We are Prague Clinical Services. A full-service, independent contract research organisation.(CRO)

Established in the historical and culturally-renowned city of Prague in the Czech Republic, our customers include a range of clients from Europe, the USA and Asia. Thanks to many years of professional work, extensive experience and consistently high quality in the field of clinical studies, Prague Clinical Services has become one of the leading independent clinical research service providers in the Czech Republic and in Central and Eastern Europe.

About

About

Our experienced team provides a complete solution for clinical research projects in all phases of the development of drugs and medical devices.

The senior management has more than two decades of experience in clinical development, the planning of clinical studies and their execution.

We’re not just a service provider for organising and performing clinical studies, but also a partner in the development of new drugs and medical devices.

The scope of PCS activities includes complete project development management. PCS can also organise regulatory scientific advice meetings in Europe and in the USA for study Sponsors.

In addition, PCS is very active in the field of teaching programmes relating to pharmaceutical medicine and also cooperates closely with legal authorities in the development of clinical study legislation. Petr Janda, the CEO of PCS is the president of ACRO-CZ - the Czech CRO association, which is a member of EUCROF, the European CRO Federation.

Process

  • Study design proposal
  • Document writing & Regulatory submission
  • Complete organisation of the study
  • Providing the clinical study report

Services

Clinical development services for Phase I-IV clinical studies and clinical investigation of medical devices.

  • Clinical Operations

    • Feasibility studies/ site selection
    • Site contracting & investigator grant payment
    • Study monitoring
    • Site management
    • Project management (regionally or globally)
    • Drug supply logistics and storage management
    • Study supply logistics and storage management
    • Direct line management of staff (in sourcing)
    • Vendor Management
    show all operations
  • Regulatory services

    • Regulatory and ethics committee submissions
    • Scientific advices – Europe, USA
    • Support in marketing authorisation process
  • Medical writing

    • including design, study protocol and study reports
  • Data management

  • Biostatistics

  • Quality assurance

  • Pharmacovigilance

  • Bridging studies

  • Medical monitoring

Quality training

Quality and compliance with European GCP standards are our priority. PCS has developed a sophisticated system of SOPs which is constantly updated and maintained in accordance with the changing legislative environment. PCS has an internal QA department and cooperates closely with external experts to assure the highest possible quality of outcome.

Continuous training is a mandatory part of the QA system and is maintained on a regular basis for all PCS employees and external co-workers.

Company & Contacts

Chief Executive Officer

Petr Janda
Petr Janda

Petr Janda is the Founder and Chief Executive Officer (CEO) of Prague Clinical Services. Petr is responsible for business management and development of new opportunities. With strong background in the field of medicine as medical doctor coupled with more than 20 years of professional experience in pharmaceutical industry and CRO management, Petr overlooks the PCS activities and actively develops new business opportunities. Petr serves as the President of the Czech CRO Association – ACRO-CZ.

Headquarters

The headquarters of PCS are traditionally located in Prague, Czech Republic. PCS has employees in most European countries, the USA, Japan and China. PCS staff consist of its own employees, contracted CRAs and partner organisations. With these people PCS is able to cover almost all of the European countries and partly the USA, Japan and China.

Contact us