We also provide outsourcing services and flexible solutions for investigator-initiated studies.

Medfiles has a complete range of SOPs (standard operation procedures) for both clinical studies and medical device investigations. In addition, regulatory requirements for clinical studies and later submissions both for pharma and food area are taken into account in our clinical services. We can also help you with register studies, health economics in clinical trials, consultation and training.

Clinical study

  • Study planning
    • Study feasibility
    • Schedule planning
    • Consultation
    • Clinical research plans
  • Medical writing
    • IB/IMPD
  • Site evaluation
    • Site feasibility questionnaires
    • Principal investigator (PI) identification
  • Clinical trial applications
    • Ethics committee submissions
    • Regulatory submissions / CTA
    • Translations
  • Data management
    • Data handling (paper/electronic CRFs)
    • Medical coding (MedDRA)
    • Centralized monitoring
  • Statistics
    • Sample size calculation
    • Tables and data listings
  • Protocol writing
    • Clinical studies with medicinal products (human and animal)
    • Clinical studies with food and food ingredients
    • Medical device investigations
    • Performance evaluation of IVDs
    • Protocol review from regulatory perspective
  • Project coordination
    • Project management
    • Status reporting
    • Site staff training
    • Clinical monitoring
    • TMF maintenance
    • Meeting arrangements
  • Report writing
    • Clinical studies
    • Medical device investigations
    • Performance evaluation
    • Publications

 

medfiles clinical study services

Investigational medicinal product (IMP)

Bioavailability and Bioequivalence studies

  • Selection of an appropriate study design
  • Writing of study protocols and informed consent forms
  • Independent ethics committee and CA approvals
  • Data management and statistics
  • Pharmacokinetic and statistical data evaluation
  • Reporting of study results
  • Archiving of all study-related data
  • Quality assurance

These services are offered in collaboration with our Finnish and Estonian partners:

  • Phase I units
  • Bioanalytical service providers

Food and nutrition studies

We offer studies for substantiation of health claims on foods, safety of novel foods, and efficacy of foods for special groups:

  • Selection of an appropriate study design / outcome markers
  • Writing of study protocols
  • Informed consent forms, diaries and records (incl. diet monitoring) and CRFs
  • Site selection and agreements
  • Independent ethics committee and CA approvals
  • Data management and statistics
  • Reporting of study results
  • Archiving of all study-related data

Experience

Phases

Therepeutic areas