About Clinigen Clinical Supplies Management
Since 1997, Clinigen Clinical Supplies Management has offered a dynamic range of fully integrated services to meet the complex clinical supply challenges pharmaceutical and biotechnology companies face. Part of the Clinigen Group’s global supply chain facility and depot network, it combines market-leading clinical trial services such as comparator sourcing, packaging and labelling with biological sample management. Clinigen Clinical Supplies Management delivers tailored solutions for clients to ensure their clinical trials are a success, regardless of size or scope, from Phase I to Phase IV projects.
Clinigen tailors their services to meet the exact needs of their client’s clinical trial, which is overseen from start to finish: from logistics planning, comparator sourcing, and inventory control to packaging and labelling and project budgeting. Project requirements are accommodated to help avoid any potential issues and time conflicts, while mitigating costs to further ensure that the study is both time- and cost-efficient.
Rather than working with several providers, clients benefit from having one point of contact, one solution, and one contract, which is refreshingly easy and effective.
They offer GMP and cGMP compliant procedures and processes, and their own highly-trained team will work with each client to meet protocol-specific needs while additionally ensuring the necessary compliance and safety procedures are met. Their commitment to quality is proven by the hundreds of successful client audits of their global sites. Clinigen's facilities and equipment are customised for the packaging & labelling, storage, and distribution of clinical supplies and scaled for the needs of clinical studies of all phases, from small but complex Phase I studies to high volume Phase III studies, as well as Phase IV studies. At their dedicated GMP sites in the US and EU, they manage the clinical trial supplies process for hundreds of clinical studies worldwide. All facilities and equipment have been fully validated/qualified and calibrated.
Clinical Trial Supply Chain Management Services Include
- VRS/IWRS Management
- Logistics Planning
- Global Distribution and Importation
- Cold Chain
- Comparator Drug
- Inventory Control
- Controlled Drug and Substance Handling
- Global Studies Management (including QP release)
- Unique Packaging and Labelling Solutions & Operations
- Label Text Generation, Translation, and Approval
- Project Budgeting
- Returns and Destruction
- Batch Record Review and Approval
Clinigen’s experienced supply chain management consultants ensure their clients consistent results throughout the duration of their project. Their tailored approach allows them to quickly adapt their services as a study evolves. What’s more, they include a backup clinical support services project manager who can seamlessly take control of a project if the lead clinical trial project manager is unavailable.
For global clinical trials, Clinigen provides a project manager in one of their sites who specifically works to assist and manage activities globally with the whole project management team. Simply put, Clinigen’s teams bring the expertise and background needed to ensure a smooth and personalised supply process for every trial, no matter how complex the project.
About Clinical Trials Innovation Programme
Clinical Trials Innovation Programme is an invitation-only, premium event bringing together a mix of clinical research professionals and service providers in one stimulating environment.
Join us face to face to learn from the best in the drug development industry and have an opportunity to learn from their experiences. With an agenda covering the future of Clinical trials and drug development post COVID, Clinical Trials Innovation Programme 2022 will feature tailored sessions presented by the leading experts from across the globe.
We are bringing together the best in the industry to help you learn and grow, and accelerate your drug development journey. The experts will include thought leaders and visionaries from Danish Medicines Agency, Bayer Pharmaceuticals, AstraZeneca, The Janssen Pharmaceutical Companies of Johnson & Johnson, Travere Therapeutics, Biogen, Vifor Pharma, Medical Products Agency and much more.