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.

Click here for an overview of our drug safety services:

EMA Pharmacovigilance
Health care studies
Observational studies
EMA Pharmacovigilance
Medical Biometrics
Approval of Medical Devices
Clinical Investigators
Clinical Trials
GCP Legislation
GCP - Good Clinical Practice
GCP Guidelines
GCP Compliance
Clinical Research Organisation
Contract Research Organisation
Pharmacoeconomics, Health
Pharmacoeconomic studies
Patient Monitoring
Monitoring Clinical Trials
Clinical Monitor
Marketing Authorisation
Medicinal Product Approval
Drug safety
Data management plan
Clinical development
Monitoring investigators
Non-interventional studies (NIS)
Patient recruitment
Phase IV studies
Investigator audit
Investigator qualification
Investigator selection

EMA Pharmacovigilance · Health care studies · Observational studies · EMA Pharmacovigilance · Medical Biometrics · Approval of Medical Devices · Pharmacovigilance · Clinical Investigators · Clinical Trials · GCP Legislation · GCP - Good Clinical Practice · ICH GCP E6 · GCP Guidelines · GCP Compliance · BfArM GCP · Clinical Research Organisation · Contract Research Organisation · PSUR · PSURs · Pharmacoeconomics, Health · Pharmacoeconomic studies · Pharmacoeconomics · Patient Monitoring · Monitoring Clinical Trials · Clinical Monitor · Marketing Authorisation · Medicinal Product Approval · Drug safety · Data management plan · Clinical development · Monitoring investigators · Non-interventional studies (NIS) · Patient recruitment · Phase IV studies · Investigator audit · Investigator qualification · Investigator selection