Professional documentation services that guarantee the compliance of your protocols, informed consent forms, and clinical study reports with the regulatory standards. Thus, facilitating the submission to health authorities without any hassle.
Professional statistical help that consists of: justification of sample size, planning of randomization, and thorough statistical reporting that is resistant to the scrutiny of regulators.
Strong systems and protocols to maintain the integrity of the data during the entire lifecycle of your trial, from planning the initial collection to locking the database and transferring the final data.
complete management of operational tasks that includes identifying and activating sites, regulatory submissions, monitoring activities, and daily coordination of the project to ensure your trial stays on schedule.
Systems for monitoring and reporting of safety that facilitate the prompt identification, evaluation, and reporting of adverse events to both local and international authorities in compliance with their respective requirements.
Independent quality control through regular audits, qualification processes, and compliance checks, which recognize and rectify potential problems before they affect your study.
Commercial strategies based on evidence that convert clinical research results into medical education and marketing initiatives effectively complying with regulatory and ethical standards.
Dedicated site support services optimizing investigator performance through training, patient recruitment assistance, and operational coordination across multiple study locations.