Introduction

Pharmaceutical and biotech companies are coming under increasing demands to maximise the potential of their asset throughout the entire product lifecycle. This, coupled with growing recognition of the need to provide patient access to medicines for clinical trials and unlicensed and licensed supply, raises multiple challenges at each point of access, spanning the lifecycle from post-trial access to market exit globally.

Clinigen is the global leader in the specialist management of ethical, regulatory compliant and efficient solutions to help pharmaceutical and biotech companies provide access to medicines. We are dedicated to delivering the right medicine to the right patient at the right time through three areas of global medicine supply:


Clinigen Working For Pharmaceutical and Biotech Companies

Clinigen’s business model, experience and pedigree enable us to effectively operate in a complex global regulatory environment, and ensure that precious medicines are delivered securely and effectively for both pharmaceutical and biotech companies, whenever they are needed, throughout the product lifecycle.

The benefits of enabling access to medicines are significant, not just for patients and healthcare professionals, but also for pharmaceutical and biotechnology companies that invest a huge amount to develop and commercialise these medicines. Clinigen’s experience and expertise in providing access across the entire lifecycle of a medicine helps ensure these benefits are realised.

Key facts

250+

partnerships with pharmaceutical and biotech companies

1.7m

clinical trial units shipped in the last 3 years

250+

experience running over 250+ access programs

130+

provide access in 130+ countries


How we can help

Through Clinigen’s insight, we have a deep understanding of the challenges you face, and our experience enables us to provide effective solutions to help you meet them, adding value at every stage of a product’s lifecycle:

  • Trusted to manage early access to the most promising and innovative new medicines across almost every therapeutic area for both large and small pharmaceutical and biotech companies
  • Experience in providing access to medicines at all stages of the product lifecycle on a global basis
  • Local market knowledge and global regulatory expertise across 130 countries, providing expertise in navigated local requirements and ensuring effective operationalisation of programs
  • Supporting pharma companies to move their assets from an unlicensed medicine to a licensed medicine ensuring successful transition and commercial launch
  • Trusted by more than 6000 Healthcare Professionals to provide access to medicines for their patients, and enabling convenient 24/7 access to medicines and information for healthcare professionals through our online portal.

Clinigen’s unparalleled experience and expertise enables pharmaceutical and biotech companies to provide access to innovative medicines to address unmet patient need and maximise the value of your asset. We get medicine. You get:

Trusted lifecycle partner

Clinigen will support you throughout all three phases of the drug lifecycle, providing effective management of your asset from clinical trials, through to unlicensed and commercial supply. Our unique experience enables us to help you ensure patients get medicine access whilst maximising the value of your asset through ensuring the right patients gets access to your medicines at the right time.

Experience and expertise

With 30 years' unrivalled experience in providing healthcare professionals with access to medicines, we have the depth and breadth of expertise to ensure efficient, compliant and successful management of your unlicensed and  licensed medicines. Your dedicated Clinigen project team will ensure pitfalls are avoided, your reputation is protected and that healthcare professionals get access to the medicines they need. Strategic guidance and operational management is provided throughout all stages of your program. 

Operational excellence

Our world-class, global Medicine Access teams, providing local service in over 25 languages, ensuring healthcare professionals have a positive experience when gaining access to your medicine. Our in-house expertise supports all elements of your program, including quality assurance, regulatory, medical information and pharmacovigilance, providing a complete outsource solution. Always working within the appropriate legal, regulatory and ethical frameworks, our global team ensure delivery of the right medicine in the shortest possible time.