Data management plan

To enable reliable subsequent decisions regarding product development after successful completion of clinical testing, both meticulously designed and implemented studies as well as the statistical analysis of data by highly qualified experts are required. With more than two decades of experience, Dr. Oestreich + Partner is your expert partner when it comes to preparing a sound data management plan for clinical trials. We support our clients throughout the entire process, from the initial planning phase to successful marketing of a product. As the coordinating intermediary, we prepare a logical and coherent data management plan that incorporates the requirements of all authorities, commissions, sponsors, investigators, patients and other parties involved in a clinical trial. Our full range of services includes the comprehensive retrieval and bundling of all relevant data for the generation of a cost-benefit analysis and for the positive proof of the added benefit of new drugs compared to the therapeutic standard treatment in accordance with the AMNOG (German Law on the Reorganization of the Pharmaceutical Market - Arzneimittelmarktneuordnungsgesetz).

Click here to find out more about data management planning at Dr. Oestreich + Partner:

Data management plan

The path to success with a sound data management plan

Our data management plan reflects our clients’ interests to the highest degree and sensitively addresses budgeting and cost management issues for all phases of the clinical trial. Based on our data management plan, we establish contact with all key parties at an early stage and establish a goal-oriented plan for everyone involved in the project, taking into account the time frame and costs.

Our various editing and documentation systems enable the structured selection of patients for clinical trials in the prophylaxis, therapy, prevention, treatment, medical care and economics of all medical indications. Moreover, all authorized staff members involved in clinical trials will be instructed both with regard to the course of the overall project as well as individual job-related responsibilities to provide an economical, goal-oriented division of labor.

Click here for an overview of our data management planning services:

Data management plan

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