MK Research

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

MKS Research team is experienced in:

  • 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

Feasibility/Site selection

By taking advantage of our extended knowledge of local market and  specific issues in the particular environment we offer identification of capable, reliable sites which can adhere to ICH GCP and all applicable legal requirements.

Our pool of potential investigators in many therapeutic areas offers selection of sites which achieve their commitment to subject recruitment.

Study site set up

  • obtaining all regulatory authority  and central and local ethics committee  approvals
  • essential documents collection
  • organisation of study drug supply delivery , cooperation with pharmacist
  • compilation of Investigator Site File, Trial Master File

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.

ruceSite 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.


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.

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MK Research