We have the experience to perform complex trials from the set up to the close out visits, including regulatory submissions, insurance and site contract management.
Clinical trial set up
Identification of principal investigators that ensures an adequate quality and recruitment expectations is one of the key aspects in success of the trial. Therefore our data base and experience mitigates the lack of quality and poor recruitment figures.
At Clina we have the expertise to provide insights and strategical thinking in the regulatory process and perform the submissions. We work very close with the Ethical Committees and our National Competent Authority. This fact brings the opportunity to set up meetings or forward queries before the submission which decrease the number of questions/rectifications during the evaluations. We are experts in GCP, Investigational medicinal products and medical devices.
We believe that the monitors are an essential actors in the process and therefore must have critical thinking. and must see patient`s data from a holistic point of view. Clina´s monitors are highly qualified professionals that have the right skills to ensure an adequate site management and data integrity. They have compliance mindset and are client oriented and committed with their mission. Our monitoring reports contain high level details and relevant information which provides the client with an accurate picture of the site status.