Services
Clinical Phase Formulations - Clinical Trials Services
Pharma Solutions launched their Clinical Trial Services (CTS) capabilities at the Morpeth, UK site in August 2008. CTS capabilities cover the investigational drug supply process from packaging through to patient kit returns and reconciliation.
Clinical Trial Services has primary and secondary packaging capabilities of over 13000 sq ft. The design of the facility is based on agility and process flexibility with an integral suite of re-configurable packaging booths.
CTS offer the following services:
- Strategy development & optimisation of clinical supply programmes
- Single and multi-project management
- Regulatory clinical trial application support and full supply-chain QP certification
- A real-time, fully integrated protocol tracking system, from project initiation Protocol inventory management to the patient kit level
- Drug medication sourcing
- State of the art Primary and Secondary component design
- Electronic bar-code verification of all critical assembly and distribution steps
- Labelling and assembly of vials, bottles, blister cards, and various other formats
- Complete portfolio of storage and global distribution capabilities including controlled drugs
- Post study drug returns, reconciliation and destruction management
Projects are monitored and controlled by a customised project management and tracking system known as TRAKPACK. The system is a fully integrated and validated GMP & Project Status tool which allows data interface with IVRS. It captures and gives client visibility to all project related activities throughout the entire lifecycle of a project, and its interface can be customised with the client’s branding.
For a demo of TRAKPACK click here.
Piramal Clinical Trial Services is a specialised unit operating within the broader Piramal Healthcare organisation. This means that CTS is closely aligned with complementary development units. Customers benefit from seamless coordination with other Piramal drug supply services, including formulation, pharmaceutical analysis and manufacturing. This enables customers to work with one efficient and flexible supplier across all activities and achieve significant savings on time, cost and supervision.