Global IMP Distribution

Getting the right clinical trial materials at the right site in the right time is crucial in order to succeed with a clinical trial.

CTSM order management includes receipt of order requests, preperation of documentation, pick & pack of the IMP and distribution with full traceability to sites around the world. After delivery, CTSM assures correct delivery and GDP compliance before the IMP (investigational medicinal product) is released for use at site through proactive site dialoque and support.

We have a well established courier network offering different transportation models. 

Your Benefits 

  • IMP on site at the right time with full documentation 
  • Flexible distribution solutions 
  • Proactive site dialogue and support 

Facts 

  • Global distribution for over 100 studies to more than 20 countries 
  • Broad courier network 
  • Full compliant to GDP
  • Full traceability 
     

Extension of IMP Expiry

For ongoing clinical trials CTSM can perform a fast, compliant and documented extension of IMP expiry date. We offer to perform this service for IMP on stock at Specific Pharma CTSM, as well as IMP stored on sites in Denmark or other EU countries.

Your Benefits 

  • Reduce IMP waste 
  • Flexible expiry extension solutions
     

Clinical Pass-Through

The free movement of goods within the European countries makes one central European warehouse an obvious choice for clinical trial in Europe.

The authorities in Denmark and some other countries in EU demands a documented import control of IMP to be performed by personnel trained to perform import.

CTSM offers Clinical Pass-Through, which includes a fast documented import control of your IMP followed by direct delivery to site personnel in Denmark. Furthermore, we ensure that the IMP will be stored within the required temperature intervals and cold chain will not be broken.

Your Benefits 

  • Easy handling for site personel 
  • Securing the right temperature for the IMP throughout the process 
     

Import and Export of Controlled Substances

CTSM handles both the import and export certificate forms for controlled substances. This service is primarily used by sponsors with no local warehouse facilities. Any import of controlled substances to Denmark must be handled by a company authorized by The Danish Medicines Agency.

CTSM is authorized to handle controlled substances, and we will on behalf of sponsor fill out the import and export certificate forms and ensure that the certificate is delivered to the Danish Medicines Agency after shipment. Furthermore, CTSM will help sponsors in making the correct annual reporting to the Danish Medicines Agency of controlled substances.

Your Benefits 

  • Easy import and export of controlled substances 
  • Full documentation and yearly reporting saves time and effort for sponsor 
  • Authorized by the Danish Medicines Agency 
  • Minimum work flow for sponsor 
     

Return & Destruction

Handling of returns and reconciliation are often a time consuming task for the involved parties. In CTSM we have designed a special concept for handling returns where the workload on CRAs and site personnel is minimised. Full traceability and secure accountability are obtained. We produce and provide the required materials for site handling, transport, storage and documented destruction. This includes SOP's and instructions for site personnel. Every step can be adjusted to meet specific sponsor demands.

Returned materials can be sent to destruction right after receipt or it can be stored at CTSM until destruction green light is provided by sponsor i.e. at the end of a study. A special warehouse area is dedicated to storage of returned clinical trial materials.

Destruction of both regular clinical trial materials and controlled drugs will be fully documented and handled in compliance with the regulatory demands.

Your Benefits 

  • Safe return handling for site and CRAs 
  • Fast and efficient drug reconciliation 
  • Ready to use return and destruction concept with easy handling for site personnel 

Facts 

  • Site instructions, materials, documents and courier booking provided by Specific Pharma
  • Full traceability 
  • Separated storage area for returns 
  • Simplified reconciliation 
  • Documented destruction 
  • Return kit prepared and packed by Specific Pharma