Data management
Data management is a key element of any clinical trial. Appropriate data management is critical in providing valuable and solid data. We manage data via our subcontracted vendor company, while fully complying with the GDPR regulations. Appropriate data management is critical in providing valuable and solid data. We manage data via our subcontracted vendor company.
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Site & Investigator contract negotiation
We support our clients in budget development and negotiation and in the process of contracting investigational sites as well as investigators.
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Regulatory services
To meet our customer needs, we assist them in defining the study type (based on the type of investigational product and interventions), discuss the planned submission strategy with the competent authority, prepare the documents essential for submission to the relevant authorities and the ethics committee, while ensuring due diligence of the entire process in order to obtain the approval for the clinical trial conduct within the time frames specified by law.
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Study feasibility
We check thoroughly the feasibility of any kind of clinical trial in Hungary. Our extensive experience and a vast network of investigators help us to assess the real possibility of study sites to recruit patients.
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Medical writing
As a company dedicated to comprehensive planning and organization of clinical trials, we offer preparing documentation that is essential to conduct clinical research trials. We offer flexible solutions, working with experienced medical writers in various therapeutic areas.
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Overall Clinical Trial Management
We are proud to have highly qualified project managers and clinical research associates with university degrees in medical and life sciences. Our colleagues are continuously trained, up-to-date in local regulations and strictly adhering to the deadlines.
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