CSI is extremely proud to announce our Platinum EcoVadis Award, signifying the highest level of recognition for corporate sustainability performance. This prestigious certificate is awarded to companies that demonstrate outstanding sustainability practices across environmental, social, and ethical governance. Achieving the Ecovadis Platinum award confirms that CSI has excelled in sustainability performance evaluation, surpassing industry standards. This award reflects our commitment to sustainable business practices and responsible corporate citizenship. Contact CSI, your platinum clinical trial supply partner.

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

CSI is attending GCSG US in Naples, Florida on 21st-24th April at the Hyatt Regency Coconut Point Resort and Spa. Visit Booth 4 to speak to our Managing Director, Vanessa Dekou and Director of Strategy, Andrea Giochetta.

Ancillaries play a crucial role in ensuring the smooth execution of clinical trials, encompassing a broad range of items, materials and services beyond the investigational product itself. From medical and wearable devices and diagnostic tools to specialized equipment, ancillaries are indispensable components of the clinical trial supply chain. What are Ancillaries? Ancillaries refer to any supplementary items or services required for the proper functioning of a clinical trial beyond the primary investigational product. These can include: Medical Devices: Such as infusion pumps, wearable sensors, or monitoring devices necessary for patient care and data collection. Diagnostic Tools: Including imaging modalities, laboratory assays and diagnostic kits utilised for patient assessment and disease monitoring. Clinical Supplies: Such as bandages, swabs, and other medical consumables, simple but essential for trial procedures. The Importance of Ancillaries in Clinical Trials Ancillaries are integral to the successful execution of clinical trials for several reasons: Patient Safety: Many ancillaries directly contribute to patient safety during the trial by providing essential medical care and monitoring. Data Quality: Ancillaries often facilitate data collection, allowing researchers to gather accurate and reliable information crucial for evaluating the safety and efficacy of investigational products. Regulatory Compliance: Compliance with regulatory requirements is paramount in clinical research and ancillaries often play a key role in meeting these standards through proper documentation and adherence to guidelines. Sourcing Ancillaries for Clinical Trials Clinical Services International (CSI) offers comprehensive solutions for sourcing ancillaries alongside comparator drug supply. Leveraging a vast network of trusted suppliers and strategic partnerships, CSI ensures the timely procurement and delivery of ancillary items and services tailored to the unique requirements of each study. Supplier Network: CSI maintains a robust network of qualified suppliers, specialising in various ancillary categories, ensuring access to a diverse range of products and services to meet trial needs. Tailored Solutions: Understanding that each clinical trial is unique, CSI works closely with our clients to develop customized sourcing strategies aligned with study protocols. Quality Assurance: CSI prioritises quality and compliance, partnering with reputable suppliers and conducting rigorous quality assessments to ensure that all ancillary items meet regulatory standards. Logistical Expertise: With extensive experience in clinical trial logistics, CSI offers end-to-end supply chain management services, including warehousing, distribution, and inventory management, to ensure seamless delivery of ancillary items to clinical sites worldwide. By partnering with a trusted provider like CSI, our clients can access a comprehensive range of ancillary solutions tailored to their specific research needs, thereby enhancing the success of their clinical trials. We minimise wastage and administration from the sponsor, lower the number of invoices to process, complete the oversight of study requirements and reduce human capital investment from our sponsors.

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.

We are excited to attend this year’s Expopharm in Düsseldorf on 28th–29th September at the Messe exhibition centre. Our team is looking forward to engaging with key industry figures to explore the trends and cutting-edge advancements shaping the pharmaceutical and biotech landscape. You can schedule a meeting with our representatives, Stephan Mütze and Aylin Asadian, during the event. We look forward to meeting you!

CSI is excited to share that we'll be participating in the upcoming Clinical Outsourcing Group (COG) Conference in Milan on 10th–11th October at the NH Milano Congress Centre. Our Managing Director, Vanessa Dekou, will be hosting a session on Tuesday 10th October at 10.15am on Comparator Sourcing: An Enabling Step in the Process of Successful Clinical Trial Supply. This will cover how to manage risk in complex studies and strategies to deliver savings and value. Vanessa will also discuss the requirements, challenges and risks involved in different phases of drug development, provide tangible ways to identify and manage risks and present strategies for successful conduct for even the most complex adaptive trials. Join us at Booth 22 to engage with our team members, Stephan Mütze and Yasmine Clemson.

CSI is set to exhibit at this year’s Clinical Trial Supply (CTS) East Coast event held in Philadelphia, USA from 11–12 October at Sheraton Valley Forge, King of Prussia. Join us at Booth 36 to interact with our Director of Strategy, Andrea Giochetta, and Project Manager and Quality Associate, Nimrat Chahal. We are eagerly anticipating the chance to connect with you!

We are excited to attend Outsourcing in Clinical Trials DACH conference in Zurich on 21st–22nd November, which is taking place at the Movenpick Hotel Regensdorf. Stephan Mütze and Aylin Asadian from CSI’s Berlin office will be joining pharmaceutical and biotech experts to discuss the trends and challenges currently impacting the clinical trials community in the Germany, Austria and Switzerland region, and explore exciting opportunities for innovative clinical operations and outsourcing strategies. We’re looking forward to talking with you. Please book a meeting with us.

