Our Services and Methodology
One of the major functions of our coordination activities is quality assurance. We have found in multi-site trials that it is crucial to pay attention to how each site is conducting the study, whether operational procedures are deviating from the protocol, and, if so, what the impact will be on the data. Within the project management plan, we develop a quality control plan that includes risk management and serious breach reporting. We customize our standard operating procedures to explain the conditions and flow of reporting issues to the sponsor. We validate data management systems, tables, and listings and audit study forms against protocol requirements and study databases. Our long experience in validating clinical studies has allowed us to strengthen internal procedures to maximize accountability, systematic feedback, and quality control in all aspects of studies and data handling.
In addition, we have developed quality management systems for clinical researchers based on their individual compliance needs. We conduct assessments of current compliance levels and create corrective action plans.
We carry out onsite assessment of researchers’ regulatory risks to GCP/ICH, HIPAA, and Part 11. We can then assist in writing policies and procedures and in developing and delivering training to ensure effective quality system implementation.
Work with us. Contact us to learn how we can find the right solutions for all of your clinical research needs.