Clinical Trial And Site Management

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Clinical Trials and site management services performed by experienced mediSMART staff can be shaped under three main titles:

Feasibility Activities and Site Selection:

Study and Research Planning on Patient Population
A successful research starts with a successful planning. It is essential to get right consultancy on planning phase of a clinical research. Therefore mediSMART medical consultants provide consultancy to its business partners.

Investigator Recruitment
A correct selection of site and investigator leads to a successful study.
Based on therapeutic area experiences, the most qualified investigators are selected and feasibility visits are performed to get information about their interests on participating clinical studies.

Ethics Committee and Ministry of Health, Regulatory Authority Submission and Approval Process
Avoiding any delays and managing a smooth process of regulatory submission and approval process is one of the key factors for a clinical study to be initiated on time. Therefore choosing the right Ethical Committee shoul be prefered for faster approval and timely submission.
It is obvious that an experienced and dedicated clinical research team is taking an important role in this process.

Patient Recruitment

It is crucial to reach the targeted patient population in a clinical study in terms of successfully evaluation of study objectives and end points via statistical analyses which will reflect the accuracy of obtained data. Therefore mediSMART clinical team effectively supports study investigators to make them meet with their planned patient recruitment numbers. Clinical team supports the investigators on study procedures such as screening and randomization procedures to enable them include more eligible patients and under responsibility of the investigators, researches site’s subject database to find out more potential patients.

Site Initiation, Periodic On-Site Monitoring and Site Close-Out Activities

mediSMART employees are committed to work under ICH-GCP , applicable local regulations and guidelines as well as mediSMART and Sponsor SOPs regarding all monitoring activities. Site services of mediSMART performed by professional clinical research team also include followings: