Clinical phase

The most important factor on the way to marketing authorisation

The clinical trial is the most significant cost and time factor on the way to the marketing authorisation of your medicinal product. Numerous legal and regulatory provisions determine which clinical trials (in man for human, in animal species for veterinary medicinal products) have to be performed in order to demonstrate the efficacy and safety of your development.

Your product is at the focus

Medicinal product legislation offers various options – ranging from authorisations referring to other products to completely new marketing authorisations. This opens up a broad spectrum of possibilities for demonstrating the efficacy and safety of your medicinal product. We will show you the right strategy.

We clarify the scope of your clinical trial

In many cases it is possible to use existing data for marketing authorisation. We analyse which documents are already available and whether these can be incorporated in your marketing authorisation dossier.

A concept for your clinical development

In collaboration with you we develop a clinical development concept. In this connection we formulate a precise strategy. In addition, we schedule and hold meetings with the regulatory authority representatives, prepare all the necessary documents and prepare meeting minutes after scientific advices.

Detailed planning of clinical trials

On your behalf we draw up concepts and plans for the clinical trials and create all documents necessary for obtaining the approval of the regulatory authorities and ethics commissions. We advise you on the selection of the relevant issues, endpoints, study designs and study populations.

Seamless collaboration with CROs

Should you decide to commission a contract research organisation (CRO) to carry out your clinical trials, you can still count on our full support. We provide the following services:

• Planning and follow-up of your clinical trial
• Formulation of the clinical trial design and protocol
• Amendments
• Preparation of the clinical trial report
• Statistical analysis
• Drug safety during the clinical trial