Clinical Monitoring

We make sure that all applicable rules and regulations, including the ones derived from Good Clinical Practice (GCP) are embedded in our clinical monitoring services. Our CRAs are trained in all changes in rules and regulations, supported by our presence in 24 countries throughout Europe. Changes are directly implemented through training and updating of our Standard Operating Procedures (SOPs). Frequent audits of our monitoring activities are performed for consistency and adherence.

 

Flexibility and good fellowship are two main qualities we appreciate in our monitoring teams. Our CRAs are in close contact with our investigators, in many cases fellow physicians, and have established good collaboration over time.

 

Our well trained CRAs, all with a (bio)medical background, including 30% MDs, quickly comprehend the diverse clinical conditions in any therapeutic area. The excellent team spirit of our CRAs raises on-the-job training efficiency and the level of skill-sharing, optimizing the learning curve. Furthermore, our CRAs operate in close harmony with our large, all MD, medical division. This enables our CRAs to monitor clinical data precisely and to the point, and to guide site personnel in correct reporting thereof.

 

Timely collection, an optimal quality of study data and clear event documentation is our motto. 

Due to our easy and accessible organizational structure and through regular contacts between CRAs and project managers, a high level of efficiency is reached and opportunities are not missed. In addition, we make certain that the same staff will remain on the job from start to finish of each trial guaranteeing an efficient, speedy process and clear results.

 

CRAs and study managers are located in each European country with investigational sites. Laws and regulations but also local customs are therefore well known by our local staff and will at all times be taken into account and respected. Being located in many European countries, we can manage multinational trials in over 1000 sites.

 

Our long-standing experience with quality and output of institutional research teams throughout Europe ensures that feasibility analysis can be done quickly and with reliable results. Sticares InterACT cooperates with all major regional and national regulatory agencies in Europe. Local knowledge of the regulatory issues is vital and warrants a correct and timely submission of your trials.

 

Our CRAs have long-term personal contacts with our investigators. As a result, our investigators are willing to make that extra effort for your trial, securing on-time enrolment and enabling rapid verification of trial data by our CRAs.

 

Sticares InterACT has an extremely low staff turnover. The number of trials per project team member is limited to maintain the high level of attention needed for your trial.