CDMO and CRO
CDMO and CRO
Established in 2002 as a stem cell bank, CryoCord group has since evolved to become one of the most comprehensive human cell-based service provider in the South-East Asia. CryoCord’s cGMP facility is certified to PIC/S standard and together with 5 years of clinical trial management behind Cytopeutics (a subsidiary of CryoCord), the group is now actively looking for partners who are interested in human trials within the South-East Asia. CryoCord group is currently taking on jobs from pilot studies to various stages of clinical trials including but not limited to regulatory approvals, product development, trial design and CRO activities. You can be assured that our tenacity towards Quality and Efficiency has always been our principle. Given a big population size of more than 600 million and vast ethnic diversity in the South-East Asia, a well planned clinical trial can give you the safety and efficacy assurance which you are looking for.
CDMO:
- cGMP manufacturing
- Regulatory Support and Service
- Assay/ Analytical Development
- Provide wide range of testing services for cell based product
- Quality Assurance and Quality Control Development
- Quality Control Testing
- Product Development Service (both Allogeneic and Autologous)
- Process validation from design, manufacturing to implementation
- Personalised to large-scale cGMP-compliance production of cells for case studies, clinical trials and commercial application for approved products
- Storage and distribution of cell-based products
- Assist in funding
CRO:
- Investor recruitment / assist in grant application
- Assist in protocol design and writing
- Sample size calculation
- Randomization
- Preparation and submission for ethics approval (EC/IRB) / regulatory approval
- Project Management
- Site Management
- Clinical Data Management
- Investigator Recruitment
- Patient Recruitment
- Safety Data Management
- Statistical Analysis
- Archiving
- Registry
- Partnership with Universities and Medical Centres
- Comply to Personal Data Protection Act (PDPA) 2010.
