Services
We offer a wide range of services, skills and expertise to all our clients. Some are listed below, but we are able to tailor our services to suit your needs
Study documentation
Writing study protocols and designing Case Report Forms
Preparation of Ethical Committee submissions
Safety monitoring and pharmacovigilance
Preparation of Data Management Plans, Monitoring guidelines
etc.
Investigational site monitoring - phase II-IV
Monitoring of clinical trials to ICH-GCP standards and Standard
Operating Procedures (pre-study
visits, site initiation, ongoing monitoring and closeout)
Overall point of contact for Investigators Liaison with site personnel regarding all study issues Explanation and resolution of clinical data queries with staff
Coordination of tasks with clients and other team members
Arranging drug supply, delivery and returns
Data management
Planning database structure, verification and validation checks
Collection of study data and entry to database
Preparation and updating database queries
Other services provided
Study management - design, management and implementation from
start-up to completion Training and support of clinical teams /
site staff as necessary
Selection of potential investigators and study sites in the UK
and Europe Performing feasibility visits in the UK and Europe
Arranging transportation of biological samples with specific
requirements Presentation at Investigator and team meetings
Review of procedures, reports and clinical trial documentation
performed by clients / CROs
Assistance with Audit preparation
We have conducted feasibility visits, monitoring and various support tasks in the following countries: United Kingdom, Ireland, The Netherlands, Sweden, Finland, Turkey
and Portugal
