Within Services, Clinigen provides a unique set of niche, high value services to Pharma and Biotech clients prior to launch. This combined offering helps accelerate drug development plans and enable compliant early access for patients with unmet needs. The division comprises of two service lines:
Provision of innovative logistics, packaging, distribution and biorepository solutions alongside global sourcing and supply of comparator medicines, ancillaries, and devices for use in clinical studies to both industry and investigator led researchers.
Design and implementation of global Managed Access Programs (otherwise known as Compassionate Use, Named Patient, Early Access, or Expanded Access) to enable pre-approval access to innovative new medicines for the treatment of unmet medical needs.
Within Products, Clinigen enables access to critical medicines at a country, regional and global level. Our focus is to build a portfolio of specialist medicines to service the needs of healthcare professionals and patients in both licensed and unlicensed markets. The Products portfolio comprises three distinct strategies:
Medicines that have been acquired or developed by Clinigen. Clinigen acquires products with the goal to maintain access to those that rely on them and growing access into new markets and disease areas through a targeted product revitalisation strategy. Products developed in-house were previously supplied on an ‘on-demand’ form, the Unlicensed to Licensed (UL2L) strategy.
Partner of choice for Pharma and Biotech to provide access to their medicines in both licensed and unlicensed markets at a country, regional or global level through an exclusive access or licensing arrangement.
Sourcing and supply of unlicensed and short supply medicines in response to demand for access from healthcare professionals.