Hemex Expands Global Clinical Network Alliance to Strengthen End-to-End CRO Capabilities
核心洞察
Hemex AG (搜索) announced the expansion of its global footprint through a Clinical Network Alliance with international partners, combining specialized expertise in oncology, regulatory operations, digital health, and site management.
The alliance provides comprehensive access to international trial networks across the United States, Europe, and India, supported by over 130 experienced professionals and a Quality Assurance team with successful regulatory inspections from major authorities worldwide.
Key partners include Kitsa USA (搜索) with AI-driven platform capabilities, Shankus Hospitals (搜索) with 13 oncology centers managing over 33,000 outpatients annually, and specialized CROs offering bioavailability/bioequivalence studies and regulatory compliance services.
Hemex AG (搜索), a European Contract Research Organization (CRO), announced the expansion of its global footprint through a Clinical Network Alliance with trusted international partners. The alliance combines specialized expertise in oncology, regulatory operations, digital health, and site management under one collaborative framework, delivering comprehensive, end-to-end CRO solutions for pharmaceutical, biotech, and medtech companies worldwide.
Strategic Global Reach and Capabilities
With a strong foothold across the United States, Europe, and India, Hemex and its partners now provide clients with seamless access to global trial networks, regional expertise, and diverse patient populations. This strategic reach allows for faster recruitment, stronger regulatory alignment, and efficient cross-border execution.
"With this alliance, Hemex unites its agility with the vision and strength of leading global partners. Together, we are shaping the future of clinical development – delivering solutions that are not only faster and smarter, but transformative for patients worldwide," said Franziska Stemmler, CEO of Hemex.
The alliance comprises more than 130 seasoned experts and a proven Quality Assurance (QA) team with successful regulatory inspections from the FDA, EMA, MHRA, ANVISA, WHO, Health Canada, TGA, and other major authorities.
AI-Driven Innovation and Technology Integration
Kitsa USA (搜索) serves as an anchor collaborator, combining Hemex's CRO expertise with advanced AI capabilities to create an AI-first CRO model. This integration enables smarter, faster, and more adaptive trial execution through "Service-as-Software" offerings that are redefining how clinical trials are designed and executed.
"Our alliance with Hemex and its partners marks a pivotal step in advancing the Kitsa ecosystem. By combining our advanced AI-driven platform with the deep expertise of leading CROs, we have created our 'Service-as-Software' offerings, that are redefining how clinical trials are designed and executed," added Ajay Nyamati, Co-founder & CEO Kitsa USA (搜索).
Oncology Expertise and Patient Access
Shankus Hospitals (搜索), a leading oncology network in India with 13 hospitals, brings substantial patient recruitment capabilities to the alliance. The network's Outpatient Department manages over 33,000 patients annually, the Inpatient Department serves 12,000 patients, and more than 1,200 oncology procedures are performed each year.
"Through this partnership with Hemex, Shankus Hospitals (搜索) can extend its oncology expertise beyond our local patient population, supporting global trials and contributing to faster, more impactful cancer research," commented Dilip Chaudhary, Director of Shankus Hospitals, India.
Specialized Research Services
The alliance includes COD Research (搜索), a full-service CRO specializing in site management and regulatory compliance, offering global pharmacovigilance services and flexible engagement models tailored to sponsor needs. Additionally, Shankus Enem (搜索) contributes experience in over 150 Bioavailability/Bioequivalence (BA/BE) studies across therapeutic areas including anti-diabetics, antidepressants, antibiotics, NSAIDs, and oncology, with capabilities in multiple formulations and eCTD reporting.
Andreas Schulz, Founder and Managing Director of the Alliance, stated: "The alliance is more than a collaboration – it positions us to meet the demands of global sponsors while contributing to the bigger picture of advancing healthcare worldwide. By joining forces, we can efficiently deliver the scale, compliance, and agility needed to meet the growing complexity of clinical development."
Hemex, headquartered in the Basel region with offices in Germany, Benelux, and across three continents, specializes in multinational clinical trials. The company's services include clinical operations, regulatory support, quality assurance, BA/BE, PK, and Phase I studies, rapid patient recruitment, and imaging core lab services, along with strategic guidance in grant writing and fundraising.