Are you preparing to undertake a clinical trial in Europe? Do you need help with investigator or site selection? Do you know what Ethics Committee and Competent Authority approvals your study will require?
Our clinical division based in Germany has expertise setting up, conducting, and reporting clinical trials designed for:
Our clinical team will support you in designing your clinical study with appropriate study endpoints, help determine the optimal cohort sample size, study, and follow-up duration, and evaluate the parameters to be collected against the desired evidence to be gained. Furthermore, we support site selection by screening through objective criteria, managing the clinical study sites as necessary, and drafting the study report per the required template and content.
Emergo will work with you to ensure the accuracy and consistency of data collection during the trial and assure the safety of patients, which are your primary responsibilities as clinical trial sponsor. In addition, our project management team is committed to meeting the non-clinical goals of the study, such as staying within budget, meeting projected timelines, and, if necessary, adapting to protocol changes. Our team members are experienced in clinical studies with medical devices and have been fully trained in ISO 14155/GCP. Our project management and monitoring services include, but are not limited to:
We have the necessary skillsets to design and run studies, and use the results according to the requirements defined by your company’s plans in the most cost- and time-efficient way possible. To facilitate management, our clinical consulting team has native-level English, Dutch, German, and French speakers, and covers Italian and Spanish jurisdictions. Here’s how we can help:
Our team expertise covers a wide range of devices and study types, including but not limited to FIM studies, prospective CE Marking RCT (blinded or not), and Post-Marketing Clinical Follow Up (PMCF) studies. Under the MDR, the latter will be mandatory in an ever-wider scope of products, with similar initiatives emerging in the US (Real Life Data) and Japan.