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.
Find out, how AMS Clinical Research services fit to your needs:
Talk or write to us:
AMS Clinical Research Teams & Indications
Indication-specialized teams will take care:
As part of the AMS company philosophy, indication-specialized teams are set up to strengthen special therapeutic experience across all areas of the Clinical Research services provided.
The AMS Clinical Research team includes experienced physicians who continuously support all projects in multiple aspects of project performance, such as:
- Clinical trial design
- Protocol set-up
- Site and patient selection
- Medical review
- Medical input to final report
Our specialized teams have broad experience in various specific indications from a large number of trials conducted at AMS. To ensure the most recent and in-depth knowledge of highly specific indications and study procedures, our study teams and clinical research associates are regularly trained.
Please find AMS' Clinical Research Indication Experience here.
Get in touch with us at:
Your direct Contact:
Kathryn Hutchinson
Director Regulatory Affairs
Harald Wagner
Director Clinical Operations
Antje Dombrowski
Director Clinical Operations
Rolf-Dietrich Tiemann
Director Biostatistics and Data Management
Hassan Kazerooni
Director Data Management
Dr. med. Kerstin Döpfner-Ozean
Director Clinical Safety
Dr. rer. nat. Hanna Neymeyer
Director Medical Writing
