We provides field monitoring, site management and administration services in Poland. Routine monitoring is performed accordingly to ICH GCP rules, FDA guidelines and local regulatory requirements.
Monitoring activities include:
Site staff training
Protocol compliance control
Remote monitoring in EDC studies
Documentation maintenance and update
Regular contacts with sites between on site visits
Drug inventory and accountability
Source Data Verification (100%)
Regulatory requirements compliance control
Our CRAs are professionals with life sciences, medical or pharmaceutical background.
They are located in strategic cities of the country. All CRAs undergo regular intensive training designed exclusively for their individual needs, and experience. Clinical Development Training Programs are prepared in cooperation with training specialized providers.
Clinical Consulting Company commits to provide sponsor with highly qualified regional based Clinical Research Associates which substantially reduces the overall cost of the project and ensures its timely completion.
Clinical Consulting CRA-s
perform comprehensive site management and monitoring activities to include the following types of monitoring visits:
Pre study qualification visits
Interim monitoring visits
Close out visits
All activities are performed in accordance with ICH-GCP to ensure all investigational sites are compliant with all applicable regulations and protocol requirements.
In addition to on-site responsibilities each CRA is responsible for site management documentation and follow-up activities to ensure that site staff remains motivated and focused.
In summary the Clinical Consulting CRA-s play a major role in the successful conduct of a study.
The relationship developed between the CRA and the site staff is such that there is a focus on open effective communication with the CRA providing training and support thus ensuring patient safety, data quality and maximizing patient enrolment.
Sites qualification – sites selection and feasibility
Clinical Consulting Company
has long-standing relationships with these researchers, who consistently exceed expectations for subjects recruitment, data quality, and timelines while maintaining a patient-centric approach.
Investigator site selection
is a critical element of a successful clinical trial.