We are a service provider for the pharmaceutical and medical device industry and other research organizations.
Our services in detail:
Study Planning and Design
Protocol development for clinical trials and all types of non-interventional studies. Biometric consulting regarding study design, including sample size estimation and randomization. Also for electronic trials (eTrials).
Case Report Forms and Documents (paper-based or electronic)
Concepts and layouts for Case Report Forms (CRF) and any other type of documents for clinical trials. Editorial service, printing and logistics. Concept, rogramming and validation of eCRFs.
Study placement, investigator recruitment, CRF-tracking, reporting of adverse events, monitoring , granting of investigators, monthly reporting to the sponsor.
Development of data collection guidelines, database specifications and logic checks design.
Performance of CRF-tracking and data clarification tracking, double data entry, coding, automated data clarification forms generation, database editing and quality control reviews.
Taking over electronic data (e.g. from eTrials).
Descriptive analysis of data by generation of tables, graphs and listings. Testing of hypotheses by state-of-the-art methodology. Use of validated software packages (primarily IBM SPSS®, and others).
Statistical estimation of sample size and power calculations.
Methodological & statistical support for reimbursement dossiers
Support on all aspects of statistical analysis required for HTA submissions. E.g.:
• Meeting requirements for a reimbursement dossier submitted
to IQWiG (Germany)
• Demonstrating clinical effectiveness and added value over the standard care
• Performing indirect treatment comparisons, meta-analysis or
Periodic Safety Update Reports (PSUR).
Literature screening for adverse drug reactions.
• Clinical study reports according to ICH Guideline E3
• Clinical investigation reports for medical devices according to EN ISO 14155
• Clinical evaluation reports for medical devices according to MEDDEV 2.7.1
• Manuscripts for publication including literature research including submission process
• Summary of product characteristics (SPC), package insert, brochures, informed consent forms.
As an independent external quality assurance unit, we perform many types of audits:
• On-site audits for clinical sites
• Document audits for investigation plans, protocols, CRFs, Informed consent, etc.