Monitoring activities conducted by Clinical Research Associates (CRA) are regarded as one of the most important part in the conduct of a new drug development. Linical CRAs are skilled and well trained to ensure a highest quality review of your study data and to interact effectively with the study sites.
Being the main communication link between site and study sponsor the main tasks of Linical CRAs during a clinical study site visit are:
- Establishing a clear, individual and well-structured communication to the site
- Ensuring the regulatory compliance of study sites
- Overseeing the process of data collection
- Verification of source documents and case report forms
- Resolving of queries
Linical is committed to highest quality and subsequently has implemented ongoing co-monitoring and accompanied visits by a dedicated trainer and senior staff for their CRAs in order to ensure compliance with local laws and international regulations and guidelines. Using a defined process we are able to identify potential issues in a timely manner and support our CRAs with their skills and professional development.
Our highly motivated and educated CRA team guarantee reliable data for your new drug submission.