Feasibility
If you are considering initiating a clinical study in CEE Argint International can conduct a feasibility study for you and present you with a detailed report. We have excellent relationships with key opinion leaders in many therapeutic areas in each country and we provide reliable recruitment predictions. Additionally we can conduct site selection visits to ensure the sites you will be working with are fully equipped and adequately resourced to implement your study protocol.

Regulatory & Ethics
Argint International are able to prepare submission packages to meet the local requirements of Competent Authorities and Ethics Committees in CEE countries and thereby enabling rapid start up of studies in these territories.

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

Additionally our CRAs are experienced in the following regulatory activities:

• preparation and translation of core clinical documents including country specific SIS/ICFs
• review of drug labels to ensure compliance with local requirements
• sourcing of insurance policies
• review of documents from external sources to ensure compliance with local guidelines/laws
• obtaining import licenses for clinical trial materials

Monitoring
Our policy is to select the best CRA candidates and continue to develop their monitoring skills. Our CRAs are fluent in two or more languages (including English) and most have higher degrees or are medically qualified.

Our CRAs are experienced in the following activities:

• collecting essential study documents prior to and during the study
• performing site selection visits
• performing site initiation visits and training of site staff
• monitoring paper based and electronic CRFs and source data verification
• serious adverse event (SAE) reporting and SAE reconciliation
• resolving logistics issues
• drug accountability
• maintenance of study files - site motivation/initiation of recruitment initiatives
• preparation and delivery of accurate status reports
• coordination and tracking of investigator payments
• performing close out visits
• archiving of study files and documents

With Argint CRAs you can be assured that you will have professional representation at every site.

Project Management
The directors of Argint International have many years of international trial management experience and take a personal interest in the progress of every study. 

Using this experience we are able to:

• provide advice to our clients to achieve an optimal result for the study
• assist Argint CRAs in the management of investigational sites
• assist Argint CRAs in resolving regulatory and logistics issues
• assist Argint CRAs and clients in the set up of project management tools
• assist Argint CRAs and clients in the preparation of effective study processes and procedures
• assist Argint CRAs and clients in the management of study vendors
• ensure quality is maintained and SOPs are adhered to across all study activities

Argint International has a full set of clinical and regulatory SOPs that enable Argint employees to conduct studies to ICH GCP and regulatory standards. 

In addition Argint has introduced IT systems based on MS Infopath forms and MS Sharepoint Services.  Key SOP forms were created in MS Infopath and this enables Argint management to export the data directly from the forms to status reports created for our clients.   MS Sharepoint enables Argint to create project specific intranet websites.  These are used as central storage points for document libraries (with check in/out facilities and built in version tracking), contacts lists, study task lists and allow key project issues to be communicated to the entire study team.

Contract CRAs
Sponsor companies and CROs require additional CRA resource from time to time dependant on project status and the development plan for a product.  Argint International is able to provide short-term or long-term subcontracted CRAs to supplement your own project teams.  CRAs are carefully selected for each assignment to ensure your project needs are met.  Regular ‘face-to-face’ meetings with Argint management take place to further enhance Argint’s support of your project.

Consultancy
The directors of Argint International have previously been asked to assist clients in consultancy roles both as ‘trouble-shooters’ for projects being conducted within CEE and in general business activities, such as assisting companies establish a presence in CEE.  We are happy to provide advice and guidance to clients in our areas of expertise.