AMS has extensive experience in the planning, execution, evaluation and reporting of Post-Marketing Surveillance (PMS) studies. Another focus of our activities is the establishment and maintenance of national and international Registry studies. Our projects in this area have already been running for up to seven years.

Over the last few years we have carried out over 100 projects in a wide choice of indications and using a variety of scientific approaches. The number of study centers involved ranges between ten and 7000, the number of documented patients from 78 to 30,000. As well as conventional paper documentation, we also increasingly use electronic data capture.

An overview of what we offer:

• Medical and biometric advice
• Creation of study documents including the data validation plans (DVP) and statistical analysis plan
• Project management
• Notifications as required by Germany's Drugs Act (AMG) § 67 (6)
• Establishment of the project database
• Training of field staff
• Center selection / allocation (with or without sponsor field staff involvement)
• Status reports (available online or via mail)
• Monitoring (particularly of registration-related projects)
• Handling of AEs / SAEs
• Data entry (including Optical Character Recognition or Electronic Data Capture)
• Data management
• Investigator fees
• Codification (e.g. using the Medical Dictionary for Regulatory Activities, MedDRA)
• Biometric evaluation
• Authoring of concluding reports
• Creation of publications, posters and presentations
• Quality Assurance throughout studies
• Audits (including external projects)

 

We understand your needs, and turn them into tangible projects!