synCRO is a contract based research organization (CRO) providing services for the setup, conduct and management of clinical studies in Romania, Hungary and Republic of Moldova.

The management strategy of Syncro is focused on developing its activities in the field of clinical studies, ensuring the durability of the organization and the compliance with legal and regulatory, as well as customer / sponsor and supplier requirements.

Syncro emphasizes the understanding of current and future needs of its customers, therefore ensuring that customer requirements and expectations are identified, fully understood and satisfied, in order to raise customer satisfaction.

Our organization guides its activities according to its own QMS documents, including a set of standard operating procedures (SOP). However, Syncro shall comply with SOPs from the sponsor if there is an express request to that. The specifications detailed in the contract with the sponsor shall be respected with priority.

In case Syncro is contracted to perform clinical studies according to SOPs from the sponsor, the employees of Syncro shall become familiar with these standard operating procedures prior to beginning work on the project. The employees who are appointed to a specific clinical study are selected according to their qualification, taking into account their relevant training and experience for the respective clinical study.

 

An essential requirement for the position of CRA is a life-sciences degree (eg. medicine, psychology, nursing, etc.), advanced English and certification of GCP knowledge.


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Services

  • Study budgeting, feasibility, site recruitment

    SynCRO has its own database with qualified investigators in all major therapeutic areas from Romania, Hungary and Moldova.

  • Regulatory affairs, ethic committees

    + Preparation of documents and submission to regulatory authorities and ECs
    + Timely reporting of SUSARs, SAEs.

  • Drug import, site initiation

    + Drug import and distribution to centers
    + Site initiation / training of investigators

  • Project management, study coordination, monitoring

    + Trial site management / site supplies (laboratory kits, CRFs)
    + Continuous assessment of investigators' compliance with GCP / regulatory requirements

  • Clinical Data Management and Biostatistics

    Syncro is providing Clinical Data Management and Biostatistics services through it's partner, AdWare Research.

    AdWare Research was established in 1997 and it is a dynamically developing pre-clinical and clinical data-management and biostatistics provider company. AdWare provides its service in compliance with the national and international regulations, and possesses the relevant GLP, RA certificates.
    Its main activities are:

    + Data-management and biostatistics
    + Quality assurance
    + Independent audit
    + Education and consultancy

    With its strategic partners AdWare can undertake whole-scale project management.
    The data-management services are provided by its own developed Mythos data-manager software that fulfills the criteria of FDA CFR 21 part 11.
    For more information please visit: www.adwareresearch.com

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