贺维斯特医药科技 HiRO

We’re proud to have Aimee on our team, contributing to our US operations with her extensive clinical research experience. With 8 years in global project management and 14 years monitoring phases I-III trials, she plays a significant role in our oncology, respiratory/pulmonary, and dermatology studies. Aimee's strengths in vendor management and cross-functional collaboration enhance our team's effectiveness as she works closely with medical monitors, data management, regulatory affairs, CRAs, pharmacovigilance, and medical writing. Additionally, she leads Safety Review and Trial Steering Committee meetings and provides mentorship to our US Clinical Trial Managers. We're excited to see how Aimee continues to drive positive change within our projects and the industry as a whole! #HiRO #HealthcareExpertise #ClinicalResearch #ClinicalOperations

We are excited to be at JSMO (Japanese Society of Medical Oncology) today! If you haven’t had the chance to meet us yet, be sure to stop by Booth #12 and say hello. ?? We look forward to sharing insights on how we can accelerate your upcoming oncology trials and help drive innovation in the field. Our team is eager to discuss potential collaboration opportunities and explore how our expertise can support your projects. Ya-Han Chang Dr Cristina K Chang Ryosuke Endo Tsukasa Kiriyama Alexander K. KAWASAKI Junghoon(Gerard) Kim #JSMO2025 #Oncology #JSMO #ClinicalTrials #HiRO

When it comes to MRCTs, each country has its own submission pathways, document requirements, and compliance standards, making the regulatory landscape challenging to manage. Find out more about these submissions here: https://buff.ly/41mnW5z #HiRO #MRCTs #ClinicalResearch

Join the HiRO team at the Japanese Society of Medical Oncology (JSMO) in Kobe, Japan, this week! ?? Visit us at Booth #12 in Exhibition Hall 3 to discover more about our global operations and our relentless pursuit of advancing oncology research through collaboration with our clients and partners. At HiRO, we take pride in our extensive experience in oncology trials, led by a dedicated team of experts with over 20 years in the field. We are committed to pushing the boundaries of cancer research and improving patient outcomes. We look forward to seeing you there! Ya-Han Chang Dr Cristina K Chang Ryosuke Endo Tsukasa Kiriyama Alexander K. KAWASAKI Junghoon(Gerard) Kim #JSMO2025 #Kobe #Oncology #MedicalOncology #HiRO

It is expected that 1 in 4 of us will be living with obesity by 2035. World Obesity Day is a unified day of action to raise awareness for the world’s growing obesity crisis. Find out more https://lnkd.in/dfFqqC7J Make sure to see how HiRO supported this Phase 2 Obesity trial - https://lnkd.in/gnATEQZ9 #WorldObesityDay #ObesityAwareness #HiRO

Navigating global clinical trial submissions is a complex and highly regulated process, requiring careful planning and strategic execution. To better understand global IND (Investigational New Drug), CTA (Clinical Trial Application), and CTN (Clinical Trial Notification) submissions, we’ve outlined key considerations for MRCT study start-up, document preparation, regulatory submission pathways, and lifecycle management.

Rare Disease Day is the globally-coordinated movement on rare diseases, working towards equity in social opportunity, healthcare, and access to diagnosis and therapies for people living with a rare disease. At HiRO, we remain committed to causes like this and supporting the development of life saving medicines. Find out more → https://lnkd.in/gk6hbAF

What an amazing week for our team! ?? This week, we had the privilege of hosting seminars in four cities: Tokyo, Seoul, Taipei, and Shanghai! Our dedicated teams from the US, Europe, and ANZ came together to share insights on harnessing the unique advantages of diverse regions for clinical trials. We were also honored to have VCs—VMS Group and abcIMPACT—join us, enriching our discussions with their invaluable perspectives on global fundraising trends and the outlook for our industry. ?? A heartfelt thank you to everyone who participated. Your engagement and enthusiasm truly elevated these conversations! We hope you found the information enlightening and inspiring. Cheers to our incredible global team for making this remarkable tour possible! Let’s continue to connect, collaborate, and drive innovation forward together! ?? #GlobalCollaboration #ClinicalTrials #Innovation #IndustryInsights #Networking

Unlike other special designations, RMAT has a unique requirement that the drug must be a specific type of advanced therapy product, which distinguishes it from other expedited development pathways. Keep reading about RMAT and its eligibility requirements https://lnkd.in/g4gJu4uE #HiRO #RMAT #AdvancedTherapy #RMAT #AdvancedTherapy #FDAApproval #TherapeuticInnovation

This innovative approach was put in place to address approval processes that can be extremely time-consuming, often requiring 5 to 10 years to demonstrate a drug's ultimate clinical benefit. Find out more about the Accelerated Approval Pathway’s eligibility criteria and benefits Read more https://lnkd.in/gsg6iW4D #AcceleratedApproval #DrugDevelopment #FDAApproval #ClinicalTrials #RegulatoryPathways