Clinical and Safety

Selection and management of an appropriate CRO is critical to clinical trial progress. Our Clinical Operations staff ensure reliable communication between the Sponsor and CRO, accurate site feasibility assessments, and effective patient recruitment and data collection. By enhancing communication with your clinical sites and holding your CRO accountable, our team will ensure accurate and on-time delivery of your clinical data. 

Medical expertise in your therapeutic indication can provide your organization with effective assessment of eligibility and enrollment-related issues, oversight of serious adverse event (SAE) reporting, and narrative review for accuracy in attribution, expectedness, and severity. Our team will drive the development of your clinical study protocol, and can enhance your interactions with Key Opinion Leaders  and Investigators. Our medical and safety team members will work to foster consensus during safety meetings and ensure accurate presentation of clinical data within regulatory filings.