Study set-up

You’ll receive focused, one-on-one interaction and streamlined, responsive communication with experts who can help:

  • Clinical development and strategy
    • Develop clinical research plans 
    • Maximize performance and efficiencies in clinical development
    • Manage clinical programs and data analytics
  • Protocol and medical writing 
    • Clinical study protocols for medicinal studies
    • Clinical study protocols for food and nutrition studies
    • Clinical investigation plans for medical devices and in-vitro devices  
    • Protocol review from regulatory and GCP perspective
  • Study planning 
    • Study design 
    • Study feasibility
    • Schedule planning
    • Consultation

Engagement of the professional sites and investigators is a crucial element in clinical trials. With our large network of trial infrastructure in the Nordic and Baltic areas we can ensure qualified performance of the sites.

  • Site evaluation 
    • Site feasibility
    • Principal investigator (PI) identification
    • Site qualification visits
  • Translations and local adaptation of study documents
  • Data management plans (eCRF planning, set-up and review)

With Medfiles, you have a true partner that is invested in your results and dedicated to your success.

Study initiation

  • Study registrations
    • CTIS / EudraCT
    • EFSA
    • ClinicaTrial.gov
    • Etc
  • IEC and regulatory submission         
    • CTIS submission via EU portal
      • Part I and Part II documents
      • Portal follow-up
    • Ethics Committee submissions for non-pharma studies
    • Regulatory submission for non-pharma studies
    • Data permit and biobank applications
    • Translations and localisation of documents
      • Informed consents form
      • Layman’s summaries
      • Study synopsis
      • Patient diaries and other materials
  • Study documentation
    • Project plan
    • Risk management plan
    • Trial master file (eTMF) set-up,
    • Monitoring Plan
    • Investigator Site File preparation
  • Vendor management
  • Site contract and negotiations 
  • Site initiation visits
  • Site staff training and support

STUDY CONDUCT

Medfiles matches the right team to your investigational new drug, food or device clinical program to ensure the highest quality data review and interaction between study sites. We have a strong Nordic presence (Finland, Sweden, Estonia, Latvia, Lithuania) and in addition a global network of regionally based clinical research associates. Our clinical project managers are experienced and highly trained, with and specialized knowledge in clinical trial monitoring procedures, regulatory guidelines covering a wide range of therapeutic areas.

  • Monitoring plans set-up and updates 
  • Ensurance of GCP compliance 
  • Monitoring 
    • On-site or remote monitoring 
    • Centralized monitoring
      • Uniform practices
      • Remote evaluation of accumulated data 
  • Risk-based Monitoring
    • Risk evaluation based monitoring 
    • Dynamic process 
    • Signal detection 
    • Scientific consideration 
  • Study documentation 
    • Collection of essential documents
    • TMF maintenance
      • Agatha eTMF 
    • ISF maintenance 
  • Pharmacovigilance and Risk Management
  • Data management
    • Data handling (electronic CRFs)
    • Query handling

End of study activities

The most exciting phase of the study is once data verification begins and the data base is closed as the  project is approaching the reporting phase. It is important that both the conduct of the study and the obtained results are documented as required from both a scientific and regulatory point of view. 

  • Site close-out visits
  • End of study notifications 
  • TMF delivery, archiving
  • Statistical analysis
  • Interim reports
  • Final report 
    • Clinical study reports 
  • Scientific publications
  • Archiving

Project management

Medfiles carefully assigns project managers with proven expertise in clinical research to each project. The clinical project manager (CPM) assigned to each study will provides ongoing consultation and coordination, while communicating all aspects of the study as defined by you. 

Our dedicated project managers perform a variety of functions including:

  • Ensurance of progress of the study 
  • Serving as a primary resource and point of communication for the client and project team
  • Effectively utilizing our global partners and technical resources including eCRF, eTMF, EMR providers  
  • Optimizing your site selection and feasibility analysis
  • Providing leadership and direction to the project team, including identifying and tracking specifications for time, quality, and cost of deliverables
  • Identifying, documenting, and mitigating risks early in the process to address any potential obstacles
  • Applying a proactive approach to develop a project team focused on quality and efficiency
  • Communication of issues and solutions
  • Projects “what if” scenarios
  • Having “big picture” of the protocol and Sponsor’s objectives 

With custom solutions for early- and late-phase clinical trials and a team of highly experienced project managers, Medfiles ensures that your projects are completed on schedule and within budget while complying with international quality standards.

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