Clinical Research: Late Stage Development - read more
AMS is your experienced partner for PASS, PAES, Registries, RCT, and Patient Reported Outcomes Research. AMS NIS-specialists give advice in NIS-rationale and Observational Plan set-up, making sure:
- NIS rationale fits existing and future legal expectations
- NIS concepts ideally support Medical Affairs‘ responsibilities and targets
Epidemiologic services at AMS include observational studies of risk factors, drug utilizations and adherence, Clinical Safety, comorbidities, and natural history of disease.
AMS assists you in evaluating the most appropriate study type for the design of your study.
For non-interventional studies:
- Regulatory requirements within the EU are quite complex - AMS Regulatory Affairs team has experience with national, European and international studies and guides you through the approval and notification requirements, including registering your study and its results in public registries,
- performing applications to regulatory authorities and data protection agencies as well as notifications to competent authorities or health insurance companies (if needed), and
- Submission to the Ethics Committee: AMS supports you in selecting the main Ethics Committee and supports your sites in submitting to their local Ethics Committee
- Data protection is one of the most challenging topics and our data protection officers are fully aware of the current requirements for study documents.
Moreover, AMS well-trained project managers can support in preparation and conduct of site audits – whether intended by you or competent authorities.