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Expertise in medical and pharmaceutical decision making

The SAM GmbH is an internationally active contract research organization (CRO), since 2014 ISO 9001:2008 certified and “Gold Member” of the CDISC community..

SAM GmbH offers full service in planning, implementation and evaluation of clinical trials of phases I-IV and non-interventional studies.

ICH / GCP guidelines define the services of the SAM GmbH. They run under their own SOPs or SOPs of a sponsor of the highest quality.

Many years of experience in the therapeutic areas, cardiovascular, dermatology / allergy, ophthalmology, rheumatology, orthopaedics, urology, oncology, pain management, gastroenterology, nephrology, pulmonology, infectious therapy, gynaecology and neurology / psychiatry, as well as excellent contacts with outstanding scientific investigators with many years of membership in medical societies complete the profile of the SAM GmbH.

Developed by SAM GmbH, the Remote Data Entry (RDE) system ars ® is self-explanatory to the investigators, patients, monitors, data managers, pharmacovigilance staff and field staff. It enables the direct computer-aided collection of data, plausibility checked, by the investigator, the study nurse or the patient. The data are immediately readable for monitors, project managers, data managers, pharmacovigilance staff and field staff.

Data collection is carried out SSL coded over the internet so that the data is available to the investigator, the study nurse or the patient immediately after entry for further monitoring by the monitors, the data managers or the pharmacovigilance staff. Data security is ensured by SSL encryption according to the latest safety standards.

Duration and costs of clinical trials and NIS (non-interventional studies) are reduced by the use of ars ®, i.e. when using our eCRF compared to clinical trials and NIS with paper CRF, costs and duration are reduced by up to 40 %.