Project management

“Turning hypotheses into results.”

Project planning and coordination

We plan, coordinate, and manage projects from start to finish. We create detailed timelines, assign tasks, secure the necessary resources, and maintain clear communication to ensure all stakeholders are aligned.

We work closely with physicians, data analysts, regulatory experts, and other specialists to minimize risks and ensure full compliance with regulatory requirements and project milestones. Our goal is to keep your project running smoothly, efficiently, and on schedule — within budget, aligned with its purpose, and focused on delivering the expected outcomes.

Project management

Study preparation and planning

  • Defining the study type and objectives
  • Collaborating on study design and methodology
  • Creating the project plan and study protocol
  • Securing related services, vendors, and resources (e.g. legal services, translation agencies)
  • Managing contractual arrangements for the study
  • Defining responsibilities of all involved parties
  • Obtaining approvals from ethics committees and regulatory authorities
  • Preparing project documentation (Trial Master File – TMF) and informed consent forms (ICF)

Feasibility assessment

  • Evaluating the feasibility of the study in terms of patient availability, suitability of clinical sites, and financial costs
  • Assessing technical, organizational, methodological, economic, and legal aspects
  • Identifying potential challenges and opportunities before project launch

More information on this service is available in the dedicated section.

Study management

  • Assembling, managing, and coordinating the project team
  • Scheduling and overall project coordination
  • Financial management of the study
  • Risk, quality, and regulatory compliance management
  • Vendor management
  • Organizing trainings
  • Managing and tracking the project throughout all phases
  • Communication with sponsors, third parties, and study participants
  • Monitoring and reporting study progress, compiling summary reports for the sponsor

Site and patient recruitment management

  • Negotiation and finalization of agreements
  • Contracting with clinical sites, physicians, and laboratories
  • Coordinating patient recruitment activities

Study monitoring

  • Preparing the monitoring plan
  • Organizing training for monitors
  • Preparing and compiling the Investigator Site File (ISF)
  • Conducting site visits:
    • Site Initiation Visit (SIV)
    • Monitoring Visits (MOV)
    • Close-Out Visit (COV)

Study close-out and archiving

  • Coordinating the final analysis of the study
  • Finalizing financial and administrative matters, including closure with ethics committees and regulatory authorities
  • Archiving study documentation, data, and database closure

Drafting the final study report

  • Contributing to the Clinical Study Report (CSR) summarizing the study results