We have a team of CRAs who have exceptionally strong monitoring skills, producing timely and quality monitoring reports. Our monitors have a broad and robust therapeutic area experience and a wealth of clinical trial knowledge, with many having worked for pharmaceutical and medical device companies as well as other CROs. Their background and experience allows them to support the project leaders, and build solid relationships with Investigators and site staff. Importantly we recognise the need to provide a credible, professional and positive impression on behalf of our Customers.
All CRAs and Senior CRAs are accustomed to monitoring clinical trials for US and European based companies, with data being submitted to the FDA and European authorities, as well as local regulatory agencies.
They are knowledgeable and experienced with all aspects of study site management and monitoring according to ICH GCP guidelines. This includes site start up activities, essential document generation, ethics committee applications, facilitating Investigator meetings, site Initiations, GCP training, monitoring, site close out and data query resolution.
Most of our Senior CRA’s have extensive experience in Phase 1 trials having monitored many early phase studies.