Category Archives: Case Studies

Delivering Enormous Cost Savings by Providing Sourcing Options for Oncology Products

One of our clients was preparing to run a global study with an expensive oncology product. CSI provided 3 outstanding sourcing options:

  • – Sourcing directly from the manufacturer by leveraging our relationship and delivering products with a 4-month lead time.
  • – Sourcing from authorised wholesalers in a timely manner at a slightly lower price.
  • – Providing the Biosimilar product which is registered both in Europe and USA: CSI worked closely with the Biosimilar manufacturer and provided extensive meta-analysis as well as equivalency statements regarding the product.

Choosing the Biosimilar delivered €7 million cost savings to the budget of the study.

This was a remarkable achievement for CSI and our client. We demonstrated our scientific knowledge, expertise, ability to deliver novel solutions, and the fact that we provide Gold Standard Supply.

Delivering Comparators for an Allergy Study

CSI was asked to support a client trial for sourcing of grass pollen allergen tests. There were 2 main concerns:

  1. – No product was licensed in all countries where the trial was running
  2. – Quantities required were considerable and the Sponsor was worried about the availability of the required quantity in the timelines to support the trial

The licensing aspect was clarified since the allergy test products were referred to as equivalent in the literature, the composition was essentially the same and use of the unlicensed products is common in many markets.

For consistency of study results, it was preferred to use the same test across all patients, which meant centralised supply and use of a product (even if unlicensed in a specific country) was justified. This was the basis for submission of the selected products to the country Regulators.

CSI’s solution for the large quantity and the sponsor’s concern was to obtain direct access not from just one but from two independent Manufacturers who agreed to supply the trial.

When it came the time to order, one of the Manufacturers indeed could not support the volume due to production changes and we worked with the backup source. The study ran to schedule and the client was satisfied.

Overcome Shortages by leveraging Relationship with Manufacturer

CSI had an urgent request from a client (we specialise in these) to urgently deliver a generic product in large quantities for a new trial. This was originally overlooked and therefore the timelines were very tight and would not allow for on-demand production.

CSI reached out to all generic manufacturers of this product and conducted extensive research in 3 continents. In the meantime, we also undertook extensive literature review and working closely with the manufacturer, we provided equivalency statements for the products provided.

We were the only supplier to provide a solution and we delivered according to schedule.

Sourcing Flu Vaccines for a Global Study

CSI supported a very challenging request from a client for a Quadrivalent Flu Vaccine Study (Northern Hemisphere).

We are aware of the seasonal nature of this product, which means one single production per year (in the summer) with the combination of viruses predicted around April by the World Health Organisation (WHO) to be the dominant strains for that flu season.

The vaccine doses are typically booked well in advance (approximately in January) by customers and there is very little oversupply. When our client was ready to run the study, several USA manufacturers were already overbooked. This was a key factor in our recommendation between the available manufacturers: Sanofi and GSK.

The trial sponsor wanted to use the product from the same manufacturer in the USA and Europe.

USA manufacturers were already overbooked versus their production and would have been unable to supply the required quantities. CSI was able to demonstrate equivalency with the EU product and offered it in sufficient quantity. The trial also ran in Thailand and, due to difficulties with import, we were also able to offer the same product sourced locally.

With a flu vaccine trial, the cost of getting the sourcing wrong is punishing.

The Southern Hemisphere is a poor option to run a flu trial given the limited choice of countries and the fact that the flu season and circulating strains are much less defined in Southern Asia.

Given that supplies are only made once a year and quickly get booked, failing to secure the supplies means postponing the study by one full calendar year.

CSI provided scientific advice and guidance, regulatory information, and robust sourcing options to safeguard the study.

Delivering Devices to Sites in Russia, Ukraine, Belarus and Georgia

CSI was contacted by a client that urgently required medical devices to be delivered to Russia, Ukraine, Belarus, and Georgia for a large oncology trial.

These devices/markers were required during the patient screening visit. These devices are only applied to a very limited number of patients under a standard of care; however, due to the increased level of follow up required in the environment of the clinical trial, the devices were being applied to all patients. The client thought initially that the sites would be able to source themselves, but the quantities required were higher than the UK and Germany joint monthly number of units, and deliveries had to be arranged on demand to 100 sites.

The quantities were so large compared to normal demand that they placed strain on the manufacturer’s own production and supply chain capability.

CSI worked closely with the client’s medical team to identify options for products with the same characteristics as alternative/option B solutions.

From a combination of the main and secondary source, CSI adequately supplied the study and avoided delays to patient recruitment.

We ensured that all required documentation was in place for smooth import and distribution, forecasted demand, and developed a safety net stock level to respond to variable patient recruitment levels.

Sample Testing and Delivery of Same Batch Oncology Products with all Documentation

Our client requested us to secure large quantities of a high, in-demand oncology product in both strengths that the product is available.

The client wanted CSI to deliver samples to perform specific analytical testing; once the testing was performed and the results were satisfactory, the client requested CSI to deliver the stock of the same batches with all documentation available for exports.

There are several challenges here: first, stock availability. Due to our in-depth knowledge of the market, we only targeted specific countries.

Second challenge: the ability to supply a specific batch.

We leveraged our outstanding relationships with authorised wholesalers to hold a stock of this expensive drug while the testing was being carried out. CSI would purchase following confirmation from the client of satisfactory analytical testing or ask the supplier to rotate stock and try again with the next batch in case the analytical test was not satisfactory.

We delivered above expectations and our client could meet corporate objectives.

I am truly extremely pleased that CSI managed to achieve the purchasing and delivery milestones which one could say “Mission Impossible” considering the tight market situation and strict requirement to test a batch which lead to the needs to reserve stock for weeks. A very BIG THANK YOU to CSI team for going beyond. Without you, we would be at a loss and not able to achieve the FPI milestone.

Top 5 CRO.