Advanced Therapy Clinical Trials

Service Overview

Advanced Therapy Medicinal Products (ATMPs)

Advanced therapy medicinal products — including gene therapies, cell therapies, somatic cell therapies and tissue-engineered products — represent the frontier of modern medicine. These complex biologics require a clinical operations partner with deep scientific understanding, specialist site capabilities and rigorous quality systems. aCROss Medical is building dedicated ATMP trial expertise across our site network to support sponsors in this rapidly growing field.

Whether you are running a Phase I first-in-human gene therapy study, a Phase II cell therapy trial or a tissue engineering proof-of-concept study, our team provides the operational infrastructure, regulatory knowledge and investigator relationships needed to deliver these uniquely complex studies.

ATMP Trial Services

• Regulatory strategy for ATMPs across Georgian, Armenian, Israeli and Uzbek authorities
• Site qualification for ATMP handling — biosafety, chain of identity, chain of custody
• Investigator and site staff training for ATMP-specific procedures
• Cold chain and cryogenic logistics management
• Apheresis and cell collection logistics coordination
• Enhanced pharmacovigilance and safety reporting
• Long-term patient follow-up management (LTFU)
• Data management with eCRF systems adapted for ATMP complexity

Therapeutic Areas

Our ATMP trial capabilities span the key disease areas where advanced therapies are making the greatest clinical impact:

• Oncology — CAR-T cell therapies, TCR-engineered T cells, oncolytic viruses
• Rare genetic diseases — gene replacement and gene editing therapies
• Haematology — haematopoietic stem cell gene therapies
• Ophthalmology — retinal gene therapies and cell-based treatments
• Neurology — CNS gene therapies for neurodegenerative conditions
• Cardiovascular — cardiac cell therapies and vascular repair

Why Our Region for ATMPs

Israel is particularly well-positioned for ATMP clinical trials, with world-class haematology and oncology centres, extensive CAR-T cell therapy experience and a regulatory environment that supports innovation. Israeli academic medical centres have been involved in some of the most advanced ATMP trials globally, and their clinical teams bring unmatched experience in these complex procedures.

Georgia and Armenia offer cost-effective opportunities for later-phase ATMP studies, with growing specialist capabilities and strong government support for attracting innovative clinical research. aCROss Medical is actively developing ATMP site capabilities in these countries, working with leading academic partners to ensure that standards are met.

Quality and Compliance

ATMP trials are conducted under the strictest quality frameworks, including ICH E6(R2) GCP, applicable EU ATMP Regulation (EC No 1394/2007), and ISO standards for cell and gene therapy. aCROss Medical's quality management system is adapted to the specific requirements of ATMP studies, with enhanced oversight at every stage of the trial lifecycle.