Clinical trial management

Our clinical trial management services include regulatory affairs, project management, site management, safety and quality monitoring for phase I, II, III and IV trials. We assist our clients in establishing and maintaining study milestones and deadlines throughout the conduct of the clinical trial.

Regulatory Authority and Ethics Committee

• preparation and completion of packages for Regulatory Authority and Ethics Committee submission
• application to the national Regulatory Authority and Ethics Committees
• regular contact with RA/EC throughout the study

Site contracts

MKS Research provides complete site contract negotiations based on sponsor-approved budget as well as tracking, oversight and execution of payments to the clinical trial sites.

Site management

Our team of skilled CRAs closely monitors  study conduct and assists continuously  site staff members, including investigators, nurses and coordinators with study administration, CRF completion, Investigator Site File updating, laboratory procedures, query resolution etc.

A smooth supply of study materials is ensured.

All issues are resolved as soon as possible without affecting course of the trial.

Translations

We provide top quality translations of clinical trial documents for favourable price.

In case certified translation is needed, we use reliable certified translators who can guarantee high quality translation of medical or pharmaceutical text within few days.