Observational studies

Post Marketing Surveillance (PMS), Non-Interventional Studies (NIS), Post-Authorisation Safety Studies (PASS)

For phase I to IV clinical trials and for observational studies, like Post Marketing Surveillance (PMS), Non-Interventional Studies (NIS), Post-Authorisation Safety Studies (PASS), Dr. Oestreich + Partner GmbH provides its own proprietary EDC (Electronic Data Capture) systems, which meet the relevant regulatory requirements.

The combined medical and technical skills of our highly qualified staff means that we are able to develop individual software solutions that are tailored to our customers’ requirements in observational studies, like Post Marketing Surveillance (PMS), Non-Interventional Studies (NIS) or Post-Authorisation Safety Studies (PASS),. With regards to the ever increasing complexity of health reform, we can support you in the cost-benefit assessment of your product, the preparation of dossiers for the detection of the additional benefits of a new compound or medicinal product and in the calculation of the amount to be refunded as well as the pricing in the authorised indication. Our purpose-built EDC systems are customised for each customer’s individual need. In particular, with our internet-based documentation system, PMSBOX we provide a customized programme for lPost Marketing Surveillance (PMS), Non-Interventional Studies (NIS) or Post-Authorisation Safety Studies (PASS). Similarly, our OPVERDI document management system, which conforms to the relevant regulatory authority requirements, provides a variety of options for the presentation, management and security of data from phase I through to phase IV clinical trials. For authorised users, both software systems are accessible via the internet and both are suitable for observational studies. This enables flexible working arrangements for everyone in the clinical project and additionally has a budget-saving impact on travel costs.

Click here for detailed information on our software solutions in observational studies, like Post Marketing Surveillance (PMS), Non-Interventional Studies (NIS) or Post-Authorisation Safety Studies (PASS):

http://www.oandp-cro.com/software-solutions/pms-box-edc-system/

Observational studies: Years of experience at Dr. Oestreich + Partner GmbH

As a full-service CRO (Clinical Research Organisation), we provide our customers with expert consultancy in the areas of Post Marketing Surveillance (PMS), Non-Interventional Studies (NIS) or Post-Authorisation Safety Studies (PASS) and Phase II trials with additional patient groups to analyse the cost-benefit ratio and for proof of evidence of the added value according to the requirements of the law on the restructuring/reorganisation of the German medicinal product market (AMNOG).

Our extensive international network of monitors and local partners enables us to work flexibly in diverse medical indications and specialist areas. We have year-long experience in clinical projects at both the national and the international level. In order to ensure effective observational studies and post marketing surveillance (PMS), we ensure that key personnel are contacted in a timely fashion, we prepare or collate the necessary medical documents - from protocols and study summaries through to submissions to the competent authorities. As required, we also translate documents or carry out in-depth literature searches.

Click here for an overview of our services in the areas of Post Marketing Surveillance (PMS), Non-Interventional Studies (NIS) or Post-Authorisation Safety Studies (PASS):

http://www.oandp-cro.com/software-solutions/pms-box-edc-system/


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

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