Study feasibility

Smooth Drug Development offers an assessment of clinical trial feasibility and site selection in Russia, CIS and Baltic States.
The process of clinical trial documents development always include the assessment of the possibility of future research including obtaining of approvals, recruitment and patient retention and technical and logistical constraints.
These factors influence on the choice of research nosology, geographical coverage, pool of sites, patient population, approaches to the study design, and consequently – the time and cost of a study for the Sponsor.
Data collected during clinical trial feasibility assessment are the basis of the budget and schedule of the study. Accuracy of the forecasts made at this stage determine timings of further development and registration of the product. Overoptimistic approach may lead to extended terms of the trial and delay the product launch.
Study feasibility include:
Scientific, medical and ethical aspects (program / study level)
  • Scientific value
  • Relevance of the candidate molecule for practical medicine
  • The prevalence of the disease
  • Availability of standard treatments
  • Availability of alternative treatment options
  • Risk-benefit ratio for patients
Regulatory aspects (country level)
  • Requirements of regulatory bodies of the planned countries
  • Needs of country-specific protocol versions 
  • Possibility and timelines of approvals for:
    • Clinical trial conduct
    • Import of the study drug
    • Export of biological samples
Logistical aspects (study / country level)
  • The need to use warehouses and their availability
  • Limitations associated with temperature control, shipment schedule and storage of the investigational product and biological samples
  • Requirements for:
    • Import of the study drug
    • Export of biological samples
    • Return / destruction of unused investigational product
Operational and clinical aspects (site level)
  • Ability to conduct research considering treatment standards
  • Having access to a pool of patients
  • Equipment avalability at study sites
  • Competence of Principal investigators
  • Availability of site staff 
  • Recruitment potential
  • Requirements of Ethics committees
  • Influence of competitive trials
  • Special conditions for conduct of the study
Financial aspects (center level)
  • Payment grant on similar studies
  • Adequacy of the proposed payments
  • Costs of diagnostic procedures
  • Costs for referral fees and retention of patients
Technical aspects (center level)
  • Limitations due to technical tools for:
    • Randomization
    • Collection of clinical data
    • Central imaging review 
    • Electronic tools for data collection by site
    • Electronic tools for patient reported data
As result of the feasibility assessment and preliminary site selection, our specialists prepare a detailed report, which contains the results of the evaluation and a list of potential study sites.