HiRO - Harvest Integrated Research Organization’s Post

Trial oversight: Regulatory demands it, CROs try to deliver it, and sponsors gotta have it, but what tools and tech are required to actually achieve it? You need the right technology capable of delivering secure transparency in order to oversee the critical components of study management, including: -Study startup -Screening & enrollment -Document collection -Site visits -Monitoring reports -Subject visit completion -Action items and issue management, and more. Effectively plan, manage and track your clinical study portfolio with an optimal solution built to support sponsor oversight. Check out our white paper to learn more: https://lnkd.in/gG5ZAG3u #clinicaltrials #ctms #etmf #biotech #pharma

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

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

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 The recent draft guidance from the FDA on "Processes and Practices Applicable to Bioresearch Monitoring Inspections" highlights the critical role of Phase 1 CROs in ensuring data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

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

📝 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 

#ICYMI Be sure to watch Laxminarayan Bhat, Ph.D., Reviva CEO, on Unboxing Biotech with John Vandermosten of Zacks Investment Research discussing Reviva’s timelines in terms of topline data readouts, FDA interaction, and when we might see the second Phase III trial for brilaroxazine. Previously published in March 2023, you can watch the video here: https://lnkd.in/gpU5fEte To view more of our video content, please visit our Newsroom: https://lnkd.in/gtpMdKC5. #RVPH #nasdaq #biotechnology #biotech #pharmaceuticals #pharma #clinicalresearch #reviva #revivapharma #revivapharmaceuticals #brilaroxazine #schizophrenia #clinicaltrials

🌟 Exploring the significance of Clinical Trial Protocols in Drug Development: Discover why these documents are the backbone of successful trials, why it is mandated by the US FDA, and how they drive quality data.📜  Click the link to learn more about Clinical Trial Protocolos: https://lnkd.in/ddE8PGhK     #adiintellect #clinical #trial #protocol #importance #components #challenges #clinicalstudy #clinicalprotocols #regulatoryguidelines

WATCH NOW: Early stage development is critical for establishing a solid foundation for clinical trials. In this video, learn about the importance of early stage development for successful clinical trials and regulatory approvals, and why collaboration with experienced partners is essential. https://lnkd.in/gyvdxFHF

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