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Wether your trial involves medical devices, pharmaceuticals,
or nutritional supplements: Amantec will implement your
clinical studies quickly, economically, and efficiently.
See our expertise for yourself, and make use of our
comprehensive range of services. |
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Concept and planning |
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- Protocol preparation and review
- Budgeting of clinical studies
- Preparation of study plan and all study-related documents
(incl. CRF, patient information, investigator study files, etc.)
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| Quality |
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Range of indications |
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| Study organization |
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- Selection of suitable study centers (e.g. hospitals,
specialized practices)
- Selection of the principal investigator of the clinical study
in accordance with German Drug Law
- Coordination of all outside participating companies
- Reporting to authorities (Federal Institute for Drugs and
Medical Devices, ethics committees, regional boards, etc.)
- Contract preparation for study physicians
- Physician support and training
- Provision of test samples and study materials for the centers
- Implementation of the study within the study centers'
routine procedures
- Study and investigator meeting planning
- Communication between sponsors and study centers
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| Study implementation |
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- Study management (selection of suitable biometrics, data
management, laboratory equipment, Phase I equipment, etc.)
- Monitoring of centers from opening to closing
- Study and legal parameter supervision (ICH-GCP, German
Drug Law, Medical Products Law, etc.)
- Document management (TMF filing from the beginning of the
study through archiving)
- Processing and forwarding of severe adverse events (SAE)
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| Results and analysis |
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- Preparation of all documentation related to the study,
including newsletters, reports, tracking lists, etc.
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| Additional services |
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- Personnel support at your company
- Study-specific provision of project management software
(EasyClin)
- GCP training for study physicians and study teams
- Co-monitoring of large (inter)national studies
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| Copyright © 2007 by AMANTEC |
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