I am a service provider for the pharmaceutical and medical device industry and other research organizations.
Services in detail:
- Planning of clinical trials
- Statistical sample size and power calculation
- Data management of clinical trials
• Classic (paper-based)
• Electronic (database design, EDC, data validation, data documentation)
• Data management plans, data validation plans - Monitoring of clinical trials (classic or electronic)
• Study initiation, routine visits, close out visits
• Centralised and/or risk based monitoring - Auditing (worldwide)
• On Site (clinical sites)
• Database audits, Document audits - Statistical analysis of clinical studies and other research projects
• Clinical studies with drugs and/or medical devices
• Non-interventional studies (NIS), Investigator Initiated Trials (IITs) - Health Technology Assessment (HTA)
• Support for HTA submissions (e.g. reimbursement dossiers acc. to AMNOG)
• Systematic literature search
• Identification of patient relevant endpoints in available data
• Appraisal of study results
• Definition and analysis of appropriate subgroups
• Calculating direct or adjusted indirect comparisons and performing meta-analysis
• Co-operation in setting up the dossiers for the HTA agencies - Medical Writing
• Publication manuscripts (with or without literature search)
• Posters for congresses or symposia
• Powerpoint presentations - Support for Post-Marketing-Surveillance and Clinical Evaluation of medical devices
based on the Medical Device Regulation 2017/745 - Independent Data Monitoring Committee (DMC) for clinical trials
• As Statistician, on request together with a Clinician and a Pharmacist
• Review of unblinded study data
• Recommendations for the safety of the study subjects
• Assurance of validity and scientific quality of the study
• Recommendations on efficacy endpoints, if required
• Recommendations on the benefit-risk-ratio