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+7 (931) 005-53-11

Pharmaceutical outsourcing
Clinical trials
Medical advisors

Services

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Study design and planning:
  • 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
Documentation development and auditing:
  • 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
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Data management and biostatistics:
  • case report form design
  • sample size assessment
  • statistical analysis plan development
  • randomization list
  • data management and statistical analysis
Medical advisor:
  • 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
  • infographics
  • medical translation services
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Experts

1
Project managers

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.

2
Medical writers

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.

3
Scientific advisers

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.

4
Biostatisticians

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.