Clinical monitoring

We provide clinical research personnel and support services to the pharmaceutical, biotechnology and medical device industry. We offer fast, flexible and tailored solutions to our clients with the key advantage of true cost effectiveness.

MKS Research has experience and also pool of potential investigators in many therapeutic fields:

• Cardiology
• Rheumatology
• Oncology
• Respiratory
• Diabetology
• Obesitology
• Orthopaedics
• Haematology
• Gynaecology
• Psychiatry
• Urology
• Pain treatment
• Pediatrics

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 and initiation

Initiation of study site upon complete:

• obtaining all regulatory authority  and central and local ethics committee  approvals
• essential documents collection
• technical support for study-specific systems and devices
• transfer of study specific materials to the site
• training of study staff with respect to their responsibilities for the conduct of clinical trial, protocol review, safety reporting etc.
• training of other study personnel, such as delegated pharmacists, local lab staff, study nurses
• organisation of study drug supply delivery , cooperation with pharmacist
• compilation of Investigator Site File, Trial Master File

Routine monitoring visits

Our team consists of highly qualified CRAs with medical, life science or scientific background who receive continuously further training and education. They conduct ongoing on-site clinical monitoring throughout the trial to make sure that it is conducted, recorded and reported in accordance with the study protocol, ICH GCP and applicable regulatory requirements.

Safety reporting

Our CRAs make sure that the reporting guidelines for Adverse Events and Serious Adverse Events are strictly adhered to.

Close-out visit

Prior to the study close-out, CRA ensures a timely resolution of data queries prior to the database lock, final study drug accountability and IMP return or destruction.

The site is closed after a thorough  review of Investigator Site File is performed to contain all relevant documentation, assessment of regulatory documents, collection of appropriate close-out documents, appropriate archival of trial documentation is ensured.