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  • Clinical Operations

    The main activity of Ltd Quintiles Latvia is a clinical research and monitoring in the assignment of pharmaceutical companies. 

    It comprises the start up documentation submission to the competent authorities (State Agency of Medicines and Ethics Committee), site selection and assessment, study start up and monitoring according to the Study Protocol, data acquisition, summarization and forwarding to the Sponsor.

    All the studies conducted in Latvia are a part of international studies. The research is done in the assignment of pharmaceutical companies (e.g., a pharmaceutical company decides to carry out a research of a new or an existing product, and Ltd Quintiles Latvia performs the role of intermediary, coordinating the cooperation of pharmaceutical company with the medical enterprise by monitoring the study process).

    There is a continuous cooperation and communication with the State Agency of Medicine, Ethics Committee. (All the documentation is prepared according the legislation and submitted in the above mentioned organizations). Employees of Ltd Quintiles Latvia perform regular visits to the Study sites (medical enterprises in Latvia).

    Ltd Quintiles Latvia follows all the Quintiles Eastern Holdings GesmbH guidelines and policies. Study agreements are signed between Study sites or Investigators and Quintiles Eastern Holdings GesmbH. Ltd Quintiles Latvia employees are just monitoring the data management at the sites.

    Clinical research in Latvia is stipulated by the Cabinet Regulation No 172 “Regulations on Conducting Clinical Trials and Non-interventional studies and Labelling of Investigational Medicinal Products, and Procedure for Conducting Inspections on Compliance with the Requirements of Good Clinical Practice” of 28 February 2006 (see:http://www.zva.gov.lv/doc_upl/MK-172-28022006-ENGv3.pdf) 
    (Amendment to Regulation No 17 as of 15.01.2008.)

    1. Clinical trials related European directives (also in Latvian), guidelines, application forms, „Q&A document” and other relevant information can be found on:http://www.eudract.eudra.org > Access to EudraCT Supporting Documentation > EudraLex Volume 10

    2. Normative requirements for reporting of adverse drug reactions in clinical trials are defined in Cabinet Regulation No 172, 28 February 2006 "Regulations on Conducting Clinical Trials and Non-interventional studies and Labelling of Investigational Medicinal Products, and Procedure for Conducting Inspections on Compliance with the Requirements of Good Clinical Practice".

    3. More detailed information on e-reporting of adverse drug reactions and E2B implementation status in Latvia can be found on:http://eudravigilance.emea.europa.eu/human/index.asp > E-Reporting to Member States > Latvia

    4. Information about the activities of the Clinical Trial Facilitation Group (CTFG) established by EU Heads of Medicines Agencies and Voluntary Harmonization Procedure (VHP) for assessment of multicentre clinical trials can be found on: Guidance document for a Voluntary Harmonisation Procedure (VHP) for the assessment of multinational Clinical Trial Applications


    Addittional information: 
    http://www.zva.gov.lv/