Services | Study monitoring

Our CRAs work closely with the project leader to ensure that comprehensive planning, communication plans and project activities are documented in detail. They are always focused on the protection of the rights and the safety of all subjects involved in clinical investigations and in the quality and integrity of the resulting data submitted.

In order to accomplish the project expectations (careful and efficient country and site selection) we need to have a good picture of the recruitment potential. In collaboration with the Sponsor's plan, we carry out feasibility studies in close cooperation with our international network of reliable investigators. Working with realistic information will help us achieve the timelines set within the estimated costs.

The next step after the feasibility study is to finalize the strategy to follow considering the clinical protocol and define the participating countries and sites. We count with an extensive and updated database of potential sites and investigators in Latin America. We also consider the results obtained from previous studies. We are open to any suggestion on the site/investigator list.

Starting from the feasibility period, we develop a strategy of patients’ recruitment in cooperation both with sponsor and investigators.

KLIXAR is able to assess capabilities and limitations of each site and execute action plans to help them return to the recruitment rate expected. We are aware of the importance of patients retention in the studies, especially the long-term ones. We are prepared to deliver appropriate individualized training and educational programs for investigational teams.

The industry has been evolving from site monitoring to site management and KLIXAR can not be outside of these changes. Site management is more than the mere contact with the site and monitoring activities. The monitor needs to feel part of the site staff without loosing perspective. Needs to help the investigators in improving their performance and KLIXAR works under this concept. This builds a long-term relationship with our investigators that benefits the development of the studies.