Insight
Case Studies
We have a track record of innovation, problem solving and exceptional client service. Read on to learn more about how we accelerate access to innovative medicines across the lifecycle.
Clinical Trial Sourcing
Read the case study to learn how Clinigen provided an innovative comparator drug sourcing solution to reduce trial costs by 60% for the investigator.
Learn how Clinigen's On-Demand comparator sourcing model benefited a recent multi-country global clinical trial for a large pharmaceutical company.
Clinical Supplies Management
Read the case study to discover how Clinigen provided a viable packaging and labelling option in compliance with a trial's ultralow cold chain requirements.
Discover how Clinigen created a tailored Direct-to-Patient shipping solution for a sponsor, enabling quick, efficient turnarounds.
Learn how Clinigen's On-Demand method helped a sponsor to package and label an Investigational Medicinal Product (IMP) within 48 hours.
Learn how Clinigen's biomedical sample management expertise provided an integrated solution for a client's complex global study, improving traceability and reducing risks and costs.
Learn how Clinigen provided a customised and sound clinical supply strategy to investigators using a product from a top 10 pharmaceutical company.
Learn how Clinigen used it's Qualified Person (QP) expertise to help a sponsor's contract manufacturing organization (CMO) in China import an investigational medicinal product (IMP) into the EU.
Managed Access
Read the case study to discover how Clinigen enabled the company to provide pre-launch access to more than 5,000 patients with unmet medical needs and ensure fair and equitable access across all countries and populations.
Read the case study to discover how Clinigen enabled the company to provide pre-commercial access to 400 patients across Europe.
Read the case study to learn how Clinigen worked with 300 healthcare professionals to provide treatment to 950 patients.
Read the case study to find out how Clinigen ensured patients were not negatively impacted by the closure of the trial.
Read the case study to understand how Clinigen provided access to over 130 patients and implemented a sustainable and self-funding program that could be continued for many years where needed.
Read the case study to learn how the ongoing program gave access to 10,000 patients globally on a named-patient basis where there was a clear unmet medical need.
Read the case study to learn how Clinigen provided the treatment free of charge under Early Access regulations in the US.
Lifecycle Services
Pharmacovigilance
Read the case study to learn how Clinigen enabled our customer to successfully launch their very first product in multiple markets.
Read this case study to learn how Clinigen rapidly scaled pharmacovigilance operations for a US biotech company facing a sudden surge in oncology product cases.
Regulatory Affairs
Read this case study to learn how a small US-based biotech company partnered with Clinigen to establish a compassionate use program in Europe, ensuring regulatory compliance and preventing illegal supply of their innovative treatment for glioma.
Read this case study to learn how a pharmaceutical company partnered with Clinigen to successfully enter the African market with their new breast cancer treatment through unlicensed patient access.
Read this case study to learn how Clinigen supported a German pharmaceutical company in expanding its haematology oncology product into the Asia Pacific region, ensuring regulatory compliance, commercial viability, and life-saving access for patients with an orphan condition and unmet medical needs.
Read this case study to learn how Clinigen's multi-market submissions expertise played a pivotal role in the successful registration of an anti-cancer medicinal product in Australia, including transition from the EU eCTD format to the Australian eCTD format.
Read this case study to learn how Clinigen’s Exploitant services facilitated the entry of a haematology drug into the French market and provided ongoing regulatory support, ensuring market presence and operational efficiency.
Read this case study to learn how Clinigen developed a comprehensive regulatory market access strategy for a US biotech company, enabling the successful global commercialisation of their innovative endocrinology products through tailored regulatory guidance, strategic planning, and educational support.
Read this case study to learn how Clinigen supported a global mid-sized pharmaceutical company in streamlining its operations and divesting a portfolio of niche hospital products.
Read this case study to learn how Clinigen supported a client in achieving MHRA compliance by providing end-to-end support for a packaging redesign.
Read this case study to learn how Clinigen’s strategic regulatory support, and efficient management of a mature hospital-use IV product, ensured sustained compliance, market expansion, and revenue protection.
Read this case study to learn how Clinigen facilitated a license transfer, enabling a successful acquisition and seamless integration of biological oncology product within a complex regulatory landscape.
Read this case study to learn how Clinigen's strategic regulatory support and innovative approach to indication expansion enabled our client to regain their competitive edge in the market.
Read this case study to learn how Clinigen supported a Japanese pharmaceutical company in entering new markets with its innovative treatment, making it available to patients and ensuring regulatory compliance.
Read this case study to learn how Clinigen’s strategic regulatory support and comprehensive management of Decentralized Complex Procedures ensured a successful entry for a niche generic product in 11 EU markets.