Idis, A Clinigen

Our Story: Reaching More Patients, Touching More Lives

Clinigen has been accelerating access to life-changing medicines for over 35 years. We have grown to become a reputable global pharmaceutical company, standing at the forefront of managed access programs and clinical trial services. Our mission is deeply rooted in our belief that healthcare solutions should be accessible to those in need, regardless of location or circumstance.

Our story starts in 1981 with our founder's firm conviction that patients deserved better access to quality medicines, even in the absence of approval or reimbursement in their countries. Since then, we have built upon our ethos and strived to address unmet medical needs by pioneering programs such as Pre-approval and Managed Access programs. Today, we continue to help patients in every corner of the globe by celebrating and enriching the value of 35 years of client partnerships and breakthrough achievements in the managed access space.

How We Help: A Unique Combination of Services

Clinigen's core services cover both the clinical and commercial access arenas, enabling you to access innovative medicines for patients worldwide. Our distinct offering combines clinical expertise with a steadfast dedication to increasing the availability of groundbreaking treatments through managed access.

Clinical Services

We enable your critical medicines to reach more patients efficiently by delivering a range of services throughout the clinical development process. Our dedicated offerings include:

• *Clinical Trial Supplies*: Seamless, end-to-end supply chain solutions that ensure your products reach trial sites promptly and safely, improving study feasibility and speeding up development.
• *Packaging and Labelling*: Customised packaging and labelling solutions with unwavering accuracy, ensuring adherence to regional regulations while supporting informed consent for patients.
• *Comparator Sourcing*: Strategic and transparent sourcing of comparators for your clinical studies, saving you valuable time and resources.
• *Global Storage and Distribution*: Tailored distribution strategies compliant with local requirements and adherent to global supply chain standards, safeguarding your product's quality from the bench to the bedside.
• *Clinical Supply Chain Management*: Centralised and strategic management of your supply chain, mitigating risks and ensuring prompt delivery of life-changing medicines.
• *Returns, Reconciliation, and Destruction*: Compliant and flexible disposition of unutilised or returned products, securing the integrity of your investigational medicines.
• *QP Services*: Quality assurance for your investigational medicines and APIs, ensuring compliance with European regulations.
• *Controlled Drug Services*: Full-service management of controlled and narcotic drugs in clinical trial supply, ensuring safe allocation, transport, and storage.
• *Specialty Services*: Advanced, customer-focused services encompassing, for example, biological and cold-chain management, formulation development, and stability testing.
• *Biological Sample Management*: Skilled and secure sample management from collection, preparation, and storage - to analyses and archiving.
• *Biorepository Services*: End-to-end biological specimen storage, distribution, and collection solutions with continuous quality oversight.

Access and Commercialisation

Our extensive experience in market access, pre-approval, and managed access programs ensure that your innovative medicines can have a positive impact on patients' lives by providing:

• *Global Partnering*: Collaborative efforts in licensed and unlicensed distribution, delivering the ultimate reach for your medicines and services.
• *Market Access*: Pragmatic insights and strategic consulting on market access, compliance, and reimbursement for local and global markets.
• *Pre-approval and Managed Access*: Adaptive and timely access to medicines prior to market authorisation, supported by extensive safety, risk management, clinical, and regulatory plans.
• *Real World Data*: Pragmatic, late-phase data generation and protocol design options to enhance your understanding and identification of real-world benefit and value.
• *Pharmacovigilance*: Optimal monitoring, safety reporting, and risk minimisation, safeguarding the integrity of the medicines you bring to market.
• *Regulatory Affairs*: Skilled regulatory affairs support, seamlessly navigating the path to market authorisation.