Clinical Trials

Clinical Trials

For over two decades, Dr. Oestreich + Partner GmbH has been a competent partner for the conduct of clinical trials in the areas of prevention, treatment, care and economics, and for all medical indications. We accompany our clients from the initial planning through to the successful conclusion and see ourselves as a coordinating intermediary between competent authorities, ethics committees, sponsors, physicians, patients as well as all other parties involved in the clinical trial. We also offer the full spectrum of services for projects in the areas of cost-benefit analysis and confirmation of the benefits of new drugs compared to standard therapy according medicinal product prescribing legislation, such as AMNOG (Arzneimittelneuordnungsgesetz) in Germany.

In the project planning stage we have the interests of our sponsors uppermost as demonstrated by tight control of budgeting and cost management for clinical trials. We ensure that all key parties are contacted sufficiently early in the process and prepare a cost-, time-, and goal-oriented project plan for all participants.

To enable the optimal start of a study, we select patients for clinical trials in the prevention, treatment, care and economics of all medical indications in a structured manner drawing on our content management and documentation systems. Furthermore, prior to study start, we also instruct all staff involved in clinical trials, on the conduct of the entire project, in addition to the individual job-related responsibilities to ensure efficient division of labour.

Clinical Trials with Rapid Decision-Making Processes Enabled by Fast Technology

For clinical trials in the prevention, treatment, care and economics of all medical indications, we provide our internet databases OPVERDI and PMSBOX. These enable the production of high-speed electronic CRFs in multiple languages. In addition, the results of separate investigations (for example, laboratory tests, ECG, imaging techniques, such as ultrasound, telemedical results from patient self-monitoring), which are crucial to the decision-making process can be integrated into the databases. Real-time access of the data also enables all authorised personnel to obtain an up-to-date overview, without them having to be present at the study site.

Similarly, we organise events and seminars, taking into particular consideration the increasing number of regulations and guidelines for clinical trials.

Detailed information on clinical trials and clinical research for investigators can be found here:

http://www.oandp-cro.com/software-solutions/opverdi-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