WPD Pharmaceuticals Contracts Clinigen Clinical Supplies Management to Perform QP Certification of Berubicin for the Clinical Trials Authorization
VANCOUVER, British Columbia, Jan. 14, 2021 (GLOBE NEWSWIRE) -- WPD Pharmaceuticals Inc. (CSE: WBIO)(FSE: 8SV1) (the “Company” or “WPD”) a
clinical-stage pharmaceutical company, is pleased to announce that it has signed a contract with Clinigen Clinical Supplies Management (“Clinigen”), a leading clinical supply
management business, to provide critical services during the Berubicin phase 2 adult and phase 1 pediatric clinical trials which are scheduled to start in February 2021 and May 2021,
For nearly half a century, Clinigen has built a reputation as one of the most trusted specialty logistics company in the world through its unsurpassed knowledge, global reach and flawless supply chain execution. Clinigen’s global supply chain facility and depot network combines market-leading clinical trial services such as comparator sourcing, packaging and labelling with biological sample management. Clinigen delivers tailored solutions for clients globally to ensure clinical trials are a success, regardless of size or scope, from Phase I to Phase IV Trials.
For WPD’s trials, Clinigen will cover Qualified Person (QP) services for ensuring and confirming that the Berubicin clinical product has been manufactured in accordance to the European Union Good Manufacturing Practice (EU GMP) standards. Clinigen will also be responsible for packaging and labeling of the Investigational Medicinal Product (“IMP”), storage in accordance with the product specification and release of the IMP to clinical sites in accordance to Good Distribution Practice (GDP). QP certification of the IMP is crucial to obtain approval of the Regulatory Authority and to initiate the clinical trials. WPD aims to conduct the clinical trials with the highest quality and in compliance with the applicable EU regulations and all applicable requirements including GMP. The services provided by Clinigen are expected to last up to 3 years.
Mariusz Olejniczak, CEO of WPD commented, “We are very pleased to cooperate with Clinigen in the upcoming Berubicin trials. Clinigen has significant global experience in the Qualified Person services and clinical supply management and we are sure that Berubicin IMP authorized to the clinical trials and given to the patients will be of the highest quality. Clinigen is an important part of the framework and strategy we are building to execute on the successful trials for Berubicin."