Monitoring drug safety
After approval of a medical device, legislators require extensive measures for continuous monitoring of the safety of the drug. Dr. Oestreich + Partner has an expert staff with international experience in drug safety who provide high-quality documentation and analysis for benefit/risk assessment of the pharmaceutical products. We offer our clients needs-based project planning for drug safety. Our team, made up of experts from a wide range of fields in clinical research, provide extensive and bundled expertise in both medical and technical areas.
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Intelligent drug safety documentation systems
A particular focus in the documentation of drug safety is the creation of periodic safety update reports (PSURs), which provide information on experience with a drug for further international research. Dr. Oestreich + Partner takes over the professional preparation of these reports for its clients. With our Internet-based programs PMSBOX and OPVERDI, all authorized project staff members have password-protected access to all relevant study data at any time. Our software solutions are highly sensitive to all regulatory requirements and can be individually adapted to your queries. The professional data reliability of OPVERDI and PMSBOX enables simple error prevention and error correction as well as intelligent coding for data security – for the protection of patients. In addition to PSURs, in collaboration with partners we offer packaging and labeling as well as storage and shipping of medication and devices for clinical testing. Upon request we also carry out randomization and provide emergency envelopes. A 24-hour hotline is available for emergency decoding and reporting adverse events. We also supply telemedical devices for monitoring of drug safety.
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