Clinigen CTS - case examples

 
 
 
 
 
 
 
 
 
 

Click on the map to read examples:

 

Brazil

Clinigen CTS has sourced products locally and worked with sponsors to have drugs delivered (temperature-controlled) to ANVISA approved sites

Argentina

Clinigen CTS has sourced controlled drugs and exported them to other countries

China

Clinigen CTS has purchased drugs, working with the SFDA to obtain export permits and successfully shipping products to sites in the USA

South Africa

We have purchased drugs and assisted with QP release for use in EU-based trials

India

Clinigen CTS has experience of sourcing products direct from manufacturers and approved distributors. We have also advised clients moving manufacture from Israel to India

Thailand

We have arranged drug supply and shipped to Singapore for packaging, and then shipped from Singapore to local trial sites

Examples of solutions in emerging markets

 
 
 
 
 
 

Examples of global single-sourcing solutions

Sourcing a brand in shortage
  • A client required a particular brand of UK drug for an ongoing study, but when it needed resupplying, there was a massive shortage of the drug
  • Clinigen CTS contacted the manufacturer and negotiated supply of drug already destined for the UK in bulk packaging. The bulk drug was shipped to
    the UK, QP released and transported to Clinigen CTS
  • Clinigen CTS obtained all necessary supporting documentation and extended stability data to ship the product to the United States for this global trial.
    We met the client’s timelines and saved time and major expense due to their not having to de-blister product
Upfront advice on cost and long-term supply options

Eloxatin® – Clinigen CTS was working on long-term supply of this product and were able to manage supplies through the transition from lyophilized powder to liquid formulation

Various generics – we have been able to source the same license number (thus exactly the same product) from different generics houses to cover increased requirements or during massive shortages

Humira®/Enbrel® – Clinigen CTS was able to advise clients on the best drug option from a shortlist to be used as a comparator. This could be for reasons of overall cost, availability, or, in this case – something as specific as the ease of manufacturing a matching placebo