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Only two days remain to take advantage of early bird registration for RECON 2025! 𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐭𝐨𝐝𝐚𝐲!🎉 ➡ https://lnkd.in/gE6WZtuj Why attend? 1. Discover cutting-edge internal and external R&D intelligence techniques driving successful drug development. 2. Learn from real-world examples of transformative industry breakthroughs. 3. Connect with like-minded professionals, expand your network, and engage in meaningful discussions. 🔎 Explore the Agenda: https://lnkd.in/girYwv7j Our speaker lineup includes luminaries from the FDA, industry leaders, and academia. Over the course of the two-day conference, we will delve into: 1. 𝐁𝐢𝐨𝐦𝐚𝐫𝐤𝐞𝐫 𝐭𝐨 𝐄𝐧𝐝𝐩𝐨𝐢𝐧𝐭 𝐓𝐫𝐚𝐧𝐬𝐥𝐚𝐭𝐢𝐨𝐧 - Establishing surrogate endpoints. 2. 𝐆𝐥𝐨𝐛𝐚𝐥 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐇𝐚𝐫𝐦𝐨𝐧𝐢𝐳𝐚𝐭𝐢𝐨𝐧 - Towards a streamlined global regulatory assessment. 3. 𝐏𝐫𝐨𝐣𝐞𝐜𝐭 𝐎𝐩𝐭𝐢𝐦𝐮𝐬 - R&D strategies, practicality, and collaboration between FDA and sponsors. 4. 𝐃𝐢𝐯𝐞𝐫𝐬𝐢𝐭𝐲 𝐢𝐧 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬 - Strategies and implications for enhancing clinical trial diversity. Spread the word among your colleagues- we can't wait to welcome you all there! #RECON #UniversityOfMarylandBaltimore #DrugDevelopment #Pharma #BioTech #FDA #ProjectOptimus #ClinicalTrials #RegulatoryStrategy #Biomarkers #Endpoints #RegulatoryHarmonization #VivproCorp #MorePowerToYou

Pharma companies are using lab data to reach patients faster and more effectively. https://ow.ly/AxvJ30sIA5M. Dr. Madeline Naylor, DHSc, MSc, ACRP-CP, Vice President of Health Informatics, RWD at Norstella, writes about how lab data is being used across the product lifecycle, from drug development to patient monitoring. Learn how NorstellaLinQ fills in the gaps associated with typical real-world data assets, enabling a 360-degree view of the patient journey. Click the link in this post to read the article. #Pipeline2Patient #FollowNorstella #Pharma #LabData #PatientJourney #ClinicalResearch

Pharma companies are using lab data to reach patients faster and more effectively. https://ow.ly/6VBc50Um84h. Dr. Madeline Naylor, DHSc, MSc, ACRP-CP, Vice President of Health Informatics, RWD at Norstella, writes about how lab data is being used across the product lifecycle, from drug development to patient monitoring. Learn how NorstellaLinQ fills in the gaps associated with typical real-world data assets, enabling a 360-degree view of the patient journey. Click the link in this post to read the article. #Pipeline2Patient #FollowNorstella #Pharma #LabData #PatientJourney #ClinicalResearch

Diversity in Clinical Trials. The FDA’s Diversity Action Plan (DAP) guidelines are a step toward more inclusive, representative clinical trials. By addressing recruitment barriers, building community trust, and engaging diverse populations, sponsors can generate more meaningful data and deliver equitable healthcare outcomes. At ACORN IQ, we help Pharma, Biotech, and CROs design DAP strategies, audits, culturally sensitive outreach-targeting, and continuous measurement. Contact us to learn how we can support your goals! #DiversityInResearch #ClinicalTrials #InclusionMatters #ACORNIQ #PatientEngagement #FDA #Pharma #Biotech #CEN Connect with us today: info@acorniq.co

