Clinigen Clinical Supplies Management

Clinigen combines market-leading clinical trial supplies such as packaging and labelling, global storage and distribution, comparator sourcing, as well as biological sample management services. Part of Clinigen’s global supply chain facility and depot network, we deliver tailored solutions for clients to ensure their clinical trials are a success, regardless of the size, scope, or stage of the projects.

We provide our clients access to 25+ years of clinical supply expertise and industry best cycle times.

Tailored Clinical Trial Services

As part of Clinigen Group, Clinigen Clinical Supplies Management gives clients the choice between a combined end-to-end offer that supports the full life-cycle of medicine and our 25+ years of experience in ready-made offerings in clinical trial supplies and biological sample management.

Whether we serve as the client’s clinical supplies department or augment their in-house capabilities through our clinical services, we provide one point of contact, one solution, and one contract.

Our biological management services aim to meet the precise needs of clinical studies, creating customised solutions according to specific requirements.

Smart Comparator drug and ancillary supplies sourcing strategies to keep clinical trial spend within budget.

Clinigen has 25-plus years of experience and expertise in storage and distribution solutions.

Offering traditional clinical packaging and labeling, as well as On-Demand and Direct-to-Patient services.

We tailor our services to meet the exact needs of each clinical trial, which we oversee from start to finish: from logistics planning, comparator sourcing, and inventory control to packaging and labelling and project budgeting.

Comparator Sourcing & Speciality Services

Our market-leading position in Comparator Sourcing, as well as our long-standing experience with our speciality services like On-Demand Packaging & Labelling, Investigator-Initiated Studies (IIS), and Direct-to-Patient (DtP) services is what makes Clinigen Clinical Supplies Management stand out.

Comparator Sourcing:

As market leaders in Comparator Sourcing, Clinigen offers smart and flexible strategies to provide you with unrivalled access to medicines and ancillaries, as well as direct access to a global network of manufacturers, audited third-party suppliers, and approved distributors.

Our efficient sourcing capabilities provide you with access to comparator drugs, standard of care and adjuvant therapies, reference listed drug (RLD) samples, rescue medications and ancillaries for use in clinical trials.

With our exclusive and preferred-partner relationships with manufacturers, we offer valuable local and global knowledge across the manufacturer landscape.

On-Demand Packaging & Labelling:

Our Clinical Supplies Management team can work with you to start a new clinical trial with quick turnaround times and can process new shipment requests or make changes to the trial within five working days.

This flexibility allows you to save costs, use your drug product in multiple protocols, and avoid waste. Expensive and limited supply medicines can greatly benefit from the On-Demand method.

Direct-to-Patient:

With over a decade of experience in managing DtP studies, we have delivered over 7000 DtP shipments to trial patients to date. A traditional trial can be turned into a DtP trial either partly or completely.

We also provide site-to-patient shipments and can adapt your trial quickly, as needed. Benefits include reducing the number of patient drop-outs and the overall cost of a study, as well as access to a Wider Patient Population.

IIS Services:

Thanks to our decades of experience providing Investigator-Initiated Studies Services, our unique perspective enables us to provide smart and flexible processes that operate as if they were outside of a clinical study.

When it comes to distribution, we have managed regulatory pathways required to facilitate the movement of materials in support of the IIS and EAP programs on an international level.

Biological Sample Management:

With over 25 years of experience in biological sample management, Clinigen’s pioneer services reduce costs while maintaining the required quality of your biological samples. We handle more than biorepository services, samples logistics, and sample collection kit design and assembly.

We also offer sample de-identification, consultations, and project management services. Our staff has served clients in academia, pharmaceuticals, biotechnology, and central laboratories.

QP Services:

We focus on providing the best Qualified Person (QP) services for our clients’ clinical trial supply needs. Our certified QPs can support both EU and UK drug product release and batch certification, mitigating any Brexit-related risk for a clinical trial.

About Clinigen Clinical Supplies Management

Clinigen Clinical Supplies Management is part of Clinigen, a global pharmaceutical and services company with a unique combination of businesses focused on providing access to medicines to improve the quality of people’s lives around the world.

Clinigen’s mission is to deliver the right medicine to the right patient at the right time by following our vision to become the global trusted leader in access to medicines.

At Clinigen Clinical Supplies Management we value quality above all else. With Clinigen as your clinical supplies partner, you can expect reliable and innovative services that deliver outstanding results.

With each client, we develop a strategy for success that begins with a deep understanding of your study’s specific needs.

Our trusted processes and open mindset allow for customisable solutions and flexibility during each step of the clinical supply chain.

Our customers experience faster startup times than the industry average and the ability to make changes to their study without any schedule impact.