Sub Services
Site Initiation Visits (SIVs)
Conducting site initiation visits to ensure that trial sites are fully prepared to begin the study, providing necessary training and resources. SIVs involve reviewing study protocols, data collection procedures, and regulatory requirements with site staff, ensuring they understand their responsibilities and are equipped to conduct the trial effectively.
Routine Monitoring Visits (RMVs)
Performing regular monitoring visits to assess site performance, verify data accuracy, and ensure compliance with study protocols and regulatory guidelines. During RMVs, CRAs review source documents, data entries, and informed consent forms to ensure data integrity and participant safety. These visits also provide an opportunity to address site challenges and offer ongoing support and training.
Data Verification and Source Data Review
Ensuring the accuracy and completeness of trial data through meticulous source data verification and review. This process involves cross-referencing data entries with original source documents to confirm consistency and validity, ensuring that trial data meet the highest standards of quality.
Protocol Adherence Monitoring
Monitoring adherence to study protocols, identifying deviations, and implementing corrective actions to maintain trial integrity. CRAs ensure that all trial activities align with the approved protocol, addressing any deviations promptly to prevent impacts on data quality or participant safety.
Safety Monitoring and Reporting
Overseeing participant safety by monitoring adverse events and ensuring timely and accurate reporting to regulatory bodies. Safety monitoring involves assessing the occurrence and severity of adverse events, facilitating rapid communication and response to ensure the well-being of participants.
Close-Out Visits
Conducting close-out visits to ensure that trial sites appropriately conclude study activities and comply with all regulatory requirements. Close-out visits involve final data reviews, resolution of outstanding issues, and retrieval of study materials, ensuring a smooth and compliant study closure.
Communication and Collaboration with Sites
Maintaining open lines of communication with trial sites to foster collaboration and address any issues or concerns promptly. Regular communication ensures that sites receive the support and guidance needed to conduct the trial effectively and maintain compliance with study requirements.
Regulatory Compliance Verification
Ensuring that all trial activities adhere to regulatory standards and guidelines, minimizing risks of non-compliance. CRAs verify that sites follow applicable regulations, such as Good Clinical Practice (GCP), and implement any necessary corrective actions to maintain compliance.