𝗨𝗻𝘃𝗲𝗶𝗹𝗶𝗻𝗴 𝘁𝗵𝗲 𝗙𝗗𝗔 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗳𝗼𝗿 𝗦𝗲𝗰𝘁𝗶𝗼𝗻 𝟱𝟬𝟱(𝗯)(𝟮) 𝗔𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 This Friday, Khushee delivered a thought-provoking session as part of our Knowledge Nudge series on 𝗙𝗗𝗔 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝘀 𝗳𝗼𝗿 𝗦𝗲𝗰𝘁𝗶𝗼𝗻 𝟱𝟬𝟱(𝗯)(𝟮) applications. From breaking down the stepwise processes and requirements to exploring the benefits and challenges of this unique pathway, the session offered a fresh perspective on how 505(b)(2) accelerates drug approvals while maintaining rigorous standards.   She also delved into comparisons across pathways—𝟱𝟬𝟱(𝗯)(𝟭), 𝟱𝟬𝟱(𝗯)(𝟮), 𝗮𝗻𝗱 𝟱𝟬𝟱(𝗷)—shedding light on how 𝟱𝟬𝟱(𝗯)(𝟮) strikes the perfect balance between innovation and efficiency. The discussion not only clarified regulatory nuances but also reinforced the value of strategic foresight in clinical research.   𝗦𝘁𝗮𝘆 𝘁𝘂𝗻𝗲𝗱 𝗳𝗼𝗿 𝗺𝗼𝗿𝗲 𝗸𝗻𝗼𝘄𝗹𝗲𝗱𝗴𝗲-𝗽𝗮𝗰𝗸𝗲𝗱 𝘀𝗲𝘀𝘀𝗶𝗼𝗻𝘀 𝗲𝘃𝗲𝗿𝘆 𝗦𝗮𝘁𝘂𝗿𝗱𝗮𝘆! 📚 #FDAInsights #505b2Pathway #ClinicalResearch #DrugDevelopment #RegulatoryAffairs #HealthcareInnovation #ContinuousLearning #BioDev

🌟 From preclinical to post-market: Veristat delivers excellence at every phase. Whether it’s overcoming hurdles in the preclinical phase, navigating the complexities of clinical research, or ensuring smooth regulatory submissions and post-marketing support, Veristat is your trusted partner for full-service clinical research. 💬 Don’t just take our word for it: "I am grateful for the dedication, excitement, and clinical trial expertise that the Veristat team provided for our program. Veristat's collaboration was critical to the successful clinical trials that led to our product's approval."  – President of Research and Development, Mid-size Pharma 👉 Swipe below to learn how we ensure your program's success at every step. #ClinicalResearch #DrugDevelopment #HealthcareInnovation #ClinicalTrialManagement #PatientSafety #Veristat

Drug pooling has long been a topic of conversation among clinical supply managers. While use of drug pooling is far less common today than it was over a decade ago, our co-founder and Senior Director of Customer Solutions, Marc Lisi, shares how it can still be helpful in making today's trials more efficient. With clinical trial design getting more and more complex, time pressures to deliver on these trials continually increasing, and sponsors looking to save costs wherever possible, drug pooling can prove to be extremely beneficial in specific situations. Learn more at https://lnkd.in/eGiRswmS #Suvoda #clinicaltrials #clinicalresearch #drugpooling #healthtech

🔷Navigating the Journey of Clinical Trials: From Safety to Public Access 👉The path of a clinical trial is rigorous, methodical, and essential for bringing safe and effective treatments to the public. 🔍 Phase 1: Focuses on safety and understanding how the body processes the treatment. Involves 10-20 healthy participants over a month. 🔍 Phase 2: Expands to 50-75 participants and tests safety, effectiveness, and optimal dosage over a period of 3-12 months. 🔍 Phase 3: With 100-300 participants, this phase examines long-term safety and efficacy, evaluating if benefits outweigh risks over 6-12 months. 📜 FDA Approval: After successful trials, the application undergoes a 6-12 month review. Once approved, the treatment becomes accessible to the public. 🔍 Phase 4: Post-approval, this phase monitors rare side effects and compares cost-effectiveness with similar treatments over 3-12 months, involving 100-300 participants. #ClinicalTrials #ResearchAndDevelopment #Biotechnology #DrugDevelopment #HealthcareInnovation #MedicalResearch #Pharma

The evolution of new technologies has transformed how journal performance is evaluated 📈🎯 🔗 https://ow.ly/PFyc50ThcLb This transformation provides a great opportunity for publication teams within medical affairs and pharma to shift away from conventional citation-based metrics. Instead, they can delve into alternative impact metrics that better reflect the various facets of contemporary research dissemination and engagement. 🔎 Explore the effective utilization of the newest impact metrics for journal selection by checking out our recently launched whitepaper 🔗 https://ow.ly/PFyc50ThcLb #MedAffairs #Pharma #PharmaResearch #PharmaJournals #ImpactMetrics #JournalSelection