Clinical Development Support
Your Clinical Development Program needs technical support to make your Clinical Studies a success. It is our passion to deliver high quality Investigational Medicinal Product to minimize the risk of a study failure. Our support to your Clinical Program covers:
Clinical Trial Supply
We manage all activities around Clinical Trial Supply for your Phase 1 to 3 Clinical Studies together with best-in-class contract manufactures, which includes:
– Manufacture of Investigational Medicinal Product (IMP)
– Design of packaging configuration
– Primary and secondary packaging
– Blinding – placebo and active comparator controlled studies
– Storage and distribution of IMP
– Batch release of IMP and Qualified Person Services
As the formulation of your compound might contribute significantly to the success of your Clinical Development Program, e.g. in case of a modified-release formulation, a sound understanding of drug release and pharmaco-kinetic/dynamic profile is mandatory. You will benefit from our broad knowledge during the approval process of several Modified Release products in the EU and US with unique drug release /pharmaco-kinetic profiles resulting in superiority over comparators in the Clinical Trials.
Drug administration in Clinical Trials is often challenging. We offer to write/ review your Pharmacy Manuals to improve the quality and, thus, increase the safety and efficacy of your drug.