Our Services and Methodology
We provide standard operating procedure (SOP)–guided study monitoring, auditing, and quality assurance support for all phases and inpatient/outpatient studies at over 50 clinical sites for the biopharmaceutical industry and the National Institutes of Health. Our dedicated in-house contract monitors are Certified Clinical Research Associates (CCRAs) through the Association of Clinical Research Professionals. They review regulatory and ICH Good Clinical Practice compliance and adherence to the protocol, and they ensure the data’s quality and the completeness of study participants’ follow-up information. Our monitors are experienced in a wide variety of therapeutic areas and all study phases. They are skilled in applying our SOPs for site initiation and training, recruitment and screening, forms, process and intervention monitoring, and source data verification. Since site monitoring and source document verification account for 15% to 30% of clinical trial costs, we also offer our clients a streamlined risk-based monitoring approach through central data monitoring.
Work with us. Contact us to learn how we can find the right solutions for all of your clinical research needs.