Study Design
Simulation of different designs (including group sequential and adaptive designs);
sample size calculations;
Randomization and blinding scheme selection
Medical Writing
Development of Clinical Study Protocol;
Development of Essential Documentation;
Final Study Report
Obtaining Regulatory Approval
Regulatory strategy and planning and document preparation for study submission
Site selection and study feasibility
Confidentiality Agreement (CDA) development, feasibility questionnaire (FQ) development, site selection with own pre-qualified database and feasibility report writing
Study start-up activities
Clinical Trial agreement execution with selected sites, training of study participants, compilation of study files and patient binders an conducting site initiation visits (SIV)
Clinical Monitoring and Project Management
Developing plans and timelines for research projects, routine monitoring visits (RMV) of investigational sites, site recruitment support, site payment management, remote monitoring, partial and full source data verification (Risk-Based Monitoring)
Quality Assurance
Study audit plan preparation, performing independent audits of investigational sites and pre-inspection preparation visit conduction
Data Management
Paper CRF and eCRF design and planning, development of CRF completion guidelines, development of data management plan, paper based or electronic data capture, data edit check planning and management and query Management
Biostatistics
Database development, validation, and maintenance, writing the statistical analysis plan (SAP), creating statistical tables, data listing and figures for clinical study reports and statistical Analyses and Interpretation
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