CLINICAL MONITORING

As with our Project Managers, Southern Star Research has some of the most experienced Clinical Research Associates (CRAs) in Australia. We have a team of CRAs who have have a broad and robust therapeutic area experience and a wealth of clinical trial knowledge, with many having worked for global pharmaceutical and medical device companies as well as other CROs.

Their background and experience allows them to support the project managers, and leverage established relationships with Investigators and site staff to ensure study goals are met successfully. Importantly we recognise that CRAs are also ‘Study Ambassadors’ and need to provide a credible, professional and positive impression on behalf of our clients.

Our CRAs have in-depth knowledge of ICH-GCP guidelines, and are acutely accustomed to monitoring clinical trials to the high standards required for submission to regulators such as the US FDA and EMA.

Our CRAs have expertise in site start up activities, essential document generation, ethics committee applications, facilitating Investigator meetings, site Initiations, GCP training, data query resolution, remote eDC review, along with having exceptionally strong monitoring skills, producing timely and high quality monitoring reports.

Southern Star Research is also extremely proud to have a strong staff retention rate which is well above the industry standard, and we feel it acts as testament to the relationship we have with our staff.