Library

Our Library

  • Biologics: it’s getting personal!Biologics September 22, 2020 - Biologics may not be the ‘new kid on the block’ anymore, but they are becoming very popular, with biologics accounting for a quarter of drugs in the late-stage development pipeline. What does all of this mean for the future of medicine, the supply chain and clinical trials? Vanessa Dekou, Managing Director at CSI, provides a whistle-stop overview. Small molecule drug development involves chemical synthesis following a reproducible, ‘recipe-book’ approach. Biologics, in contrast, are produced by a living host organism –… Continue Reading
  • How to identify and manage risks in clinical trial suppliesClinical trial supplies September 16, 2020 - Running a successful clinical trial relies heavily on the management of risks within the supply chain. Risk management is an essential part of clinical trials to ensure you can generate a clear return on investment without disruptions. It’s a complex process of identification and management depending on a number of factors that can impact the effectiveness of the trial. There is no one size fits all approach. Each clinical trial has its own complexities based on the comparator, data, stock… Continue Reading
  • The one question you should ask your comparator sourcing partnerComparator sourcing August 25, 2020 - How can you be sure that your comparator sourcing partner will provide you with the best available solution? How do you know that the company has a truly global reach? How do you know whether your partner could save you hundreds of thousands of pounds, or not? Vanessa Dekou, CEO at Clinical Services International, identifies the key element that can help you make the right choice for your clinical trial supplier. There are multiple articles, podcasts and the like on… Continue Reading
  • 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