LITERO supports you in developing your clinical strategy and validating your claims and offers the compilation of the Clinical Evaluation Plan and Clinical Evaluation Report and-if required-the SSCP in order to disclose the benefit-risk ratio of your device and to define measures to keep this ratio positive and acceptable.
In order to actively gather information from post-market surveillance we will prepare and continuously update your PMS Plan as well as summarise the results and the conclusions of the benefit-risk determination in the PMS Report or PSUR. We support you in specification your PMCF activities and document the results in a PMCF Report.
Our service for literature monitoring offers regular monthly literature search for your device in widely used reference databases (e.g. Medline, Embase).
LITERO supports your signal management process by periodic monitoring of sources like spontaneous reports, clinical studies and scientific literature and provides you with validation of all reports of suspected adverse reactions and submission to the competent authority (as ICSR or SUSAR). We complete your DSUR with safety information from all ongoing clinical trials and your PSUR in the framework of the post-authorisation evaluation.
As the scientific literature is a significant source for monitoring of safety profile and assessment of the benefit-risk ratio, we offer you service for regular weekly searches in reference databases suitable for your medicinal products.
We support you in preparation and review of clinical documents, marketing and educational materials based on study reports and medical/scientific literature.
LITERO GmbH - Clinical affairs and vigilance
LITERO GmbH provides a wide range of services in the areas of clinical affairs, post-market surveillance and pharmacovigilance for the pharma and medical devices industry.
With almost two decades of experience, we deliver high-quality solutions for your individual tasks.
Our mission is to gain a deep understanding of your product and develop your clinical strategy to provide you with full scientific, clinical and post-market surveillance support along the product lifecycle, from definition of claims within product development to preparation of clinical and pharmacovigilance documentation in the context of regulatory approval and during post-marketing.
Our values are quality, responsibility, creativity, and transparency. These values drive our daily work, the way we meet challenges and the way we interact with our clients.
Why LITERO? Because there’s science behind it!