Clinigen

Kinesys Consulting specializes in providing strategic development, regulatory affairs, and consultancy services to the biotech and pharmaceutical industries. With a focus on oncology, orphan drugs, and medical devices, the company aims to support clients through the complex landscape of drug development and market authorization.

Drug Safety Navigator specializes in safety and pharmacovigilance consulting for small to mid-sized pharmaceutical and biotech companies. The company offers a comprehensive suite of services, including adverse event reporting, case management, benefit-risk assessment, and medical writing. Additionally, Drug Safety Navigator provides virtual safety department support and global pharmacovigilance for both clinical and post-marketed medical products. With a focus on regulatory compliance, their expertise aids clients in navigating the complexities of patient safety and ensures effective monitoring and reporting of adverse events.

CSM Parent, Inc. provides packaging, labelling, warehousing, and distribution services.

Clinical Supplies Management (CSM) specializes in addressing the intricate supply challenges faced by biotech and pharmaceutical companies during clinical trials. The company offers comprehensive clinical trial and biological sample management services, which include packaging, labeling, storage, distribution, and consulting. By utilizing a combination of traditional and innovative approaches, CSM provides customized solutions that enable clients to efficiently manage drug supplies and ancillary materials, even in the face of time constraints and mid-study changes. Their extensive network and proprietary ERP systems facilitate the seamless execution of clinical trials, helping clients in the pharmaceutical, medical testing, biotechnology, and healthcare sectors to conduct efficient and effective studies while minimizing waste and costs.

iQone Healthcare Holding is a specialty pharmaceutical company based in Versoix, Switzerland, established in 1979. The company focuses on therapeutic areas including oncology, hematology, immunology (specifically rheumatology and gastroenterology), and conditions related to bones and tissues. iQone Healthcare collaborates with Asian and American firms seeking to enter the European market, offering support through partnerships for commercialization or by assisting in the establishment of their own entities. This strategic approach allows iQone Healthcare to provide effective treatments and medicines to patients and healthcare professionals across Europe. As of October 2018, iQone Healthcare operates as a subsidiary of Clinigen Group Plc.

International Medical Management Corp. provide medical supply consulting services to the Japanese health care community.

Quantum Pharma is a niche pharmaceutical developer, manufacturer, and supplier catering to the retail pharmacy, pharmaceutical wholesaler, and hospital markets. The company operates through two divisions that encompass seven business units across six locations in the UK and Europe. It provides a diverse portfolio of innovative products and services designed to meet the specific needs of its clientele.

Totect is a manufacturer of dexrazoxane, the first and only treatment approved by the United States Food and Drug Administration for anthracycline extravasation. This emergency medicine is designed to reverse the toxic effects associated with anthracycline chemotherapy, helping to mitigate potential complications and reduce the need for surgical intervention. Through its innovative product, Totect addresses a critical need in cancer care, providing an effective solution for managing the adverse effects of chemotherapy.

Link Healthcare is a specialist pharmaceutical company based in Warriewood, Australia, focusing on markets in Asia, Africa, and Australasia. The company provides a range of services, including pharmaceutical sales and marketing, regulatory compliance, medical affairs, and pharmacovigilance. Additionally, Link Healthcare offers logistics and pharmaceutical licensing services for clinically significant pharmaceuticals, ensuring that products meet the necessary standards and regulations in the Australian market. Through its expertise, Link Healthcare aims to enhance the availability and compliance of important medical products in its targeted regions.

Around the world, patients with unmet medical needs are frequently driven to seek access to medicines outside the clinical trial and commercial setting. Idis is the leading expert in developing, implementing and managing global Managed Access Programs by which pharmaceutical and biotechnology companies and healthcare providers can respond to the needs of these patients. Idis has over 27 years experience of partnering with pharmaceutical and biotechnology companies to create regulatory-compliant, ethical access to medicines for healthcare professionals and their patients with unmet medical needs. Since 1987, Idis has developed and managed access to thousands of medicines from virtually every therapeutic category, impacting the lives of hundreds of thousands of patients. Around the world, a variety of terms are used to describe these programs including “expanded access”, “named patient”, “ATU”, “compassionate use”, and “early access”.

Clinigen CTS Limited supplies drugs and ancillaries for global trials.