SERVICES
Data Management
Our data services involves entering, reviewing, and managing all clinical trial data to ensure the accuracy and integrity according to the protocol while maintaining the confidentiality of study and patient information. This task includes query management. With being well versed in multiple eDC and CTMS platforms, we can easily adapt to what the project requires.
Quality Assurance
Being one of the most important aspects of running trials, we can assist sites maintain high standards of quality throughout the research process in order to not only safeguard participant safety, but to ensure proper reporting of study data.
Monitoring Support
We understand how stressful it can be to manage study patients, as well as, making time to address concerns of a monitor visit (IMV). We will aid in addressing all data and source related action items identified in the IMV.
Source Creation
This service includes designing CRFs and other detailed protocol-specific source documents that ensures accurate and consistent data entry. We will communicate and collaborate with sponsors, CROs, and regulatory personnel to confirm that all information is captured systematically and complies with regulatory standards.
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Concomitant Medications Review
This review is crucial for understanding potential drug interactions, assessing the impact on the study's outcomes, and ensuring patient safety. The process includes thorough cross-checking of patient's medical history, adverse events, drug accountability, verifying doses, and durations.
Adverse Event (AE) Review
We would complete review and follow up of AEs, which includes SAEs and AESIs. This comprehensive review process will assist in prompt and precise reporting, which will ensure a smooth monitor visits and sponsor audits.