We offer a full service profile for Phase I clinical trials. We provide novel and proven concepts for carrying out your study and guarantee its long-term supervision. As Phase I clinical trials have a high regulatory impact our regulatory team is familiar with all legal/ICH-GCP guidelines and other regulations or guidelines as well as the respective practices. Thus our team ensures a successful and timely study design and set-up. Set-up starts with the preparation of essential documents and identification of trial sites and the submission of documents to ethic committees and regulatory authorities, while also making sure all boards and committees are in place to guarantee patient safety and regulaotry compliance.Based on the inherent safety risk in Phase I trials, our monitors are sensitized and trained to adequatly monitor sites. All three monitoring strategies (on-site, online and central) are widely used and supplemented by the “risk-based-monitoring” method.
Aiming for the determination of the maximum tolerated dose (MTD) the activities of the Safety & Pharmacovigilance department play a special role during Phase I clinical trials. We guarantee a fast intercentric transfer of information. In addition to the Data and Safety Monitoring Board (DSMB), Phase I clinical trials are monitored by a body called Safety Review Committee (SRC) to ensure higher quality and safety of the study as a whole. And most importantly, the trial is executed according to time and budget to achieve the right safety signals.