Medical Biometrics

Medical Biometrics based on statistical analysis

The company, Dr. Oestreich + Partner GmbH, provides comprehensive medical biometric services for the identification and application of statistical methods in all areas of basic research and patient-oriented studies. Our highly qualified medical biometry team has year-long experience in the successful conduct of projects in clinical research and development, from first proof of concept, through long-term clinical follow-up to the economics of health care. In the area of medical biometrics we carry out statistical planning, including any interim analyses, calculation of case rates and the rationale behind these.

For parallel-group study designs, the randomisation of study participants is achieved by referring to the pre-specified randomisation plan. Furthermore, we carry out data management, data coding according to international or internal standards, and statistical interim analyses and the final medical biometric evaluation. The preparation of the final report can be completed in almost any language - it includes separate text, table and graph sections. We also develop evidence-based strategies, cost-benefit analyses, projects on patient satisfaction, quality of life and treatment efficacy.

Click here for a brief overview of our services in medical biometrics:

Medical Biometrics: professional consultancy with 30 years experience in clinical research and development

As a full-service clinical research company, we additionally provide audits and presentations, seminars and internships for physicians, companies and healthcare facilities in our training centre in Cologne to include medical biometric instruction. Our highly qualified staff carry out the comprehensive searches of the relevant literature in addition to the preparation or analysis and editing of medical texts - from summaries of trials through to documents for doctors to publications or manuscripts. All processes are carried out with reference to our internal or the customerĀ“s SOPs, which are in accordance with regulatory legislation and guidelines. Similarly, we provide our customers with a variety of document management systems to enable efficient and result-oriented project work. Our internet-based databases PMSBOX and OPVERDI conform to regulatory requirements and can be customized to create individual, multilingual electronic case report forms (eCRF), which also enable the direct integration of external data (laboratory results, results of imaging examination procedures, ECG, etc.). These software solutions are available to all authorized users to review and/or input the data online during the course of the entire project. Our customers decide if they wish to develop the eCRF themselves or if they wish to us to address the required medical biometrics issues.

Furthermore, we provide telemedicine systems for the measurement of physiological parameters (blood pressure, pulse, ECG, pulmonary function, body weight, etc.) in both the inpatient and outpatient settings. The measurements can be carried out continuously or intermittently, and either automatically by the specific medical device or measured and documented by the patients themselves enabling close monitoring of the latter. Based on the data thus collected, statements of compliance, efficacy, tolerability and the safety of diagnostic and treatment approaches and so forth can be made.

Click here for an overview of our software solutions for medical biometrics:

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