At SmartTrial a Project Manager is assigned for each project. Our project managers are responsible for organization and control of project execution, prediction of potential problems, analyzation of trends and optimization of all project stages.
- guaranty approval by regulatory authorities
- optimal budget and high feasibility
- all clinical trials (I-IV phase, bioequivalence, observational program)
- free sample size calculation
- investigational sites selection
- monitoring and pharmacovigilance
- full set of documents (investigator’s brochure, synopsis, study protocol, patient informed consent form, case report form, final study report, summary of product characteristics)
- three-stage quality control
- review by expert in relevant speciality (PhD)
- typical or individual templates
- case report form design
- sample size assessment
- statistical analysis plan development
- randomization list
- data management and statistical analysis
- medical publications of any complexity
- literature review
- competitive product advantages assaying
- authors selection or ghostwriting
- scientific content for your opinion leaders (presentation, media kit)
- lectures and conferences
- medical translation services
Documents are written by specialists with a scientific, medical background and statistical expertise. All medical writers hold a PhD in Medicine. Documents are compliant with the corresponding ICH GCP principles and current regulations of the authorities.
Our company closely cooperates and attracts as scientific consultants candidates and doctorates of medical science from academic teaching staff of the largest medical university in St. Petersburg and Moscow.
At SmartTrial biostatistics have many years of experience in clinical trial data analysis, including such services as sample size determination, generation and/or formatting of randomization tables, statistical analysis plan development, statistical analysis with generation of a statistical report.