DistillerSR

Setting up a standardized framework to deal with vast volumes of data from heterogeneous data sources is essential for pharmacovigilance because it ensures consistency and accuracy in adverse event reporting, improves data integration and analysis. It also facilitates regulatory compliance and global collaboration while enhancing patient safety, and increasing operational efficiency. Michael Braun-Boghos, Senior Director Safety Strategy at Oracle Life Sciences, points out “The framework’s primary objective is to harmonize data management and signal detection by offering a unified structure for data and insights management. It effectively eliminates the existence of silos and replaces scattered Excel spreadsheets.” Watch the webinar Literature Surveillance Best Practices for Pharmacovigilance where Michael is joined by Andrew Purchase, Director of Pharmacovigilance at ICON plc and DistillerSR CEO, Peter O'Blenis as they discuss best practices and approaches to data harmonization for #pharmacovigilance.  Learn more https://bit.ly/3S4ict6 #LiteratureMonitoring #AIinhealthcare #LiteratureReviews #systematicliteraturereviews #Pharma

Harmonized data leads to predictive and prescriptive analytics, accelerating new market opportunities and enhancing patient safety and outcomes. As one of the speakers at #EM24’s “Navigating MedTech’s Innovation Evolution Through AI-Enabled Integrated Evidence Management” points out: “When collecting data from multiple sources throughout the medical device lifecycle, the first step to ensure teams can leverage this vast amount of information is standardization and coming up with a “data dictionary” to enable AI models while connecting multiple databases.” Watch #medicaldevices industry experts Julie Pritchard-Hedtke, President at Avio Medtech Consulting, Christa Goode, Worldwide Scientific Operation Director at Johnson & Johnson, Rea Castro, MD, MPH, Director of Medical Affairs at QuidelOrtho, and Sepanta Fazaeli, PhD, Clinical Systems & Medical Data Lead at Stryker, as they discuss the importance of data harmonization, and their journey towards adopting an integrated evidence management approach within their own organizations: https://bit.ly/4eTgYuF

The introduction of #eumdr was the catalyst for a major transformation at Stryker, led by Sepanta Fazaeli, PhD, Clinical Systems and Medical Data Lead at the Trauma and Extremities division. Here's how #DistillerSR improved the team's literature evidence management efficiency by 70%: 💡 Significant Efficiency Gains: DistillerSR standardized forms and templates, minimized manual tasks, and streamlined processes from initial screening to data extraction, and creation of clinical evaluation documents to support regulatory submissions. 💡Enhanced Compliance and Data Management: EU MDR required stricter compliance and comprehensive documentation throughout the medical device lifecycle. DistillerSR's scalable platform facilitated compliance, enhanced data quality, streamlined regulatory submissions, and improved audit readiness. 💡 Improved Cross-Functional Collaboration: DistillerSR effectively dismantled data silos within Stryker, promoting cross-functional data reuse and collaboration. This holistic approach to evidence management led to greater efficiency, consistency, and a collaborative culture, ultimately boosting productivity while enabling data-driven decision-making. Read the case study to learn more about how DistillerSR introduced a new era of efficiency and collaboration: https://bit.ly/3RTI8HV

“#AI is going to make some #SLR work quicker and easier to do because the machine will do it, but the important thing is to have trained people asking the questions, and working out what we want the AI to do and then trained people interpreting the results,” explains Elisabeth Fenwick, Chief Scientific Officer at OPEN Health. “It isn’t a case that you can feed data into a machine and out comes the answer and it’s done." Great article by our partners at OPEN Health, who we presented with on this very topic at the recent Health Technology Assessment international (HTAi) conference in Seville. DistillerSR

