Services

Service profile

We are a service provider for the pharmaceutical and medical device industry and other research organizations.

 

 

 

 

Our 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
  • Clinical Evaluation Reports according to MedDEV 2.7.1 (Rev. 4) for medical devices
    based on the actual Medical Device Regulation
  • 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
     

Data Management and Statistics

Competent clinical data management in a timely manner. Conventional (paper-based) or electronically (via an EDC-System). Services start in the planning phase with the creation of clinical trial protocols or observational study plans and case report forms. Later in entering the data (paper-based) or transferring the data (from EDC) into the analysis database. Including data cleaning. Finally your data are analysed statistically in order to respond your research questions properly. Results can be presented as Clinical Study Reports or Clinical Investigation Reports, posters or publication manuscripts.

Medical Writing

Publication manuscripts for scientific journals, also as Ghost-Writer, including the complete submission and review process.

Health Technology Assessment (HTA) Support:
• 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

Monitoring & Audits

As a clinical monitor I will assure that your study is being conducted according to your standard operating procedures (SOPs), good clinical practice (GCP) and the acutal legal requirements.

I can assist you in the initiation of clinical studies as well in the conduct of clinical studies. I will check the data „on site“ or „remote“ for completeness and plausiblity and verify them against medical patient records (source data verification).

Based my data managment background, I am able to detect errors rather early or are able to help to prevent these errors. The „direct link“ to the data management is speeding up the data cleaning process substantially.

Additionally, I can offer "on-site audits" for your clinical sites as well as database audits or document audits.