Application for Support of Clinical Program

Vigiland is experienced in study-related activities in various fields within clinical research. Vigiland is able to cover projects from the pre-study–start-up phase to study closure, including post-study activities, with administration, monitoring and programlifecycle management. Furthermore, Vigiland has experience in ensuring and auditing compliance of the specified study activities and auxiliaries, such as regulatory reporting, not limited to the territory of Hungary. Vigiland provides a person or whole team for the required position with 8 years of experience in clinical research.

Study protocol
In addition, Vigiland has the experience in establishing-writing / reviewing study protocols for local studies including relevant documentation, such as Case Report Forms, and Adverse Event Reporting Forms.

Monitoring
The monitoring team members have more than 8 years of experience in clinical research, with university degrees in either medicine or pharmacy. Their experience covers almost all therapeutic areas, such as numerous fields of internal medicine, CNS studies, oncology and also less “popular” areas such as dermatology, gynaecology and ophthalmology.

Audits (GCPandGVP)
Vigiland is able to perform compliance monitoring of the sites, with external partners both in-house and on site, horizontal or longitudinal.

Safety support

• Support adverse events reporting

• Provide medical assistance for handling serious adverse events

• Provide safety training for sites

• Ensure preparation and reporting of the Adverse Event Report on site

• Ensure Adverse Events recording

• 24/7 surveillance

Auxiliary activities
Vigiland manages several activities which includes a complete set of services for organizing investigators' and personal teammeetings.

Lifecycle Management

• Support for our Partner's clinical programs

• External contacts, oversight of the team work and providing and organizing training where necessary

• Support for clinical strategies in the planning phases of clinical programs

• Support for regulatory submissions

• Ensuring that activities of all parties are managed collaboratively, efficiently and effectively  Ensuring documentation processes and related activities

The colleagues
The Vigiland colleagues are the most important element of our work quality. Our experts have

• Proven experience in clinical research (clinical experts, line managers, study managers, monitors, safety assistants with knowledge of budgeting, resource planning, performing interim and final evaluations, and monitoring regulatory compliance

• Excellent knowledge of the regulatory background of clinical studies

• Excellent teamcommunication skills

• Excellent leadership decision making ability

• Excellent problemsolving skills

• MD and PharmD professionals

• Excellent spoken/written English

• Willing to travel within or outside of Hungary