Argint provides the following services to the pharmaceutical, biotech and medical device industry:

• Feasibility
• Monitoring
• Project Management
• Quality Assurance Audits
• Regulatory & Ethics
• Provision of Study Extranet Sites
• Consultancy
• Contract CRAs

Clinical Operations
Argint has a core team of highly experienced clinical research professionals, most of whom have higher degrees or are medically qualified. Our CRAs are fluent in the following Eastern European languages:

• Bulgarian, Croatian, Czech, Greek, Hungarian, Macedonian, Polish, Romanian, Serbian, Slovenian, Slovakian.  In addition, all of our CRAs are fluent in English.

Regulatory Services
Under the guidance of Dr Eva Halászi, Director of Clinical and Regulatory Compliance, Argint’s Regulatory Services team are able to offer full functional support for all regulatory and ethics submissions in CEE/SEE. The services provided include:

• Preparation and submission of complete packages to meet the local requirements of Competent Authorities and Ethics Committees
• Preparation and translation of core clinical documents including country specific SIS/ICFs
• Preparation and translation of drug labels to ensure compliance with local GMP requirements
• Sourcing of local insurance policies
• Review of documents from external sources to ensure compliance with local guidelines/laws
• Obtaining import licenses for clinical trial materials

Argint can also assume the role of legal representative and/or representative applicant if requested.

Systems
The company has a full set of clinical, regulatory and QA SOPs that enable our employees to conduct studies to ICH GCP and regulatory standards.  Project management systems are in place to allow efficient tracking of study issues via project specific intranet websites. These are used as central storage points for document libraries (with check in/out facilities and built in version tracking) and also allow key project issues to be communicated to the entire study team.