Whatever comparator you need for a trial, we will almost certainly be able to provide it. We can also source over 500 products for unlicensed import from around the world.
From the accurate application of randomisation codes onto double-blind trial bottle labels, to the timely and hassle-free international distribution of IMP and comparator products to multiple trial sites, our established global network and experience-honed team of experts are there to make sure clinical trials run smoothly and cost-effectively.
So as not to invalidate trial results, our quality management policies, accredited QP staff and auditable, ethical supply chain make sure that the comparators or IMP that we supply to clinical trials are of the highest quality. Our fully qualified and expert team is endowed with the skills and experience necessary to navigate even the most complicated of international regulatory, quality control and compliance environments.
POST TRIAL SERVICES
Our involvement need not end when a clinical trial is completed. Our range of unlicensed medicine services can help maximize the commercial value of an asset at either end of a product lifecycle.
At the end of a clinical trial there may be some subjects for whom the trial drug successfully met their medical need. In order to ensure continuity of care for these patients we can facilitate access to medicine on an unlicensed basis outside of the trial environment. This is often a more efficient and cost effective solution that the establishment of an open-label trial extension.
In an increasingly competitive and compliance-governed marketplace, it is imperative for pharmaceutical companies to maximise the commercial potential of their assets throughout the product lifecycle.
Our expertise, in the ethical and compliant manufacture and global distribution of high quality unlicensed medicines, allows us to provide support for the full lifecycle duration:
Early or managed access programs;
Label claim extensions;
Access provision in phased-launch and non-launch territories;
Collection of real world evidence to support licensing applications;
Market or product exit strategies to avoid negative impact on patient care.