We are pleased to announce that WPD Pharmaceuticals, a biotechnology research and development company with a focus on oncology and virology, has chosen to work with Clinigen Clinical Supplies Management for the QP certification and packaging & labelling of Berubicin for their Phase 2 adult and Phase 1 paediatric clinical trials. These trials are scheduled to start in February 2021 and May 2021, respectively.
As clinical services provider for WPD’s trials, Clingen Clinical Supplies Management will cover Qualified Person (QP) services to ensure that the Berubicin clinical product has been manufactured in accordance to the European Union Good Manufacturing Practice (EU GMP) standards. We will also be responsible for the packaging and labelling of the Investigational Medicinal Product (IMP), storage in accordance with the product specification, and release of the IMP to the clinical sites in accordance to Good Distribution Practice (GDP). Our collaboration is expected to last up to 3 years.
Clinigen’s QP team demonstrates our commitment to quality by consistently requiring stringent QA oversight. QP certification of the IMP is crucial to obtain the approval of the Regulatory Authority to initiate the clinical trials and we look forward to supporting WPD’s aims to conduct the clinical trials with the highest quality standards and in compliance with the applicable EU regulations and all applicable requirements including GMP.
At Clinigen, we design our clinical services around the needs of our clients and tailor our offering based on the specific requirements of the clinical trial. Since 1997, we offer a dynamic range of fully integrated services to meet the complex clinical supply challenges pharmaceutical and biotechnology companies face. Part of the Clinigen Group’s global supply chain facility and depot network, we combine market-leading clinical trial services such as comparator sourcing, packaging and labelling with biological sample management.
Contact us to learn more about our combined end-to-end clinical trial services and discuss how we may support your project.