Clinical trial monitoring is the act of overseeing the progress of a clinical trial, ensuring that it is conducted, recorded and reported in accordance with the study protocol, applicable Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the relevant regulatory requirements.
TechnoSTAT’s skilled clinical research associates (CRAs) ensure the highest quality of data review combined with effective communication with study sites both in Israel and abroad.
Our CRAs conduct on-site monitoring visits throughout the study to:
- Oversee data collection.
- Oversee subject enrollment and ensure that informed consent is properly obtained and documented.
- Assess eligibility of potential subjects through methods such as screening interviews, review of medical records and discussions with physicians and nurses.
- Maintain required records of study activity including case report forms (CRFs), drug dispensation records and regulatory forms.
- Review source documentation (SDV).
- Review case report forms (CRFs).
- Ensure regulatory and protocol compliance, while reducing protocol deviations.
- Resolve data queries.
- Communicate with laboratories or investigators regarding laboratory findings.
- Manage drugs or devices necessary for study completion.
- Conduct interim analyses as requested by clients.
As your CRO, TechnoSTAT will manage the conduct of your trial to ensure proper clinical activities throughout the study.