AI classifiers can significantly expedite and improve the accuracy of systematic literature reviews. Here are 5 benefits that top the list: 1️⃣ Speed and Accuracy: AI classifiers can reduce screening time by over 50%, ensuring faster and more accurate reviews. 2️⃣ Enhanced Focus: By automating repetitive tasks, AI allows reviewers to concentrate on the most relevant and high-quality studies. 3️⃣ No Coding Required: AI classification is a no-code solution, making it accessible to all reviewers without the need for programming skills. 4️⃣ Scalability: Create and apply an unlimited number of classifiers across various projects, streamlining the review process. 5️⃣ Quality Control: Use classifiers as a second reviewer to check for any errors and be more confident in your results. Learn how these benefits play out in practice at the AI Classifiers LinkedIn Live recording with DistillerSR customers Rosie Morland from Excerpta Medica BV - Adelphi Group and Remon van den Broek from Adelphi Group. https://bit.ly/3Rcu8bf #AIClassifiers #SystematicReviews #SLRs #DistillerSR #MedDev #IVOR #Pharma

Very interesting insights from McKinsey & Company on #GenAI in #pharma. Thank you for sharing, Chris Wright. The article explores how AI is moving from hype to reality, transforming drug discovery and development. My 2 key takeaways: 1) there is a clear opportunity to apply AI into R&D processes, enhancing efficiency and innovation. One Canadian 🇨🇦 company I have been following to this effect is BenchSci 2) as AI capabilities grow, so does the potential to revolutionize treatment discovery and patient outcomes. Molecular design, optimizing clinical trials, and personalizing treatment are just a few examples of areas that are ripe for AI disruption. What other business processes can you envision AI enhancing efficiency, helping cut costs, and bringing new therapies to market faster?

Four reasons why streamlined systematic literature review processes are an important part of the health intervention lifecycle:     1️⃣ A systematic literature review is one of the primary information streams feeding into health technology assessments (HTAs). It provides a complete synthesis of all relevant studies related to a particular topic in a transparent, verifiable manner. This essential information will subsequently influence health assessment outcomes. 2️⃣ Health technology assessments are critical for a big picture evaluation of the value of health interventions, considering critical aspects like clinical efficacy, safety, and cost-effectiveness. 3️⃣ As the demand for health technology assessments  continues to rise, so does the pressure on regulatory bodies to enhance the efficiency of their processes. Some of the acute challenges associated with systematic literature reviews for HTAs  are information overload, time constraints and the need for transparency and accuracy. 4️⃣ Automation can facilitate the entire literature review lifecycle, from search and screening to full-text retrieval, data extraction, and reporting. SLR software automates the management of literature collection, triage, and assessment using intelligent workflows that can be configured and modified to suit reviewer needs. Read the business brief to gain greater insight into how systematic literature review automation can enable up to 80% faster reviews and streamline HTAs: https://lnkd.in/gkBiyJ6P #medicaldevices #evidence #DistillerSR #HEOR #systematicliteraturereview #MedDev #IVOR #pharma

