Monitoring Clinical Trials

Monitoring Clinical Trials by Dr. Oestreich  Partner

We provide both on-site and online monitoring for the monitoring of clinical trials. The monitoring of clinical trials is conducted efficiently and reliably with the support of up-to-date software solutions. Our highly experienced multi-disciplinary staff is there to assist you in all the required specialist fields. We additionally draw on a large network of local monitors and partners with year-long ICH-GCP experience, which means that the monitoring of clinical trials can be carried out in all medical indications with increased cost efficiency.

At Dr. Oestreich + Partner GmbH medical and technical expertise can be combined to ensure the highest level of quality in the monitoring of clinical trials. For over 10 years our proprietary web-based online systems, OPVERDI and PMS Box, have been operational global in the most current respective versions and in multiple languages. OPVERDI and PMS box are EDC (Electronic Data Capture) systems, which have been developed specifically for the conduct of international clinical research projects. Over and above the electronic monitoring of clinical studies they also allow the completion of many other activities, without having to visit the investigational site.

Monitoring Clinical Trials – the Advantages

Through the use of internet-based EDC systems, all involved parties can be informed of the status of the monitoring of clinical trials in real time. Project managers, investigators, other authorised users and monitors are all linked with each other. They can exchange information and make joint decisions with regard to the latest results from the monitoring of clinical studies. In addition, the regularly updated project folder enables the monitors to prepare their visits to investigators.

The use of modern EDC software technology enables not only the prevention or the easy correction of errors, but by electronic means communication is faster and can be carried out in various languages. In this way, substantial time savings can be achieved. In addition, all parties involved in the monitoring of clinical studies have access to a central and consistent data pool that can be rapidly accessed and analysed. Using electronic means, such as study plan amendments and interim analyses can be more flexibly adapted during the study.

Read more about our EDC software solutions and the monitoring of clinical trials - Click here!

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