Design and Production of IMP Labels
CTSM offers GMP validated IMP (investigational medicinal product) label production. This enables CTSM to offer fast and efficient label production, as we have our own in-house printing facility.
Our highly experienced staff provides advice regarding general requirements to design and content of IMP labels in accordance with the EU GMP guidelines. When designing labels for a clinical trial, CTSM work closely together with the sponsor, ensuring a custom made fit for each study design with mininmal effort from the sponsor.
Your Benefits
- Reduced lead time on delivery of labels
- Label design customised to fit the requirements
- The right setup for the right study design
Sourcing of Packaging Materials
CTSM can assist in designing and sourcing of customised packaging materials and patient kits. When designing the packaging materials for a clinical trial, CTSM works proactively with the sponsor, facilitating the best custom made fit with minimum effort from the sponsor. This ensures optimal blinding solutions, so each package is designed and adapted for each individual product type and requirements according to the study design and visit schedule.
We provide materials of the same high quality and consistency throughout the productions. Furthermore, we ensure easy handling for site personnel and patients to induce compliance.
Your Benefits
- Optimally designed to the exact study
- Plug and play standard solutions developed through extensive experience in packing designs
- Proactive solutions to ease handling for site and patients
Secondary IMP Packaging
CTSM offers secondary packaging according to GMP as an integrated part of the clinical trial supply services. All packaging are performed in GMP validated facilities by trained and dedicated staff.
All secondary packaging tasks are performed with full batch documentation and QA control.
We ensure that the packaging design matches the study design, activities are dealt with in a timely manner and that changes in the process are documented and implemented efficiently.
We offer secondary packaging of IMP, just-in-time labelling, extension of expiry and fast track packaging. We are highly flexible and have the capacity to meet the demands of your packaging needs.
Your Benefits
- Meet your timelines with fast track packaging solution
- Packaging and repackaging of IMP in full compliance with EU GMP
- Dedicated project management to each trial
Just-in-time Labelling
As an additional option to the packaging and labelling activities, CTSM offers Just-In-Time (JIT) labelling in order to add details to the IMP just before distribution to site. In some regions JIT labelling is required by the national authority. Examples of JIT details added to an IMP label are site details, patient screening or identification no., and investigator details, right before shipment. CTSM has extensive experience in making the best JIT design, which can be quickly implemented in your specific clinical trial.
Your Benefits
- Making you IMP specific
IMP Storage
CTSM provides a GCP/GDP compliant storage area dedicated for clinical trial materials.
We offer ambient and cold storage of pharmaceuticals, inclusive cytostatics and controlled substances.
In most cases, storage of materials starts with import control, documented receipt and includes extensive surveillance, ongoing inventory status reports and full control and traceability over stock. You can easily follow the live data of the available IMP in stock through external login.
Within the restricted area there are separated locations for quarantine, storage and returned products.
Only trained and authorised personnel have access to the area, which is controlled by a comprehensive security program including monitoring, and security guards and security cards providing limited access.
Your Benefits
- Secured and separated storage
- Full control over stock
- Easy access to stock level data
Facts
- GCP/GDP compliance
- Flexible storage capacity
- 24/7 alarm reaction system
- Temperature and humidity monitoring