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Legal Framework
Post Marketing Surveillance Studies (Post Authorization Safety Studies) are defined and settled by the Notice to Applicants NTA III/5944/94. These few regulations together with various publications open a wide range for the conduct, not so much in the regulatory area but in the quality of planning and perfomance of such studies.
Coming from the serious side of clinical trials we try to adopt quality rules and procedures of research to PASS without ignoring marketing needs and goals. We provide full service from planning to report/publication as well as partial service.
The field phase of the PMS/PASS may be conducted by the sponsor's own sales representatives with VIMTA acting in the background, or sites may be selected, contacted and monitored by VIMTA staff.
Three main advantages we are able to offer:
- marketing-experienced consultants and sales professionals help with the planning of your project
- our quality standards are based on our experience in clinical research
- each single case is checked for validity by a physician
For our information brochure with a detailed description of our standards and services or for obtaining information concerning your planned project please, feel free to contact us at
clin-res@vimta.com |
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