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
Monitoring
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