We are aware that efficient site selection is the first crucial factor for the success of a clinical trial. In this respect, efficiency, defined as the optimal combination of quality and promptness, is of huge importance.

The rapid start-up of a clinical trial therefore depends on proficient consulting with regard to the clinical trial agreements. Additionally, the prompt expert application to ethics committees and competent authorities is also the key. We also guarantee the prompt handling of required application documents (incl. the Austrian application form for initial submission), the annual renewal of the ethics committees’ approvals and any other submissions that may be required throughout the duration of the trial.

The term ‘monitor’ no longer covers the entire range of activities associated with the growing demands on clinical trials. It is therefore with good reason that the term "site manager" has become established in recent years. Although the sites are mostly well prepared, the organisational skills of monitors are still highly welcome in the management of the site and the trial. The availability of well supported and trained study staff is another key to the success of the respective trial.

In order to meet all requirements, we provide well trained and experienced site managers.

The following services are provided:

• Feasibility
• Site selection
• Consulting in contracting
• Submissions to ethics committees
• Submissions to competent authorities
• Training of site and sponsor staff
• Monitoring and site management: initiation, monitoring and close-out visits
• Project management
• Set-up, maintenance and adequate storage of Trial Master Files

As a full-service CRO, we also offer our services for Investigator Sponsored Studies (ISS).