Our Library

  • Case Study – Supplying Specific Tested Batches of Oncology Product from the Market April 20, 2020 - Request Client approached us with a very specific request to test samples of an expensive oncology product and then purchase the same batches that had passed the testing stage. This was a challenging request as it required visibility of batches currently on the market before purchasing. This is only possible in certain markets where product availability is moderate. Due to the nature of the trial the client was not willing to disclose trial details and required documentation (Certificate of analysis… Continue Reading
  • Case Study – Sourcing Flu Vaccines for a Global Study April 18, 2020 - Request CSI was approached to support a quadrivalent flu vaccine study running in multiple countries in the Northern Hemisphere. The sponsor also wanted to use the same product in the trial across all participating countries. Due to the seasonal nature of this vaccine, there is only one production run per year (in the Summer), manufacturers look at predictions from the WHO of what the dominant flu strain will be in the Winter and then produce vaccines accordingly. The vaccine doses… Continue Reading
  • Case Study – Delivering Comparators for an Allergy Study April 16, 2020 - Request 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 client wished to utilise the same product for all patients enrolled to ensure consistency in trial results. The client wished to… Continue Reading
  • Case Study – Overcome Shortages by leveraging Relationship with Manufacturer April 14, 2020 - Request CSI had an urgent request to supply a large quantity of a generic drug for an ongoing Phase 3 trial. These products were initially overlooked as it was assumed the sites would supply. When this turned out to not be feasible it was close to trial initiation date, so timelines were extremely tight to deliver and keep the trial on track. CSI Approach CSI carried out extensive research to determine what drugs were licensed in the participating countries that… Continue Reading
  • Case Study – Delivering Enormous Cost Savings by Providing Sourcing Options for Oncology Products. April 10, 2020 - Request A client approached us with a request for a large quantity of an expensive oncology product, documentation such as Certificate of Analysis (CoA) was required for import into several of the countries involved in the trial. CSI Approach Due to the high value of the product and the importance of choosing a suitable strategy for the trial and sponsor CSI decided to investigate a range of options with different advantages and disadvantages so that the client could decide what… Continue Reading
  • Case Study – Delivering Devices to Sites in Russia, Ukraine, Belarus and Georgia April 8, 2020 - Request 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… Continue Reading
  • Ensuring stability in uncertain times April 6, 2020 - These are unprecedented times, but the need for stable and consistent comparator sourcing remains as necessary as ever. So what does it take for both suppliers and sponsors to surmount these odds? What steps can be taken to identify and develop robust comparator sourcing solutions? The coronavirus outbreak has created new and significant challenges for comparator sourcing companies and clinical trial sponsors — how many of us had ‘global pandemic’ in our business. Continuity plans? Some governments, in countries such… Continue Reading
  • Webinar – Comparator Sourcing in Clinical Trials: Complexities and Bespoke Solutions April 2, 2020 - Register for a Webinar hosted by CSI on Comparator Sourcing in Clinical Trials with Dr. Vanessa Dekou: Comparator sourcing is a fast-growing industry in clinical trials that has doubled within the last five years. As most drug candidates are being studied against the existing standard of care (comparator), the need for secure and transparent sourcing of comparator drugs and non-investigational medicinal products (NIMPs) on a global scale is likely to rise significantly. However, this is a very complex process and… Continue Reading
  • Covid-19 Notice March 30, 2020 - CSI has been monitoring the global COVID-19 pandemic since its outbreak in China in early 2020. Using guidance from global and national health organisations, we have put a range of measures in place to protect the safety of our employees, to ensure the continuity of clinical trial supply and provide medicines to patients. We have a robust Business Continuity and Disaster Recovery Planning for Coronavirus Disease (COVID-19) With our employees, clients and suppliers in mind we have A proactive program… Continue Reading
  • Whitepaper – Oncology Trials Comparator Sourcing March 22, 2020 - Comparator Sourcing for Oncology Trials – Current Trends and How to Safeguard Trial Progress This is an exciting time for oncology trials, year on year record numbers of therapeutics are launched and the indications for many drugs on the market are increasing rapidly. Immunotherapies and next generation biotherapeutics are being approved for more tumour types and a growing percentage of the late stage oncology pipeline are targeted biologics. However, with growth comes increased risk. Trials are more complex than ever,… Continue Reading
  • Whitepaper – Role of Comparators in Clinical Trial Designs March 22, 2020 - Introduction The role of Comparators in Clinical Trials Drug development is a very complex, long and expensive process. Once a suitable molecule is identified then clinical trials are undertaken to establish the effect of an intervention. Treatment effects are efficiently isolated by controlling for bias and confounding and by minimizing variation. Key features of clinical trials that are used to meet this objective are randomization (possibly with stratification), adherence to intent-to-treat (ITT) principles, blinding, prospective evaluation, and use of a… Continue Reading