Because the parameters of each trial are different, we treat each client’s project uniquely, offering advice and providing solutions to the client’s needs. Our team is in-house, full time, and highly experienced.
Quality and audited supply chains
A successful trial is impossible unless you can be assured that your supply of comparator medicines is secure, traceable and of the highest quality. Our Quality Assurance team ensures product quality control, including proper documentation (i.e. Certificates of Analysis (CofAs)/Certificates of Conformance (CofCs), Batch Release Certificates (BRCs), Statements of Authenticity (SofAs), etc).
To ensure we maintain the highest of standards in GMP, GCP and GDP compliance, our in-house Quality Assurance and Regulatory Departments include a Chief Technical Officer (CTO & QP), Head of Regulatory, Qualified Persons (QPs), Responsible Person (RP), Technical and Quality Officers, and pharmacists.
Because Clinigen is both a leader in Managed Access Programs (Idis MA) and the owner of our own medicines (Clinigen Specialty Pharmaceuticals), we have developed market-leading expertise in regulatory requirements for every region. We are routinely in contact with ministries of health and competent authorities such as the MHRA, EMA, FDA, and DEA.
Comparator medicines are not a commodity: they are made available for use in clinical trials on the basis of mutual trust. We have excellent contacts within the market, which have allowed us to develop both exclusive and ‘preferred partner’ relationships with several manufacturers because they know that we can be trusted with the supply of their products for clinical trials. Of the world’s top 20 pharmaceutical and biotech companies, 15 are our customers.
Project management team
Our project management teams are here to help you through the process of supplying your clinical trials.
Our project personnel are experienced logisticians who know that a secure, safe, and reliable supply chain is essential to a successful trial – but they also know that your needs, and those of the patient, are always paramount.
The project management teams are based in the UK and the US. With dedicated and experienced staff in both offices, the team provides tailored strategies for the sourcing and supply of commercial medicines needed for clinical trials. The team ensures our global clients can be individually supported in the time zone in which they are based, as well as ensuring they receive safe, secure medicines through a reliable, cost effective and audited supply chain. In the last 30 months, for example, we have successfully sourced over 1,380 different products in more than 30 countries for clients based around the world.