Non-commercial clinical trials

Non-commercial clinical trials
They are subject to the same requirements as commercial research, where CRO (Contract Research Organization) is responsible for project preparation and project management, specializing in conducting research and related documentation.

Clinical Consulting
Supports non-commercial research, providing quality and completeness of documentation, and provides substantive support to researchers and universities.

Support in administrative processes

Support in preparing study documentation

Trainings

Non-clinical clinical trials
Non-commercial clinical trials are subject to the same requirements as commercial research, but in Poland, in 2015, there was a change when President Andrzej Duda signed an amendment to the Pharmaceutical Law, which aims to promote non-commercial clinical trials in research centers by:

  1. Funding health care benefits
    Art. 31d of the Act of 27 August 2004 on Public-funded Health Care Services

  2. Financing
    - medicinal products
    - foods for special nutritional purposes
    - medical devices covered by the lists referred to in art. 37 sec. 1 Act of 12 May 2011

Number of non-commercial studies in Poland
Non-commercial clinical trials are just a fraction of all

research conducted in Poland.
In Western European countries these studies constitute
approximately 40% of the total clinical trial market.

Read more about non-commercial trials in the article.
 

CRO in non-commercial research
Clinical Consulting helps in the organization and conduct of non-clinical clinical (academic) research. in:

  • The role of the CRO is to conduct research in terms of:

    • Data quality assurance,

    • Verifying the correctness of the data against the source documentation,

    • Monitoring the study,

    • Help investigatos and research teams.

  • Support for clinical trial documentation including:

    • Study protocol

    • Investigator's Brochures

    • The Informed Consent Form (ICF) and Information form for the patient

  • Administrative support:

    • Complete the necessary documents

    • Application submission to EC and CA

  • Keeping correspondence with EC (KB) and CA (URPL)

  • Trainings

    • Good Clinical Practice (GCP)

    • Training with procedures specific to the clinical trial protocol

    • Principles of keeping source documentation

    • Data entry to the database (CRF)

  • Monitoring the (audits)

  • Data entry to the database (CRF)
    As external Site Coordinators

 (...) a medical institution, ... a researcher, a patient organization, a researcher organization or another natural person.... A clinical trial is a non-commercial clinical trial. "


Pharmaceutical law, Art. 37a.

If the owner of the data obtained during a clinical trial is a sponsor, (...) or other scientific institution,