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Blog Posts (75)

  • Clinical Supply Logistics: A Key Pain Point for Biotech and Pharmaceutical companies

    The management of clinical supply logistics has emerged as a particular challenge for Contract Research Organizations (CROs) serving biotech and pharmaceutical clients. As clinical studies are becoming more complex and expensive, biotech’s are turning to CROs for full-service outsourcing, to unburden themselves of the complexities and costs of clinical trials. Amidst this collaboration, concerns persist regarding the satisfaction levels and the efficacy of supply delivery logistics. The logistical needs of biotech and pharmaceutical are multifaceted, encompassing the intricate coordination of timely and safe delivery of supplies, managing complex distribution networks, returns and destructions and complying with stringent regulatory requirements. These tasks become even more daunting for small biopharma companies, which often operate with limited resources and infrastructure. Biotech firms therefore rely heavily on CROs for such services however have expressed lower satisfaction levels with CROs compared to their established pharma counterparts. A survey conducted among 80 CRO customers, spanning both large pharma and biotech firms, sheds light on the disparity in satisfaction levels and in particular, dissatisfaction with logistical services. Across all 14 service areas assessed—ranging from study design and project management to lab services and supply logistics—respondents from both pharma and biotechs rated logistical services low and as a particular source of bottlenecks [1]. Key concerns voiced by CRO clients from qualitative interviews include the perceived lack of focus on C-suite needs, misalignment of incentives due to the fee-for-service model, and a limited differentiation among CROs in terms of services. These challenges underscore the need for CROs to reassess their approach and provide full-service, tailored solutions that address the unique requirements of biotech clients. Clinical Services International (CSI) brings strategic perspective to the table, providing efficient sourcing, distribution and waste management practices, resulting in substantial cost savings; a factor of paramount importance for resource-constrained biotech firms. For open label studies, CSI can deliver directly to sites in a fast, reliable and cost-effective manner. Moreover, CSI plays a crucial role in de-risking studies by implementing robust project management practices. By supporting CROs in establishing themselves as best-of-breed full-service "general contractors," CSI facilitates the seamless management of Investigational Medicinal Products (IMPs), comparator sourcing, packaging, labelling, combination therapy and ancillary services. As established pharmaceutical companies are resorting to bring these services in-house again following outsourcing frustrations, the value proposition of CROs to smaller biotech companies becomes ever more apparent. With the biotech market projected to grow significantly and exponentially, there exists a ripe opportunity for CROs to align their services with the unmet needs of this sector. In conclusion, clinical supply logistics stands as a critical pain point for CROs serving biotech clients. However, with the strategic integration of innovative solution providers such as CSI, CROs can not only mitigate these challenges but also emerge as indispensable partners in driving the success of clinical trials within the biopharmaceutical ecosystem. [1] Bleys J, Fleming E, Mirman H, The L, CROs and biotech companies: Fine-tuning the partnership. McKinsey & Company, Life Sciences Practice, June 2022. Source: McKinsey Customer Survey, May 2021

  • Visit CSI at Clinical Trial Supply Europe

    The CSI Team will be in Barcelona next month for Clinical Trial Supply Europe on 6th-7th March 2024. Visit Booth 42 to explore all of CSI’s capabilities in comparator drugs, co-medications, and ancillary clinical trial supplies.

  • Advancements in Oncology

    This month, we are focusing on Oncology and have reflected on the notable advancements to oncology medications in recent years. Immunotherapy: Immunotherapy has been a significant focus in oncology. Checkpoint inhibitors, such as pembrolizumab and nivolumab have shown success in treating various cancers by targeting specific proteins that inhibit the immune system's response to cancer cells. CSI has longstanding experience sourcing these immunotherapy drugs for over 100 studies. Targeted Therapies: Advances in understanding cancer genetics have led to the development of targeted therapies that aim to disrupt specific pathways involved in cancer growth. Drugs like imatinib and bevacizumab, which CSI have sourced for more that 35 studies, have been successful in treating cancers with specific genetic mutations. CSI has procured a wide range of these targeted therapy drugs for clinical studies worldwide. PARP Inhibitors: Poly ADP-ribose polymerase (PARP) inhibitors, such as olaparib and rucaparib have shown efficacy in treating certain types of cancers, particularly breast cancer with BRCA mutations. Their mode of action is interfering with DNA repair mechanisms in cancer cells. CSI possesses a strong track-record sourcing this medication. ADCs (Antibody-Drug Conjugates): ADCs are a type of targeted therapy that combines monoclonal antibodies with chemotherapy drugs. Trastuzumab emtansine (T-DM1) is an example used in breast cancer treatment and CSI has good access, finding sourcing solutions for over 50 studies. CAR-T Cell Therapy: Chimeric Antigen Receptor T-cell (CAR-T) therapy has shown promise, particularly in haematological malignancies. This personalized treatment involves modifying a patient's T cells to express a receptor that targets cancer cells. Adjuvant Therapies: Advances in adjuvant therapies, including post-surgical or post-chemotherapy treatments, have improved the outcomes for some cancer patients, reducing the risk of recurrence. Precision Medicine: The concept of tailoring cancer treatment based on individual patient characteristics, including gene sequencing and other biomarkers has gained prominence, leading to more personalized and effective treatment strategies. This personalised approach is the future of cancer diagnosis and treatment. CSI has comprehensive expertise in oncology, biologics and biosimilar products and has provided solutions to more than 1000 clinical trials all over the world, in studies developing the many types of oncology drugs explored in this article. To find out more about how CSI can support your clinical trial, go to our Case Study and Our Services page.