Clinical trials are the backbone of medical research, serving as a critical step in evaluating the safety and efficacy of new drugs and treatments. A key element of conducting successful clinical trials is the careful selection and sourcing of comparator drugs. Comparators, also known as reference drugs, play a vital role in comparing the effects of the investigational drug to an established standard of care. We explore the significance of clinical trial comparator sourcing, highlighting the importance of quality, reliability, and adherence to regulatory standards in this crucial aspect of the drug development process. Importance of Comparator Sourcing: Ensuring Validity of Trial Results: The choice of an appropriate comparator is essential to draw accurate conclusions from clinical trials. A well-selected comparator should have similar pharmacological properties and indications as the investigational drug, allowing for a fair comparison of their effects. Without a reliable comparator, the results of the trial may be compromised, rendering the study inconclusive or misleading. Safety and Ethics: Patient safety is paramount in any clinical trial. High-quality comparator drugs sourced from reputable and audited suppliers reduce the risk of adverse events and ensure that trial participants are provided safe and consistent medications. Ethical considerations mandate that the comparator drugs used have all been quality-certified, as the well-being of patients should never be compromised. Regulatory Compliance: Stringent regulatory requirements govern clinical trials to safeguard participants and maintain the integrity of scientific research. Comparator sourcing must adhere to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and meet regulatory standards in all regions where the trial is conducted. Failing to meet these requirements could lead to delays in trial approval or even trial termination. Challenges in Comparator Sourcing: Supply Chain Complexity: Clinical trial comparator sourcing involves complex supply chains that span different countries and regions. Managing logistics, safeguarding product integrity during transportation, and ensuring timely delivery present significant challenges for trial sponsors. Quality Assurance: The variation in the quality of comparator drugs sourced from different suppliers is a significant concern. Implementing robust quality control measures, including supplier qualification, auditing, and proper documentation, is essential to guarantee the reliability and consistency of the comparators sourced. Regulatory Variations: Each country and regions have their own specific regulatory requirements for clinical trial comparator sourcing. Understanding and complying with these diverse regulations necessitate a comprehensive understanding of the local and regional regulatory landscape. Best Practices in Comparator Sourcing: Thorough Supplier Qualification: Working with audited and reputable suppliers ensures the reliability and quality of the comparator drugs. Comprehensive supplier qualification processes should be in place, including audits, compliance checks, and adherence to GMP. Continuous Quality Oversight: Establishing a dedicated quality department to oversee comparator sourcing ensures ongoing compliance with quality standards and regulatory requirements throughout the trial. The sourcing of clinical trial comparators is a pivotal step in conducting successful and ethical clinical research. Ensuring the highest quality, safety, and regulatory compliance of comparator drugs is paramount to the validity of trial results and the protection of trial participants. By embracing best practices in comparator sourcing and addressing the challenges involved, the pharmaceutical industry can continue to drive medical advancements and improve patient outcomes.

The CSI team are attending the Clinical Outsourcing Group (COG) UK 2024 conference on 20th–21st February at the Leonardo Royal Hotel in London. Book a meeting with us or come to Booth 35 to discuss your upcoming study pipeline. We look forward to meeting you and all our industry associates!

The clinical trial supply chain is a critical component of drug development, involving the manufacturing, sourcing, packaging, labelling, storage and distribution of investigational and comparator drugs, as well as any additional supplies that might be required to conduct a study. Approaches to supply chain management are constantly evolving due to a variety of factors, and here CSI forecasts the potential trends and developments that are shaping the clinical trial supply chain and comparator sourcing industry. Advanced Technology Integration: AI-driven automation, forecasting and clinical trial design will continue to reshape supply chain management. These advancements will streamline logistics, reduce errors, and enhance traceability. Leveraging real-world data (RWD) through predictive AI models and analytics tools has the potential to accelerate the understanding of diseases, improve patient selection, inform site selection and innovate study design. Environmental Sustainability: There is growing emphasis on sustainable practices across industries. For the clinical supply chain, this means a shift towards reducing waste, optimising transportation to lower the carbon footprint and investment in EcoVadis accreditation. CSI has been awarded the silver EcoVadis award, as part of our commitment to sustainable procurement and environmentally friendly practices. Regulatory Changes: There is always a possibility that changes to regulatory requirements will be introduced, which can impact sourcing strategies, especially following the COVID-19 pandemic. Greater scrutiny and demand for quality assurance and traceability to mitigate risk will influence how companies’ source and manage comparators. CSI has an experienced Quality team who are dedicated to overcoming any regulatory challenges that arise, in a rapid and adaptive manner. Globalisation Challenges: Conflict, geopolitical issues, or changes to international trade agreements can impact the sourcing and distribution of clinical trial supplies globally. Companies will need to be adaptable and responsive to export and import obstacles that could arise as a result of these challenges. With over 100 years of combined experience, CSI possesses a wealth of expertise to overcome potential import or export difficulties that emerge. Focus on Cold Chain Logistics: Cold chain is getting colder! With the rise of biologics and personalised medicines, maintaining the integrity of temperature-sensitive products throughout the supply chain is crucial. Innovations in cold chain logistics and storage solutions are continuing to evolve, mitigating any potential temperature excursions. In partnership with our courier, CSI can tailor the best strategy for supplying any study, including direct-to-site shipments, local or regional depots and hybrid solutions. Focus on Patient-Centricity: Patient-centric trials may necessitate changes in the clinical supply chain to ensure timely and accurate delivery of investigational products to diverse locations, taking into consideration patient convenience and adherence. Follow the CSI page on LinkedIn to get the latest insights into emerging trends and innovations shaping the clinical supply chain industry in 2024. Contact CSI for your fully comprehensive clinical trial supply solutions.