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).
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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.
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