Key takeaways from the DistillerSR team, from #medtech Summit Europe in Brussels: 💡 The newly-adopted EU AI Act is expected to impose penalties of up to 7% of global revenues for violations. Many sessions highlighted the impact of this regulation and ISO 42001 on medical device manufacturers, stressing the need for a robust enterprise-wide compliance strategy. 💡 Orphan devices often address rare conditions and serve smaller patient populations and the difficulty to gather sufficient clinical evidence to meet EU MDR's rigorous requirements translate into an even more complex and lengthy regulatory compliance path. Addressing these challenges and market access barriers require targeted efforts to improve regulatory processes, provide financial incentives, and enhance the support for their development and approval. 💡 EUDAMED's new 2029 expected timeline was met with skepticism as go-live and mandatory use of the modules have been postponed several times. Data privacy was one of the main concerns raised by manufacturers in light of the current "voluntary" use. "I don't want to put my IP data in EUDAMED if my competitor will have access to it and if they have no obligation to put that information there as well..." was a recurring comment during coffee breaks. 💡 AI-enabled technologies are becoming critical for managing the ever-evolving regulatory landscape while increasing operational efficiency. #DistillerSR user Sepanta Fazaeli, PhD, Clinical Systems and Medical Data Lead at Stryker: "If it is tedious and redundant, automate it." 💡 Point solution software is dead. Manufacturers expect to input data into a single platform and get multiple outputs to serve cross-functional needs. #DistillerSR user Melinda Christensen, Director of Medical Device Development at Laerdal Medical: "If it's just going to solve part of the problem it is not worth the time and investment. Look for a single platform that will scale with your requirements, serve multiple teams, and integrate seamlessly with your existing tech stack." 💡 Various sessions were focused on data quality and the importance of data harmonization to ensure alignment with international standards and regulatory requirements, and facilitate market access. DistillerSR customer Elizabeth Gfoeller, Corporate Director, Regulatory Affairs at MED-EL: "If the data is consistent, reusing it from one regulatory submission to the next is much easier. Every market has specific regulatory requirements but in this scenario we are not starting from scratch and that saves a significant amount of time." 💡 Sixty-five per cent of the audience at one of the EU MDR sessions stated that their biggest challenge is fulfilling clinical evidence requirements for regulatory submissions followed by document management and data harmonization. Thank you Comptoir des Galeries for another memorable gastronomic experience and Bassil Akra for that unforgettable Lebanese meal (food for days) with new friends from MED-EL!

Navigating the complexities of the European Union Medical Device Regulation (EU MDR) can be time consuming, especially when it comes to conducting thorough literature reviews. These reviews are not only a pre-market approval regulatory requirement, but also a cornerstone of post-market surveillance. Here are 7 key best practices for EU MDR-compliant literature reviews: 1️⃣ Define the Research Question: Defining an appropriately scoped research question is a critical component of the literature review. Research questions that are too broad may return a large volume of  references that will need to be qualified. 2️⃣ Search Relevant Databases: Diversifying databases to include multiple sources will ensure that all relevant and current clinical data is included in the literature review for the device under evaluation. 3️⃣ Screen References for Relevance: The EU MDR outlines methods for setting up the literature review screening guideline. This part of the protocol is critical in demonstrating to auditors that manufacturers are following a robust and repeatable process and can justify the inclusion or exclusion of specific data. 4️⃣ Retrieve Full-Text Articles: Full-text content of each article should be appraised and the methods of full-text retrieval should be outlined in the literature review protocol. 5️⃣ Extract and Appraise the Quality of the Data: Qualifying the information retrieved from multiple sources is another crucial step to ensuring that medical device manufacturers fully understand the validity and applicability of evidence-based data. 6️⃣ Document Purpose and Methods: The purpose and methods should all be documented in the literature review protocol, as outlined in the EU MDR. A robust, easily traceable literature review protocol will ensure repeatability and transparency in audits, increasing the likelihood of success. 7️⃣ Monitor for New Literature and Adjust the Research Question: The research question supports current product safety and clinical use but may need to be revised in the event of new adverse events or literature content. Read the full business brief for additional insights:  https://bit.ly/4bigDhT #EUMDR #SLRs #Medicaldevices #DistillerSR  #systematicliteraturereview #MedDev

❓ Why should #medicaldevice manufacturers invest in tools like DistillerSR to improve their #Evidence Synthesis processes? 1. Regulatory Compliance: Enhanced evidence synthesis tools help manufacturers meet stringent regulatory requirements by ensuring robust and transparent data analysis and synthesis, which is crucial for obtaining and maintaining #MDR #IVDR and #FDA regulatory approval. 2. Quality Assurance: Investing in evidence synthesis tools ensures the reliability and quality of the data used in clinical evaluations and submissions. This leads to more accurate assessments of safety and effectiveness, reducing risks associated with product development and post-market surveillance. 3. Competitive Advantage: manufacturers can differentiate themselves by producing faster, higher-quality evidence of their device's benefits, and better monitor their competition. This can strengthen market position and increase confidence among healthcare providers, insurers, and patients.