With one of the largest biostatistical departments in Europe, Pierrel Research offers full service for design and methodology within clinical trials.
Different expertise and backgrounds form a creative mixture and the basis for constructive and client-oriented statistical work.
Beyond the standard biostatistical work, we offer highly sophisticated methodologies such as adaptive designs, psychometrics including scale development, population pharmacokinetics, meta-analysis, overall safety analyses and others.
- Parallel Group Design
- Cross-over Design
- Factorial Design
- Multicentre Trials
- Superiority Trials
- Non Inferiority/Equivalence Trials
- Dose-Response Designs
- Group Sequential Designs
- Sample size determination or power considerations on trial design using adequate software programs
- Generation of randomization lists for simple and special designs, e.g., stratification, random block sizes
- Choice of scales for clinical trials
- Support of safety reviews during a trial, e.g., support for Data Safety Monitoring Boards (DSMB) ensuring limited or blinded access to results and generation of tables, listings and figures
- Planning and performance of statistical interim analyses, interpretation of results and advice for further conduct of the clinical trial
- Preparation of comprehensive Statistical Analysis Plans (SAP) according to international rules and regulations
- Preparation and conduct of Blinded Data Review Meetings and summaries of results, provision of final allocation to analysis populations based on automatic assignment
- Performance of statistical analyses and generation of tables, listings and figures in a clear and standardized structure
- High level SAS programming, SAS macro library covering special methods
- Reporting and presentation of results, interpretation from the statistical perspective and supporting conclusions
- Meta-analyses, overall evaluations for efficacy or safety endpoints, use of fixed and random models, adequate graphical presentation
- Safety dossiers, overall safety summaries taking into account different trial settings and coding
- Pierrel Research has got more than 20 years of experience in the development, validation and analysis of:
- innovative health-related quality of life questionnaires
- unique disease-specific instrument to measure treatment effects or changes in disease status
- typical psychometric scales, disease-specific scales, questionnaires (e.g. symptom-related, HrQoL scales, QoL scales) and mixtures of these concepts as specified in the PRO guideline
Pierrel Research has been actively involved in many research projects in the indication of Alzheimer disease with international leading pharmaceutical companies and conducted essential registration studies.
Our history started when Pierrel Research contributed to the development of the first Alzheimer medication Tacrine®, supported its introduction into the market and designed the so called "Cognex management set". Shortly after this first challenge, Pierrel Research, always concerned with the health, was deeply involved in the clinical trials and introduction into the market of Exelon® and, later on, of the innovative drug Memantine®, which was the first drug indicated for severe Alzheimer.
Nowadays and besides its participation in clinical trials, Pierrel Research has developed and validated a new scale to measure the efficacy of Alzheimer medication, ROSA® (Relevant Outcome Scale for Alzheimer’s disease).
- Construction and development of tests and scales based on the classical test theory
- Starting with collection of "if" items and planning of appropriate trial
- Items reduction, optimizing of the scale
- Determination of scale characteristics
- Validation of tests and scales
- Analysis of patient reported outcome according to PRO guideline
- Econometric analyses, cost analyses for different purposes based on different models
- PK/PD analyses including complex modeling (compartmental and non-compartmental), use of powerful software