End-to-end clinical trial services

Whether you have large scale, smaller scale or more complex packaging and labelling needs, require access to difficult to source comparator medicines, have stringent cold chain requirements, or are looking for supply chain management consulting, Clinigen acts as your clinical trial supply partner at every step of the way.

 

PACKAGING & LABELLING Services

Clinigen Clinical Supplies Management is focused on providing innovative, flexible and efficient packaging and labelling services for clients’ clinical trials. We offer traditional, larger scale clinical packaging and labelling, as well as On-Demand and Direct-to-Patient packaging services, including cold chain packaging and labelling solutions from Phase I to Phase IV projects. Over 80% of the trials we are supporting are multinational and our global capabilities enable us to support large scale projects. Discover how we supported a recent Phase III multinational trial involving 28 different sites across Europe and the US on the blog.

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Packaging & Labelling Services

 

COMPARATOR DRUG SOURCING

Our market-leading comparator drug sourcing services provide unrivalled access to comparator drugs and ancillary supplies. Our team is dedicated to supporting clinical trials across the US, UK, Europe, and Asia. Thanks to our deep knowledge and established relationships across the manufacturer landscape, we offer smart sourcing strategies that keep your clinical trial spend within a budget. In addition, our direct relationships with suppliers allow us to deliver quotes within 48 hours. To learn more about our innovative On-Demand consignment model, read our case study.

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Comparator Sourcing Services

 

STORAGE AND DISTRIBUTION SERVICES

With partners strategically located around the globe, we support clients with international clinical trial storage, shipping, and distribution processes. Our team has managed the clinical supply chain for over 700 global trials, including those requiring cold chain logistics. Clinigen’s GMP/cGMP-compliant storage facilities, as well as our cold chain storage and distribution services, offer a variety of controlled environmental conditions to accommodate your clinical trial’s unique supply demands. Our validated shipping systems provide safe and efficient solutions along the entire cold supply chain, ensuring best in class supply chain management.

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Storage & Distribution Services

 

SUPPLY CHAIN MANAGEMENT SERVICES

Our 20+ years of experience in supply chain management allows us to bring the expertise and background needed to ensure a smooth supply process, even for the most complex of clinical trials. Clinigen Clinical Supplies Management is focused exclusively on clinical, ensuring the best methods and practices are tailored to your specific clinical study. From customising clinical trial study designs to applying cost-effective methods for the clinical supply chain, we help clients plan and execute projects of all sizes and scopes. Read some of our tips on how to streamline the clinical trial supply chain on the blog.

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Suppy Chain Management Services

 

RETURNS, RECONCILIATION, AND DESTRUCTION

Our mission is to help you manage your clinical supply strategy through every step of your trial –accommodating inevitable changes during the process, right up until the end of a study. Choosing the most appropriate system at the start of a clinical study can have an impact on your trial’s cost-efficiency. As such, we effectively manage returned drug accountability, reconciliation, and destruction for our clients’ clinical studies. We offer GMP and cGMP compliant procedures and processes, and our highly-trained team works with each client to meet protocol-specific needs while additionally ensuring the necessary compliance and safety procedures are met.

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Returns, Reconciliation & Destruction Services

 

QP SERVICES

We demonstrate our commitment to quality by consistently requiring stringent QA oversight through our Qualified Person (QP) services. With our two established sites in the post-Brexit EU, our in-house QPs can support both EU and UK drug product release and batch certification, mitigating any Brexit-related risks for your clinical trial. We ensure that the clinical product your study calls for has been manufactured and/or imported in accordance with EU GMP or equivalent satisfactions.

Read this case study to learn about how we helped a Contract Manufacturing Organization (CMO) take an investigational medicinal product (IMP) into Europe.

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QP Services

 

Whatever your trial’s particular needs, we tailor our clinical trial supply services around your study. As part of Clinigen Group, Clinigen Clinical Supplies Management gives you the choice between a combined end-to-end offer that supports the entire clinical supply chain and our ready-made offerings in clinical trial supplies and biological sample management.

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As a leading provider on a global scale, Clinigen is committed to delivering fully integrated logistics services to our clients. Over 80% of the studies we are supporting are multi-national and we organise shipments to 110+ countries.