From protocol development to regulatory approvals, we expedite the necessary steps, ensuring a prompt kickstart to your study and a smooth path towards impactful results. With meticulous planning and efficient execution, we provide the support and expertise needed for a successful beginning. Trust us to lay the foundation for your study’s success from the very start. Speak with our experts today to accelerate your next clinical trial. https://lnkd.in/gT4rV36W #ClinicalTrials #RapidStartUp #Biopharma #RegulatoryApprovals #HiRO #ResearchSolutions
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Experience counts in clinical trial management. Find out from our blog how HiRO ANZ’s historical performance and global capabilities play a pivotal role in successfully navigating the intricacies of new trials, especially in diverse regulatory landscapes. Discover the value of experience in clinical trials: https://lnkd.in/gXUY5Bsp #ClinicalExcellence #GlobalHealthcare #RegulatoryCompliance #Biopharma #ResearchAndDevelopment
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Bham Pharma's tips on writing better clinical trial protocols: ✒ To write better clinical trial protocols, focus on clarity, consistency, and compliance. ✒ Clearly define objectives, endpoints, and methodologies. Ensure alignment with regulatory guidelines and ethical standards. ✒ Include detailed instructions for the Investigators and consider patient safety at every step. Regularly review and update protocols based on emerging data and feedback. #BhamPharma #Regulatorymedicalwriting
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Every single time I talk to one of these writers, I learn something new. Their advice is geared towards regulatory submission specialists, but the core lessons will speak to all kinds of team leaders. Hope to see you there!
Join Kelly Kilibarda, Robin Johnson, PharmD, and Sara Symons for a free webinar on Tuesday, October 8th, at 11 a.m. EST, as they share tips for smoother clinical regulatory submissions. 💡 What you’ll learn: - Common challenges in document writing & submission - Practical solutions to improve your daily processes - Best practices for better team collaboration & communication 🔗 Register now! https://lnkd.in/evXP9kmY #regulatorysubmissions #clinicaltrials #pharma
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In Clinical Research, it is essential to ensure drug safety, efficacy, and the integrity of clinical data. Good Clinical Practice (GCP) audits are essential to... [keep reading] https://lnkd.in/d_W8cExU #blog #GCP
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How can you ensure your clinical development plan will set you up for success? https://lnkd.in/gCJmDswH Read these insights from Allucent regulatory experts (and previous FDA reviewers) to learn how. A clinical development plan (CDP) is a comprehensive document that presents a holistic strategy for developing an investigational product from preclinical testing to market authorization. In this blog, you will not only learn about the fundamentals of the CDP but also strategies to optimize your plan. Hear from the experts, Sugato De (VP, Regulatory Strategy, Head of Medtech), Joshua Taylor, PhD, RAC (Sr. Director, Regulatory Affairs), Lisa Sanders (Sr. Director, Regulatory Affairs), John McIntyre, PhD (Director, Clinical Strategy) #Allucent #BringNewTherapiesToLight #ClinicalDevelopment #Biotech #RegulatoryAffairs
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📝 Introducing our latest Regulatory Dashboard whitepaper titled “ACT NOW: EMA Urges Timely Submission for CTR Transition“. Read on as our Regulatory Affairs experts, Louise Bracewell, Małgorzata Michalik, and Lara Stevanato, explore the key considerations before transitioning. With the January 2025 deadline approaching, around 70% of ongoing clinical trials must transition from the Clinical Trial Directive to the Clinical Trial Regulation. Make use of the expedited procedure until October 16th and contact ERGOMED for expert guidance on regulatory transition. Benefit from our team's decades of experience in Regulatory Affairs for a smooth transition process. Download now: https://lnkd.in/d9AK7tCW #regulatorydashboard #CTRTransition #regulatory #clinicaltrials #biotechnology #pharmaceuticals #drugdevelopment #clinicalresearch
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At BioPharma Services Inc. we are committed to maintaining the highest standards of compliance and quality in our clinical trials. The recent draft guidance from the FDA on "Processes and Practices Applicable to Bioresearch Monitoring Inspections" highlights the critical role of Phase 1 CROs in ensuring data integrity and participant safety. 🔍 What does this mean for us? ✔️Enhanced Preparedness: We are ready for both announced and unannounced inspections, with robust records management and staff readiness. ✔️Best Practices Implementation: From pre-announcement communications to post-inspection follow-ups, we are dedicated to continuous improvement. ✔️Global Compliance: We adhere to international regulatory standards, ensuring consistency and reliability across all our operations. 🤝 What does this mean for our clients? ✔️Quality Assurance: Confidence that our data is accurate and reliable, having undergone rigorous FDA scrutiny. ✔️Ethical Standards: Assurance that we prioritize the rights, safety, and welfare of all trial participants. ✔️Transparency and Communication: Clear insights into inspection findings and our commitment to corrective actions. We believe that these practices not only reinforce our commitment to excellence but also provide our clients with the trust and confidence needed in their clinical trials. Speak with a drug development expert for your next project today: 🔗: https://hubs.li/Q02BTTXh0 Read the full guidance here: https://hubs.li/Q02BV7Br0 . . . #clinicalresearch #clinicalstudies #clinicaltrials #phase1 #cro #clinicaltrials #LifeSciences
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How can you ensure your clinical development plan will set you up for success? https://lnkd.in/gfmvezr7 Read these insights from Allucent regulatory experts (and previous FDA reviewer) to learn how. A clinical development plan (CDP) is a comprehensive document that presents a holistic strategy for developing an investigational product from preclinical testing to market authorization. In this blog, you will not only learn about the fundamentals of the CDP but also strategies to optimize your plan. Hear from the experts, Sugato De (VP, Regulatory Strategy, Head of Medtech), Joshua Taylor, PhD, RAC Taylor (Sr. Director, Regulatory Affairs), Lisa Sanders (Sr. Director, Regulatory Affairs), and John McIntyre, PhD McIntyre (Director, Clinical Strategy). (To access the full infographic shown in the picture, go to the blog link above.) #Allucent #BringNewTherapiesToLight #ClinicalDevelopment #Biotech #RegulatoryAffairs
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Today we shine the spotlight on Annemarie Ableitner-Kurz, Principal Consultant at NDA. Annemarie is dedicated to supporting drug developers with their nonclinical programs, helping them successfully navigate regulatory submissions. She ensures they are well-prepared for a smooth transition to first-in-human studies or later stages of clinical development. Her most rewarding moments are when promising therapies are approved to enter human clinical trials. Click the link below to discover how Annemarie supports drug developers to succeed. https://lnkd.in/e4bjvg6B #ndagroup #regulatoryaffairs #drugdevelopment
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When approaching a regulatory submission to the FDA, EMA, or other global health authorities, you need the right data-focused clinical research organization that will consistently produce cohesive, quality-focused, and scientifically accurate documents. This is MMS. Click the link below 👇 to read case studies, review whitepapers, and learn why sponsors say, 'From day one, we were impressed with the efficient and smart decisions brought forth by MMS to bring this drug to market.' More: https://hubs.li/Q02qg0TC0 Leave a comment on how you feel working with or for MMS!💬 #OneMMS #pharma #drugdevelopment
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