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  • Another great year for CSI and ICON’s partnership

    Another great year for CSI and ICON’s partnership Seven years of successfully supplying 100+ studies How Does CSI Support ICON? At CSI, we regard ICON as one of our most valued clients. Our collaboration started seven years ago, and since then, our partnership has grown from strength to strength. With CSI at your side, ICON can remain dedicated to its core mission of serving patients and conducting clinical trials, while we take on the responsibility of delivering medicines for your trials worldwide with precision and care. Our Partnership in Numbers Throughout the past seven years, we have assisted ICON with over 400 opportunities and over 100 purchase orders, delivering on quality and providing cost savings amounting to a third of your budget in 2023 alone. We are committed to supporting you, driven by our scientific expertise, industry experience, and exceptional relationships with manufacturers and audited suppliers. In 2023, we achieved together: Opportunities 170 CPAs 0 Escalations 0 66% Budget Saving Opportunities 170 CPAs 0 Escalations 0 Budget Savings 66% Our accomplishments include several noteworthy studies, for which we have analysed the protocol and not only provided excellent solutions, but also facilitated substantial cost and time savings. One example includes our advising the use of biosimilars instead of branded products, resulting in savings worth millions. Challenge To distribute ancillary devices for a client’s three-year COPD study, spanning 15 countries in EU, US and APAC. A central sourcing model was not appropriate due to import and export complications and the high VAT of the product. Solution We identified 15 new warehouses for the storage of the devices containing lithium batteries – auditing and qualifying them within a tight timeframe, since the GMP warehouses in our portfolio were limited to the storage of medication. Result We provided stock to all depots and sites across the world. CSI also managed returns, creating country-specific kits. Our flexible supply chain solutions enabled scheduled SIVs to proceed and for the study to commence without delay. Case study Planning Over the years, CSI has undergone significant growth, establishing a truly global presence with offices CSI expertise Cost Analysis Forecasting Supply Planning Read all Planning Sourcing Labelling services, have our own warehouses in the US and Germany, with a further 60 partner Comparator IMP Ancillaries Samples for analysis Read all Sourcing Manufacturing Provide ICON with a short and secure supply chain and all the required documentation Labelling Blinding Primary Packaging Secondary Packaging Read all Manufacturing Distributing Direct relationships with more than 90 pharmaceutical manufacturers worldwide Logistics Depots Shelf-life control Tracking shipments to sites Direct to Patient Read all Distributing EXPANDING OUR SERVICES - Our Global Reach Warehouses and offices Our network extends to 60 countries on six continents Countries CSI are supporting ICON studies’ Australia France Mexico South Africa Austria Germany Netherlands Spain Brazil Hungary Poland Taiwan Bulgaria Israel Romania United Kingdom Canada Italy Slovakia USA Egypt Japan Katja Schneegass Contact Stephan Mütze Contact Joanna Amoah Contact Your CSI designated Project Managers Case studies Export of expensive comparators from Europe to China with first leg documents and streamlined approach Read more CSI’s seamless comparator export to China How CSI’s flexible approach to global distribution ensured a large biotech’s three-year study across 15 countries could proceed without delay Read more Global Medical Device Distribution How CSI rescued an oncology trial when a competitor failed to deliver, despite an extremely tight deadline and scarce supply on the market Read more Rescuing a Global Biotech's Oncology Study with Cetuximab How CSI has saved a leading global pharmaceutical company €1 million by sourcing pembrolizumab from the market at the best possible price Read more Delivering €1 million Savings for Pembrolizumab How CSI supplied large quantities of ruxolitinib to a CRO’s ongoing Phase 3 oncology study involving 14 countries, nine depots and 67 site shipments Read more Global CRO Oncology Partnership How the flexibility and initiative of CSI’s Quality team overcame challenges to ensure timely product supply for a partner’s ongoing clinical trial Read more A Quality Solution to Clinical Trial Supply How CSI delivered mission impossible: sourcing specific tested batches of an expensive oncology product from several European markets Read more Oncology Product Batch Hunting How CSI used its scientific expertise at the protocol stage to provide flexibility in sourcing strategy and ensure high volumes of a single product were supplied on time to multiple countries Read more Delivering Comparators for a Global Allergy Study How CSI’s regulatory guidance and robust sourcing solutions ensured the success of a global flu vaccine trial that could not afford to run behind schedule Read more Sourcing Flu Vaccines for a Global Trial How CSI leveraged its vendor and warehouse networks to supply aflibercept for a leading CRO’s oncology study within a tight deadline Read more Rapid Oncology Study Supply How CSI’s scientific insight delivered an agile sourcing model and substantial cost savings for a listed biotechnology company’s global trial Read more Streamlining Biotechnology Supply Chains How CSI leveraged relationships with multiple manufacturers to urgently supply large quantities of a generic drug to a global Phase 3 trial Read more Overcoming Drug Shortages

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