Early-phase success doesn't happen by chance. It comes from aligning scientific, regulatory, operational, and clinical strategies from the very beginning.
In this exclusive eBook, hVIVO's drug development experts share practical insights from across the early development landscape, covering IND readiness, first-in-human studies, due diligence, PK/PD strategy, human challenge studies, data management, early proof-of-concept, and more.
Inside this eBook
This collection of expert articles explores some of the most important considerations facing sponsors today, including:
- Preparing for successful investor and partner due diligence
- Designing effective first-in-human programmes
- Avoiding common early-phase development pitfalls
- Building robust PK/PD strategies
- Leveraging biomarkers and biosignals for earlier decision-making
- Understanding the benefits of human challenge studies
- Integrating regulatory, clinical, laboratory, and data management expertise
- Using early clinical data to increase programme value and reduce uncertainty
Early decisions shape future success
This eBook brings together perspectives from hVIVO's experts across:
- Clinical Development
- Regulatory Affairs
- CMC
- Data Management
- PK/PD
- Early-Phase Clinical Operations
- Human Challenge Studies
- Cardiometabolic Research
- Infectious Disease Development
- Biometrics & Biostatistics
Gain real-world insights designed to help you make better decisions, faster.
Meet the Author
Leading this collection is Dr. Katsuhiro Mihara, Head of Clinical Development & Drug Development Consulting at hVIVO. Drawing on more than 25 years of experience in pharmaceutical and biotech development, Dr. Mihara has helped shape clinical and regulatory strategies across multiple therapeutic areas and has supported investors and sponsors through critical development and due diligence milestones. His expertise and perspective set the foundation for the practical insights shared throughout this eBook.
Our Accreditations
Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is an international ethical and scientific quality standard; for designing, conducting, recording and reporting trials. Ensuring participant safety prevails over the interests of science and society.
Human Tissue Authority (HTA)
hVIVO is accredited by the Human Tissue Authority (HTA), meaning that we have been recognized by the HTA as compliant with standards and regulations for the ethical and legal removal, storage, and use of human tissue. A HTA license is essential, as hVIVO handles human tissue for various research purposes.
Good Clinical Laboratory Practice (GCLP)
All clinical trials comply with GCP and/or GCP for Laboratories (GCLP) guidance. Human Challenge Agent-only clinical studies that do not involve IMP also comply with GCP/GCLP.
hVIVO is a UKAS accredited Testing Laboratory No. 27882
