CTI's Medical Writing team is comprised of experienced individuals with advanced degrees including PharmDs, MDs, and PhDs. Our medical writers work routinely with our functional departments to ensure regulatory documents are developed to be scientifically, methodologically, and operationally sound.
CTI has continued proven success in numerous approved drug and device applications. We regularly prepare international regulatory submissions, including:
Serial submissions to the IND include but are not limited to:
CTI routinely prepares Clinical Study Reports (CSRs) as part of our work for our sponsors. We work closely with sponsors to ensure accurate data presentation and interpretation, strict adherence to regulatory guidelines, and sponsor requirements.
Our group of medical writers and research scientists will quickly analyze data and present it in a meaningful way, ensuring a high quality study report. We have an independent Quality Assurance team that ensures quality is the leading factor in all of our services and is reflected in all of our submissions to regulatory authorities.