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Project and site management
- Submission of study documents to the responsible ethics committee(s) and competent authority(ies).
- Coordination of different parties involved (packaging / shipping of study medication, central laboratories, etc.)
- Managing the study sites, and organize remuneration
- Organization of regular project meetings / TCs
- Generation of regular status reports
- Compilation of the trial master file
Data Management
- Generation of the data management manual
- Generation of the validation plan
- Set-up of paper CRF or electronic (e)CRF applications
- Data base development and validation
- Programming of checks
- Data entry and verification (double data entry)
- Data cleaning and query management
- Coding of medical terms with MedDRA and WHO-DD
- CDISC competence
- CDISC / FDA conform data export
Monitoring
- On-site monitoring
- Telephone monitoring
- Remote monitoring
- Risk-based monitoring
Medical Writing
- Investigator’s brochure
- Clinical study protocol
- Informed consent form for adults or children
- Clinical study report according to ICH E3
- SAE narratives
- CTD support
Statistical Consultancy
- Development of the study outline
- Adequate choice of the trial design including e. g. options of group sequential or adaptive designs
- Formulation of hypotheses suitable for addressing the study objectives (e. g. superiority, non-inferiority, equivalence)
- Adequate choice of significance level(s) and power, adjustment in case of interim analyses or multiplicity
- Provision of reliable sample size estimates
Statistical planning of clinical studies
- Writing the statistical section of the study protocol
- Generation of the statistical analysis plan
Statistical analysis & reporting of clinical studies
- Programming of analysis files (e. g. CDISC ADaM)
- Programming statistical tables and graphs using SAS®
- Performance / programming of statistical analyses
- Program validation
- Generation of a statistical study report or statistical contribution to clinical study report
Pharmacokinetics / Pharmacodynamics
- Development / review of PK/PD analysis plans
- Calculation of PK parameters (non-compartmental)
- PK modelling / simulation
- Pop PK and PK/PD modeling
- Software: Phoenix® WinNonLin®, NLME®
Quality assurance
- Contracted external audits
- Sponsor SOP development
- QA consultancy
- Contracted QA for sponsor study