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STUDY MONITORING

Donawa Lifescience Consulting clinical research associates (CRAs) are selected based on a high level of expertise. Each CRA operates in accordance with DLC standard operating procedures (SOPs) specifically based on pharmaceutical or medical device requirements. This allows them to efficiently assist the sites and sponsor in complying with all applicable European and, when requested, US, clinical study requirements.

For large multi-center studies, DLC project mangers are available to supervise and coordinate monitoring activities. Our monitors and project managers have open access to our team of medical and regulatory affairs experts throughout the project, so that any technical or clinical question or issue can be addressed in a timely and effective fashion.

DLC monitoring services include:

• Site initiation visits
• Routine monitoring visits
• Site close-out visits
• Site personnel and facility evaluation
• Verification of investigator study files and patient informed consent
• CRF review/source document verification
• Hospital equipment/instrument verification
• Protocol violation/deviation reports
• Monitoring of adverse event reporting
• Site support: Routine telephone, e-mail contact, monthly reports
• Assistance to investigators in preparing required reports for the Ethics Committee

Please contact us for further information or assistance.