Harvest Integrated Research Organization
HiRO is a globally oriented, innovative boutique CRO dedicated to elevating cross-border clinical trial pathways. It collaborates closely with biotech and pharmaceutical companies to efficiently bridge laboratory research and market commercialization, providing cutting-edge, capital-efficient solutions to benefit patients worldwide. The organization emphasizes tailored solutions, extensive global experience, local knowledge, and a people-centered approach to clinical research, aiming to support scientific breakthroughs and accelerate the delivery of new treatments.
Industries
Nr. of Employees
large (251-1000)
Harvest Integrated Research Organization
Excelsior, Minnesota, United States, North America
Services
Regional and international project management, portfolio strategy, study planning, timeline management, and CRO oversight for end-to-end clinical development.
Regulatory consultation, preparation and submission support for clinical trial applications and marketing authorisations, CMC and non-clinical regulatory planning.
Medical monitoring, medical writing, KOL engagement, protocol and development planning, and advisory support for regulatory meetings.
Feasibility assessments, site selection and management, clinical monitoring, and site relationship management to support trial conduct.
Clinical data management, statistical analysis, programming, data visualisation, and process automation to support study design and reporting.
QMS establishment, SOP gap analysis, GCP training, risk-based quality management, and clinical trial auditing.
Regional and international project management, portfolio strategy, study planning, timeline management, and CRO oversight for end-to-end clinical development.
Regulatory consultation, preparation and submission support for clinical trial applications and marketing authorisations, CMC and non-clinical regulatory planning.
Medical monitoring, medical writing, KOL engagement, protocol and development planning, and advisory support for regulatory meetings.
Feasibility assessments, site selection and management, clinical monitoring, and site relationship management to support trial conduct.
Clinical data management, statistical analysis, programming, data visualisation, and process automation to support study design and reporting.
QMS establishment, SOP gap analysis, GCP training, risk-based quality management, and clinical trial auditing.
Expertise Areas
- Clinical trial management
- Regulatory strategy and submissions
- Pharmacovigilance and safety
- Biostatistics and clinical data management
Key Technologies
- Electronic data capture (EDC) systems
- Statistical programming (e.g., SAS/R)
- Biostatistics and statistical modelling
- Machine learning for medical imaging
News & Updates
Harvest Integrated Research Organization (HiRO), an innovation global CRO, has acquired Courante Oncology, a US-based full-service clinical research provider specializing in oncology product development. This strategic move extends HiRO’s presence into the US market and enhances its capabilities in managing global studies.
The biotech funding environment has undergone significant changes, with investment levels falling and more competition for funds, making capital investment more challenging. Biotech companies need to design cost-effective clinical trials and position themselves attractively to investors.
HiRO successfully raised tens of millions of US dollars in Series A financing, marking a significant milestone in its growth and expansion.
Harvest Integrated Research Organization (HiRO), an innovation global CRO, has acquired Courante Oncology, a US-based full-service clinical research provider specializing in oncology product development. This strategic move extends HiRO’s presence into the US market and enhances its capabilities in managing global studies.
The biotech funding environment has undergone significant changes, with investment levels falling and more competition for funds, making capital investment more challenging. Biotech companies need to design cost-effective clinical trials and position themselves attractively to investors.
HiRO successfully raised tens of millions of US dollars in Series A financing, marking a significant milestone in its growth and expansion.