #clinicalresearch #medtech #medicaldevice #regulatory #machinelearning #FDAsubmission #digitalhealth Contact Us https://lnkd.in/egTEWYaV

The FDA has released guidance as part of its Real World Evidence Program to enhance regulatory decision-making on the effectiveness and safety of drug and biological products. It offers key considerations for sponsors and stakeholders when proposing to use electronic health records (EHRs) or medical claims data in clinical studies. Our latest snapshot reveals highlights from the guidance ⬇️ 1. Study Preparation 📝 - Decide your essential elements of study design in advance, submit protocols and statistical analysis plans, and maintain engagement with the FDA. 2. Data Sources 📚 - Check the relevance and reliability of data sources, clearly identify the study population, factors you are studying, outcomes, and confounders/effect modifiers. 3. Data Quality 📈 - Maintain high data quality throughout the data lifecycle, from collection to final dataset transformation. 4. Study Design 🧰 - Clearly define time periods and outline methods for patient inclusion/exclusion criteria.   5. Validation ✅ - Ensure accurate measurement of your study's variables. For more detailed information, refer to the FDA's guidance: https://lnkd.in/geANjjW7 See our snapshot here 🔗 https://lnkd.in/eiac7AdP #FDA #RealWorldEvidence #Pharma #Biotech #ClinicalStudies #EHR #RegulatoryScience #DrugSafety

Stay updated with the latest advancements in clinical trials! 📚 The ICH M4 Step 4 guideline 2024 brings significant improvements to streamline regulatory submissions. Dive into the comprehensive guidance and elevate your clinical research processes. #ClinicalTrials #Research #ICHGuidelines #RegulatoryAffairs #Medicalresearch #Zyfis #Stayupdated #Regulatorysubmissions

🎙️ Webinar Alert: US vs EU Regulatory Expectations for Combination Products Join us on 📅 April 4th, 2024, at 4:00 PM CET for a focused discussion with experts JOHN LOCKWOOD, Audrey TOULEMONDE, and Thomas Stover on the US and EU regulatory landscape for combination products. Key Takeaways: - Differences in US and EU regulations. - Impact of new regulatory guidance. - Insights into usability studies and clinical trials. - Bridging strategies and design control considerations. Don’t miss this opportunity to deepen your understanding of regulatory expectations.

🔮 𝗪𝗵𝗮𝘁 𝗺𝗮𝗸𝗲𝘀 𝗮 𝘀𝘂𝗰𝗰𝗲𝘀𝘀𝗳𝘂𝗹 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝘀𝘂𝗯𝗺𝗶𝘀𝘀𝗶𝗼𝗻 𝗳𝗿𝗼𝗺 𝗮 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘁𝗿𝗶𝗮𝗹 𝗽𝗲𝗿𝘀𝗽𝗲𝗰𝘁𝗶𝘃𝗲? (𝗣𝗮𝗿𝘁 𝟮 𝗼𝗳 𝟯) In this 8-minute clip and as part of our clinical trial educational video series, RQM+ Senior Vice President of Scientific Affairs Amie Smirthwaite, PhD, FRAPS and former FDA lead reviewer Ryan Randall continue their deep dive into this vital topic. 𝗞𝗲𝘆 𝗮𝘀𝗽𝗲𝗰𝘁𝘀 𝗰𝗼𝘃𝗲𝗿𝗲𝗱 𝗶𝗻 𝘁𝗵𝗶𝘀 𝗼𝗻𝗲 👇 – Challenges in demonstrating safety and performance/efficacy for devices – Differences between FDA and EU approaches to clinical evidence – The impact of evolving device designs on clinical studies – Importance of pre-submission meetings with regulatory bodies – Complexities of EU reimbursement – Strategies for dealing with small sample sizes in clinical data #RegulatoryAffairs #ClinicalTrials #MedTech #FDA #EURegulation #EUMDR #MedicalDevices

