You have a plan …

… which goal you want to achieve with your product. Sometimes our clients have a very clear idea which clinical study is needed and sometimes they even come with a ready-to-go study protocol. But this is not always the case. If you are interested in improving your strategy or maybe you do not know how to reach your goal – but want to reach it with as little effort as necessary – then it is our job to support you.

Wherever we can contribute to help realizing your project – we will!

The most direct route to the goal

Our team of pharmacists, clinical pharmacologists, pharmacokineticists and biostatisticians as well as our network of excellent clinicians with practical as well as conceptual background will support you and your team in finding the best solution. We are accustomed to setting up the basic principles of a trial design as a basis for further discussions and to lead it to a final protocol which will ultimately reach authorities’ acceptance.

If you wish to be supported co-ordinating the discussion with internal and external experts we will enjoy assisting you.

But if the route is not yet clear …

Sometimes, it may be necessary to go back to the scientific basis to develop the best way. Adequate endpoint definition, identification of the minimal clinically important difference, sample size estimations – such aspects may require more effort than expected at first glance. In such a case our group at SocraTec C&S is available for consultation. Our support helps your study to satisfy the requirements of the applicable statutes and regulations depending on your target area for approval, not only in Europe or the U.S. but also in Switzerland, Australia or Japan.

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