Introduction

Clinical trials are increasingly complex, global and expensive, with pharmaceutical and biotech companies under  pressure to design and execute studies faster and more efficiently than ever.

At Clinigen, we clear your path toward clinical trial success. Our market leading comparator and commercial medicines sourcing business is now combined with the power of CSM’s agile, innovative approach to clinical trial supplies and biological sample management to offer a global end-to-end service without compromise. To find out more about our packaging, labelling and distribution capabilities as well as our specialized service solutions, please visit www.csmondemand.com.

We know that every clinical trial has its own parameters and presents its own challenges. That’s why our Clinical Services team has the deep experience and expertise needed to ensure that your trial is supplied with quality-assured comparator and other commercial medicines and design a packaging, labelling and distribution strategy to increase speed, drive down cost and ensure vital medicine reaches patients, regardless of where they are in the world or whether they will be dosed at a site or in their home.

Clinigen is a leading provider of clinical trial supply solutions for pharmaceutical and biotechnology companies worldwide. By acting as an extension of your team we maximise your success, and by leveraging the global footprint and experience of the Clinigen Group you can be sure we remain the right partner whatever challenges you face, and wherever in the world you end up.


Key Facts

30+

years' experience as the global leader in providing access to medicines

350+

employees dedicated to clinical services across the US, Europe and Asia

1.5m

units shipped in the last year

19

of the top 20 pharmaceutical companies are our customers

Clinigen provides unparalleled expertise and global experience in the specialist supply and management of quality-assured medicines for patients in clinical trials: 

  • Smart sourcing strategies keep your clinical trial spend within budget
  • Unrivalled access to medicines and ancillaries, working directly with a global network of manufacturers, approved distributors and audited suppliers
  • Over 20 years’ experience in primary and secondary packaging, labelling and distribution across our sites in Asia, Europe, UK and US
  • Pioneers in On-Demand packaging and Direct-to-Patient distribution.
  • As a pharmaceutical company ourselves we have unparalleled experience in ensuring the highest quality control and compliance standards
  • A global logistics network with local, regional and central distribution capabilities, ensuring medicines get to site quickly, in the right quantities and accurately labelled
  • Experience operating in 130 countries, using our local and global regulatory expertise to help pharmaceutical companies, pharmacists and physicians around the world to ethically gain access to medicines for the patients who need them

How we help

Clinical Services offers comprehensive, customised and smart solutions for any clinical trials supply scenario. We ensure pharmaceutical and biotech companies run highly effective trials by minimising cost, improving efficiencies and maximising access. 

Our dedicated Project Managers support you through the entire development process, designing and deploying flexible, efficient strategies to meet your specific needs:

Comparator Sourcing and Ancillary Supply

Unparalleled access to quality assured products from around the world. Clinical Services boasts exclusive and preferred relationships with numerous branded and generic manufacturers, plus an extensive global network of approved and audited wholesalers and distributors.

Read more about Comparator Sourcing >

Packaging & Labeling

Clinigen offers Primary, Secondary, Traditional and On-Demand clinical packaging and labelling at all temperatures out of 44 GMP packaging rooms across 6 sites in the US, UK, EU and Asia.

To find out more about our packaging, labelling and distribution capabilities, please visit www.csmondemand.com.

Read more about Packaging, Labeling and Distribution >

Global Storage and Distribution

Across 10 Clinigen Group sites, our network of approved partner depots and with purpose built ERP system we ensure your products are stored and shipped safely and efficiently, whether to depots, sites or directly to patient’s home.

Read more about Packaging, Labeling and Distribution >

Investigator Initiated Trials

As a pharmaceutical company supporting IITs we understand their unique challenges. that’s why we’ve designed suite of services designed to simplify IITs regardless of size or scale.

Read more about Investigator Initiated Trials > 

Direct-to-Patient (DtP)

Addressing the challenges of patient enrollment and retention Clinigen and CSM are pioneers in Direct-to-Patient delivery, having successfully delivered more than 5,000 shipments to over 2,500 patients.

Returns, Reconciliation and Destruction

Clinigen manages returned drug accountability, reconciliation, and destruction across all product types and temperature ranges.

Qualified Persons (QPs)

Clinigen can support all of your QP release, declaration, confirmation and certification needs, including product import, with 10 QPs on the licenses at our continental European sites and a further three in the UK.

Biological Sample Management

Operating from sites in the US and Europe we offer safe, efficient and cost effective biological sample management solutions. Whether your storage need is short or long term our experienced team can help, and has worked with clients across pharmaceuticals, biotechnology, academia and central labs on over 750 studies and has assembled over 450,000 patient collection kits.

To find out more about our biological sample management capabilities, please visit www.csmondemand.com.

Controlled Drug Services

Our global distribution services are certified and registered in controlled drug handling and services include five U.S. DEA registrations:

  • Manufacturer
  • Importer
  • Exporter
  • Distributor
  • Retail Pharmacy Service