🚀 Reimagining Healthcare Innovation: A Call for New Regulatory Models 🚀 I recently had the pleasure of listening to an eye-opening podcast (linked in comments) featuring Vivek Ramaswamy and Balaji Srinivasan, where they explored the future of healthcare innovation and the role of regulatory bodies like the FDA. 🎧 🔍 Key Takeaways: 1. Regulatory Hurdles: Traditional regulatory processes can significantly delay and increase the cost of drug development and prevent those who could benefit most from receiving an intervention when time is of the essence. Eroom's Law illustrates how drug development costs have skyrocketed despite technological advancements. 2. Alternative Approaches: There’s a growing need for new regulatory models that are more aligned with the pace of innovation. Alternative approaches could streamline approval processes and accelerate access to new treatments. 3. Public Perception: The revolving door between the FDA and the pharmaceutical industry raises serious concerns about conflicts of interest and erodes public trust. When regulators transition to industry roles (or vice versa), it can create perceptions of bias, undermining confidence in the regulatory process. For new models to succeed, they must prioritize transparency and rebuild trust with the public. 💬 What are your thoughts on these ideas? - How can we overcome the barriers created by traditional regulatory bodies? - What would an alternative regulatory framework look like in practice? - How can we shift public perception to embrace innovative approaches to healthcare regulation? Let's open up the discussion and explore how we can collaboratively build a more dynamic, responsive healthcare system. Your insights and experiences are valuable—share your thoughts below! ⬇️ #HealthcareInnovation #FutureOfMedicine #Innovation

Many medical affairs teams want to measure their impact but focusing too much on activities rather than outcomes. To drive real change, it’s essential to commit to outcomes that truly matter, like increasing awareness of unmet medical needs or presenting data that challenges current clinical practices. At Acceleration Point, our Accelerated Insights program is designed to help teams define, measure, and align their work toward achieving those impactful outcomes. Let us help you commit to medical impact! Learn more here: 👉 https://lnkd.in/e5AvRCJ8  #MedicalAffairs #Insights #pharmainnovation #Pharma #Kwello

Dive deep into the regulatory landscape with industry experts John Lockwood, Audrey Toulemonde, and Thomas Stover, as they discuss key differences between the US and EU regulations, the impact of new guidance, usability studies, bridging strategies, and more. 🗓️ Date: April 4th, 2024 - 4:00 PM 🎙️ Topic: Know your market: US and EU regulatory expectations for combination products. Key Learnings: • Differences in regulation between the US and EU for combination products. • The impact of new regulatory guidance on the market space. • Considerations regarding usability studies and clinical trials. • The potential need for strategies to address bridging studies. • The co-existence of design control and drug development activities. Register now for this insightful webinar: 🔗 https://shorturl.at/lnBX7 Don't miss out on this opportunity to enhance your understanding of drug-device development. #PharmaLex #Webinar #RegulatoryExpectations #DrugDeviceDevelopment

Dive deep into the regulatory landscape with industry experts JOHN LOCKWOOD, Audrey TOULEMONDE and Thomas Stover, as they discuss key differences between the US and EU regulations, the impact of new guidance, usability studies, bridging strategies, and more. 🗓️ Date: April 4th, 2024 - 4:00 PM 🎙️ Topic: Know your market: US and EU regulatory expectations for combination products. Key Learnings: • Differences in regulation between the US and EU for combination products. • The impact of new regulatory guidance on the market space. • Considerations regarding usability studies and clinical trials. • The potential need for strategies to address bridging studies. • The co-existence of design control and drug development activities. Register now for this insightful webinar: 🔗 https://shorturl.at/lnBX7 Don't miss out on this opportunity to enhance your understanding of drug-device development. #PharmaLex #Webinar #RegulatoryExpectations #DrugDeviceDevelopment

Throughout the #LifeSciences industry, leaders are working to use technology to improve clinical research, expand access to clinical trials, improve patient representation, and enhance drug safety. Read Seema Verma’s article for key areas to watch in 2024. https://lnkd.in/gmVdTuY3