We offer companies in the pharmaceutical and medical device industries comprehensive support in all aspects of product development and positioning, based on decades of clinical and scientific experience in allergology and infectious diseases of the respiratory tract and head and neck region.
We support companies in preparing and providing scientific advice to regulatory agencies and in submitting study applications to authorities. The topic of PIP (pediatric investigational plan) is a focus of our expertise.
The application and implementation of ICH-GCP is the common thread in all our activities.
Within the framework of our ISO-9001-certified quality management system, we have qualified auditors who also carry out external audits if required.
With more than 100 studies that we have responsibly conducted or accompanied, we have extensive experience and sufficient capacity in project management.
Thanks to our cooperation with a network of study centres that has grown over decades of experience, we have the capacity to recruit large patient collectives in a timely manner, even for pivotal phase III studies.
We have our own team of scientifically trained clinical monitors with extensive experience in monitoring phase I to III, non-interventional and medical-device studies in the numerous centres of our network.
Our team of data managers successfully uses modern tools such as ePRO and EDC systems for the rapid and GCP-compliant collection and processing of study data.
A team of biometricians and epidemiologists, some with a clinical background, is available for all questions of study-related data analysis, randomisation and sample size estimation.
GCP-compliant archiving of research data including long-term backup is part of our service portfolio.
With our own scientifically or medically trained experts, we also support the sponsor’s pharmacovigilance officers in issues such as CIOMS and reconciliation.
Our medical writing team of PhD scientists with extensive publication experience supports project teams and sponsors in the preparation of essential documents from synopsis to ICH report and in the drafting, submission, rebuttal and placement of manuscripts in high-ranking journals.