Product Forecast and Design of Shipment Setup
CTSM provides product forecast to assist you in streamlining and optimising the supply chain, giving you the best opportunity to be proactive, ensuring a balance between availability of IMP at all times and minimising unnecessary product waste.
Ever increasing complexity of trial design calls for carefully planned and customised solutions when setting up a logistical supply chain strategy. Based on our vast experience we offer customised setup for each trial providing an expert supply chain strategy.
Early involvement of CTSM enables you to streamline your production line, minimise waste and ensure an optimised supply chain during the entire trial.
Your Benefits
- Balancing IMP availability and minimizing product waste
- Reducing cost by minimal waste of IMP
- Streamlined and optimised supply chain
Ongoing Site Shipment
CTSM continously assists our clients with resupply of IMP throughout the trial. Changes in sites and countries during the trial lifetime can quickly be adapted by CTSM. This means that any site or country can easily be added or removed from the distribution setup. If a demand for further IMP occurs, CTSM has fast and easy acces to pack and ship resupplies.
Your Benefits
- Quick adaptation of changes in no. of sites and countries
- Fast track packaging
- Delivery of resupplies throughout the study to meet recruitment rate
Clinical Trial Supply Consultancy
CTSM offers flexible consultancy solutions that fit into your short and long term needs. Our experienced staff will add specialised knowledge to your team, release internal resources, and will contribute and take over the responsibility for your clinical trial supply activities almost immediately.
Your Benefits
- Flexible consultancy
- High experienced staff
- Release internal resources
- Access to specialised knowledge
- Quick start up service
Packaging design
CTSM can proactively advice you on which packaging design would be preferable for your study. The design will be aligned to visit schedules that are outlined in the protocol.
We use our extensive knowlegde to guide you on how a product should be packed with the patient and site personnel in mind. Each packaging unit should be easy to handle for site personnel and patients while maintaining blinding and traceability, and packed to fit the requirements in the product supply strategy. We have the ability to quickly adjust the setup during the trial, should the need arise.
Your Benefits
- Customised packaging design
- Ensuring blinding throughout the process
- Providing full traceability
- Adjustable setup during the trial
Design of Randomisation
Randomisation in clinical trials can be handled either manually or through an IWRS system. CTSM can help you decide which approach is optimal for your specific trial.
Bigger trials will often require an IWRS system. Our team will support you in configuring and validating the IWRS system. Based on your input and ideas we help you build the most efficient system for your trial in close collaboration with the IWRS vendor. This means reduced time and effort for you as a sponsor, as our team has extensive experience in various systems from different IWRS vendors.
Manual Randomisation will be a good choice for the smaller studies. Besides achieving a significant cost reduction compared to an IWRS system, it increases the flexibility throughout the lifetime of the clinical trial. CTSM ensures that site staff can access the randomisation numbers in an easy, blinded and secure way.
Your Benefits
- Efficient and flexible setup or randomisation
- Extensive knowledge and experience within out team
- Minimal workload for sponsor when IWRS configuration is handled by is
Allocation & Randomisation
For manual randomisation setups CTSM acts as central call center; setting up, coordinating and handing out randomised blinded treatment for subjects in clinical trials throughout the entire study. Site staff can access randomisation numbers in an easy, blinded and secure way, so each subject gets randomised to their intended treatment.
The allocated IMP will be sent to the site together with code break envelopes, which is packed by CTSM. Additionally, CTSM offers to allocate the blinded trial product to each of the subjects, calculating trial product forecast and overseeing that all sites have sufficient products for incoming visits throughout the study lifetime. Setup of trigger level, minimum and maximum buffer and resupply weeks will be agreed with sponsor before initial IMP is shipped to site.
Your Benefits
- Minimum efford for site personnel
- Secure and fast manual randomisation within one hour
- Proactively monitoring stock levels at site
Sourcing of Comparators and Add-on Medication
Due to CTSM being part of Europe's leading pharmaceutical wholesaler, PHOENIX group, we are able to offer efficient sourcing of comparators, add-on medications and other products for clinical trials.
Through our extensive network of pharmaceutical manufacturers we offer single batch sourcing of pharmaceuticals at the right time, expiry, quantity, with the required certificates and at a competitive price. Furthermore, we can provide rescue or add on medication to your study from our own pharmaceutical wholesaler.
This service is of course an integrated part of CTSM services and with one point of contact for your clinical trial supply activities.
Your Benefits
- One point of contact for your supply activities
- Easy accss to comparators and add-on medication
- Using our extensive network to archieve competetive prices