Clinical Trial Manufacturing
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We offer you manufacturing and testing services for all major dosage forms including:
We have extensive experience developing and manufacturing drug products intended for all major routes of delivery:
Take advantage of our state-of-the-art containment manufacturing for handling high-potency products which features isolator technology and engineered controls. Our containment classification is based on the Performance-Based-Level of Exposure Classification (PBLEC) allowing us to handle levels 1 through to 5 (or down to 0.1 µg/cubic meter) dependent upon the type of compound, dosage form and batch size.
Quotient can support all aspects of your drug product supply to support your Phase I, II and Phase III clinical studies:
Our history and expertise of integrating manufacturing with clinical dosing enables us to manufacture, package and release products in a matter of days or weeks rather than months. Our approach maximizes flexibility around batch size and the timing of supply to your selected site, in response to emerging clinical data, or patient recruitment - all without affecting the availability of your drug product. Our approach can be used across all drug product types.
Our dedicated team of Project Managers is focused on delivering our customer’s clinical trial manufacturing projects on-time and on-budget. Quotient Project Management will provide end-to-end support from concept and project scoping, to project delivery, to making recommendations for late stage and commercialization. They will adapt along with your project to ensure your needs and the needs of your product are continuously met, that all risks are managed and mitigated and that all collaborators remain aligned with the objectives and end goal. And where projects transition across our sites, or intersect with other service providers, we’ll make the process is seamless for you. For more information about Quotient Project Management, click here.
Quotient Sciences has reached a clinical trial supply milestone, providing over 2,000 drug products to over 60 unique clinical sites in hospitals and contract research organizations worldwide. We have a strong track record of on-time delivery of clinical supplies supporting your Phase I and II clinical studies, managing the packaging, multi-language labeling and door-to-door logistics in accordance with your clinical design. Our clinical trial supply team works with you to design the most efficient process for drug product supply to your central hub or clinical sites including the provision of bulk drug product or individual patient kits.