HiRO - Harvest Integrated Research Organization’s Post

Mastering the complexities of global clinical trials requires precise expertise and a strategic approach. At HiRO, we provide tailored solutions that span the entire drug development lifecycle—from discovery through to patient delivery. Our global experience, combined with profound local knowledge, empowers our clients to navigate regulatory landscapes confidently and achieve successful market entries. Discover how our dedicated partnership can transform your clinical development strategy. https://lnkd.in/dCpvXC7A #GlobalTrials #DrugDevelopment #ClinicalSuccess

Industry-changing drug pricing regulations were in the spotlight at Informa Connect Life Sciences' MDRP Summit in Chicago last month. From IRA implementation to an invigorated government approach to drug pricing, esteemed experts guided attendees through a dynamic and complex drug pricing landscape. Kalderos was there to listen and contribute every step of the way — check out our blog to see MDRP Summit’s biggest themes and takeaways. https://lnkd.in/gRhM27Eb #MDRPSummit

Next-generation therapeutics (NGTs) or #advancedtherapymedicinalproducts (ATMPs) are constantly growing in relevance. Patheon has nicely summarized tips on how to deal with according regulatory aspects. Find out more about the approach for mastering next-generation therapeutics in the Porsche Consulting Strategy Paper “Pharma’s transformation towards next-generation therapeutics”: https://lnkd.in/eeUTebZq #Pharma #NGT #NextGenerationTherapeutics #CellAndGeneTherapy

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

🌟 Just one week to go: DIA Core Singapore Annual Meeting 2024 🌟 🗓️ Save the Date: July 16, 17 2024 📍 Location: Singapore This event promises to be a cornerstone for professionals in the healthcare, pharmaceutical, and regulatory sectors. Whether you're looking to network with industry leaders, gain insights into the latest innovations, or contribute to pivotal discussions shaping the future of healthcare, DIA Core Singapore 2024 is the place to be. The program committee put together a comprehensive program from keynote addresses by industry pioneers to interactive workshops and panel discussions, the program promises to be insightful and forward-thinking. Finny Liu Sannie SF Chong Jack Wong 🚀(Asia Regulatory Professionals Association) Martin Lim Senthil Sockalingam Innovative Sessions: Engage with thought-provoking sessions on regulatory updates, clinical trials, patient engagement, and more. Networking Opportunities: Connect with peers, mentors, and potential collaborators from around the globe. Expert Speakers: Learn from Health Authority representatives and industry experts. Don't miss out on this exceptional opportunity to be part of the conversation shaping the future of Healthcare in Asia.🌍💡 #HealthcareInnovation #Pharmaceuticals #RegulatoryAffairs #DIA2024 #SingaporeEvents https://lnkd.in/evWxxptc

As a biotech, it can be difficult to raise the capital needed to perform your first clinical trial. But without a trial, you don’t have the data to submit to the FDA, and therefore can’t launch your product. Running a trial requires you to cashflow your firm for 12-24 months - and that’s just to see the study through. Then add the lack of clinical data on your product, and the complexity increases again, tenfold. On top of all that, you’re also accountable to your shareholders and need to give them progress reports on a regular basis. Oh, and you’re competing with large biotech firms who have (seemingly) unlimited funding to work with a well-known US-based CRO. So, what options do you have? In this longform article we deep dive into the challenges US biotechs are facing and some potential solutions we suggest: https://lnkd.in/gkPeXQbh

In her latest Forbes article, Eileen Faucher explains the business case for expanding diversity in clinical trials. At BTH, we have developed methodologies to gain insights into best practices in this regard. Reach out to learn how better patient representation in clinical trials can be a lever of sustained competitive advantage. Eileen@brasstackshealth.com #competitiveintelligence #forbes #healthequity #clinicaltrialdiversity

In case you missed it, our recent webinar unpacked the pivotal role of RTSM in ensuring seamless supply continuity and its profound impact on the success of clinical trials, especially within intricate protocols and ever-evolving resupply demands. In this webinar, hear from Johnson & Johnson Innovative Medicine's Tom DeLiso and 4G Clinical's Siobhan McKenna-Power, Benjamin Etschmann, and Kathleen Greenough as they discuss the paramount importance of experience in handling complex protocol designs, aligning with the study team and site expectations, and embracing best standard practices for successful clinical trials. View the webinar recording here: https://bit.ly/3uWCPP8 #4GClinical #clinicaltrials #pharma #biotech #RTSM #IRT

To learn more about it, visit: https://lnkd.in/d6rQTS5E #MedicalResearch #ClinicalResearchinPakistan #Clinicaltrials #RealWorldData #FullServiceCRO #CROPakistan #MetricsResearch #ResearchInnovationExcellence

When it comes to rare and orphan drugs, clinical trial data is typically quite challenging to acquire for a number of reasons. Observational studies, such as PASS, can be a valuable means through which to gather real-world data on your product’s performance. They can: -> improve our understanding of a drug’s safety profile -> support informed decision-making from healthcare professionals and regulatory agencies. But how to run PASS and observational studies in the complex makeup of the European market? Learn tips and tricks on how to get started in our latest article: https://lnkd.in/eJ2Pd4US #PASS #RareDiseases #OrphanDrugs #MarketAccess