Proof of concept

Leading the way in the very early stage of development

The overriding challenge in drug development today


Drug development is struggling with ever-increasing time-consuming procedures and constantly rising costs. Thus, pharmaceutical companies and biotech enterprises need more efficient drug development strategies to bring new active compounds to market faster and more cost-effectively.

The overriding challenge in drug development today is to prove superiority of the new drug within a reasonable time frame and the available budget. Otherwise marketing of the new drug for return of invest might fail.

In recent years the development of several new pharmaceutical compounds has been suspended, because they were no better in terms of efficacy, tolerability and safety than existing drugs already on the market.

To avoid such failures in drug development and prevent wasting costs and time, the conduct of Proof-of-Concept (POC) studies at a very early stage of drug development is becoming increasingly important.

A POC study is a milestone in drug development

POC studies are especially designed to provide preliminary evidence of efficacy and safety and their measures, with the aim to decide about proceeding into full development of the drug or not. This decision is often based on whether or not a required effect size can be detected in a POC study in comparison to placebo or a comparator treatment.

Each POC study should be as small as possible but at the same time the number of study subjects should be large enough for the detection of any drug effects.

The sample size is usually determined by the primary objective of the trial and sometimes in dose-ranging POC studies also by a secondary objective to explore a dose-response relation.

Above all, a POC study is a milestone in drug development because it is crucial for the “go – no go” decision. Thus, it is a critical step towards future marketing of a viable human therapeutic. However, each POC study presents unique challenges in both, design and conduct.

CRS’ Medical Affairs group assists you to ensure we find the ideal design to meet your objectives.

CRS Group Proof of concept

Each POC study presents unique challenges in both, design and conduct.

CRS will perform your POC study succesfully

CRS is the partner at your side with the proficiency and skills, expertise and experience to design and perform your POC study successfully on time and within the budget. With the support of CRS experts in regulatory, bioanalytics and biostatistics and with our medical writing teams, you can trust us with all your particular POC studies. Working with CRS experts is vital for the success of your Phase I/II clinical trial program. We have designed and conducted numbers of First-in-Human (FiH) and stand-alone POC clinical trials.

CRS´ continuously trained clinical teams realize the endpoints in a consistent manner to accomplish both, objective and subjective POC study tests in exactly the same way.

CRS routinely performs POC clinical research in healthy volunteers and also in a wide range of patient populations. For some indications, we can recruit a large number of patients (i.e., more than 50 patients in areas like diabetes, obesity, and Non-Alcoholic Steatohepatitis – NASH / Non-Alcoholic Fatty Liver Disease – NAFLD), while in other indications we cooperate with partner Contract Research Organizations (CROs).