Our high qualified professionals organize phase I-IV. clinical trials where quality and reliability aspects are in focus.

We provide the following services in clinical trials:
  • Planning and preparation of clinical research
  • Monitoring
  • Medical monitoring
  • Data management
  • Medical writing
  • Quality assurance
  • Clinical Research Associate Training
Planning and preparation of clinical research
  • Designing and conducting feasibility studies
  • Site selection
  • Composing Patient Information Sheets and Informed Consent Forms
  • Assembling, Submitting and Tracking regulatory approval application packages
  • Committees of Ethics
  • Contract management
  • Compiling Investigational Site Dossiers
  • Organizing and conducting Investigators’ meeting

We have clinical trial management experience in all therapeutic areas. It is our internal goal to start the clinical trial within 1 week after the regulatory approval is obtained. Our colleagues accomplish their tasks with continuous quality assurance and management support, which results in adequate level of ”real-time” inspection readiness. We have liability insurance for our clinical trial monitoring service.

Medical monitoring

We offer medical monitoring in various therapeutic areas, even at a regional level. Our colleagues with international experience in clinical trials provide high-level scientific and background support for the monitoring team.

Data management
We process full data management services and the following IT services:
  • development of data-specification requirements for electronic data processing systems
  • electronic data capturing systems building with computer technology tools suitable for pharmaceutical industry
  • data handling document, application and other data interface using SQL, SAS,Web, C++ or Visual Basic programming language development
We provide data administration tasks:
  • checking data quality within the clinical database
  • continuous tracking of clinical trial data status and preparation of summary reports
  • organizing all kinds of data handling processes
Medical writing

We are ready to help our clients in writing the following documents:

  • Non-interventional and clinical trial protocols
  • Preparation of reports for phase II-IV clinical trials and non-interventional trials according to international guidelines.
  • Investigator’s Brochure
  • Annual Safety Report/Development Safety Update Report
Quality assurance

Our company maintains an internal quality assurance system; our processes are documented in seamless standard operating procedures.

Our services:

  • Developing, maintaining and amending standard operating procedures and process descriptions
  • Designing and editing forms
  • Preparation for Regulatory Authority inspections
Clinical Research Associate Training (CRA, SC)

We provide the following trainings for Clinical Research Associates:

  • academic training consisting of 10 modules
  • practical training (accomplishing given number of co-monitoring visits)
  • Advanced training for monitors focusing on quality assurance
  • Study coordinator training
  • Professional pharmaceutical business English training


Go to Regulatory Affairs