Project and site management

  1. Submission of study documents to the responsible ethics committee(s) and competent authority(ies).
  2. Coordination of different parties involved (packaging / shipping of study medication, central laboratories, etc.)
  3. Managing the study sites, and organize remuneration
  4. Organization of regular project meetings / TCs
  5. Generation of regular status reports
  6. Compilation of the trial master file

Data Management 

  1. Generation of the data management manual
  2. Generation of the validation plan
  3. Set-up of paper CRF or electronic (e)CRF applications
  4. Data base development and validation
  5. Programming of checks
  6. Data entry and verification (double data entry)
  7. Data cleaning and query management
  8. Coding of medical terms with MedDRA and WHO-DD
  9. CDISC competence
  10. CDISC / FDA conform data export

Monitoring

  1. On-site monitoring
  2. Telephone monitoring
  3. Remote monitoring
  4. Risk-based monitoring

Medical Writing

  1. Investigator’s brochure
  2. Clinical study protocol
  3. Informed consent form for adults or children
  4. Clinical study report according to ICH E3
  5. SAE narratives
  6. CTD support

Statistical Consultancy

  1. Development of the study outline
  2. Adequate choice of the trial design including e. g. options of group sequential or adaptive designs
  3. Formulation of hypotheses suitable for addressing the study objectives (e. g. superiority, non-inferiority, equivalence)
  4. Adequate choice of significance level(s) and power, adjustment in case of interim analyses or multiplicity
  5. Provision of reliable sample size estimates

Statistical planning of clinical studies

  1. Writing the statistical section of the study protocol
  2. Generation of the statistical analysis plan

Statistical analysis & reporting of clinical studies

  1. Programming of analysis files (e. g. CDISC ADaM)
  2. Programming statistical tables and graphs using SAS®
  3. Performance / programming of statistical analyses
  4. Program validation
  5. Generation of a statistical study report or statistical contribution to clinical study report

Pharmacokinetics / Pharmacodynamics

  1. Development / review of PK/PD analysis plans
  2. Calculation of PK parameters (non-compartmental)
  3. PK modelling / simulation
  4. Pop PK and PK/PD modeling
  5. Software: Phoenix® WinNonLin®, NLME®

Quality assurance

  1. Contracted external audits
  2. Sponsor SOP development
  3. QA consultancy
  4. Contracted QA for sponsor study