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

Formulation

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.

Pharmacy Manuals

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.