SERVICES

 

LEGE ARTIS core services may be combined into the following groups:

• Clinical research;
• Medical services;
• Regularity services and logistics;
• Quality assurance and quality control.

Please see more about each service on the corresponding web page. In a few words, LEGE ARTIS is aiming to reach operating excellence in every project by understanding and satisfying the expectations and requirements of our clients.

 

Our Clinical Operations department provides a complete array of integrated services through Phase I to IV of clinical research.

Our Medical department executes responsibilities related to medical aspects of clinical trial processes, procedures and documentation, trial-related medical decisions, and medical care of trial subjects.

We bring unique local knowledge and specialized staff expertise together to enable the conduct of clinical trials in sophisticated regulatory environment and complicated logistics.

We work in strict adherence to study protocols, ICH GCP guidelines, SOPs, EMEA and FDA regulations preserving high ethical standards. We assure our staff is aware of all applicable professional and legal guidelines for conducting clinical research through regular training.

Supplementary services are implemented with thorough understanding of local needs: Site management, Archiving, Temporary personal, and Central Pharmacy services.

 

LEGE ARTIS has developed a comprehensive set of Standard Operating Procedures (SOPs) that regulate the company activities in each area specified below:

• Management of Company SOPs;
• Company Administration;
• Information Technologies and Information Security;
• Clinical Services; Medical Services;
• Regulatory Services and Logistics;
• Quality Assurance and Trainings;
• Management of Investigational Product;
• Safety Reporting;
• Clinical Trial Documents Maintenance.

LEGE ARTIS SOPs are based on strict adherence to the International Conference on Harmonization (ICH) guidelines and the US, European and local regulations.