Clinical Trial And Site Management

Trial and site management services performed by experienced mediSMART staff are 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 successful site and investigator selection leads to achievement in the clinical study.
    Based on therapeutic area experiences, the most qualified investigators are selected depending on previous research experiences according to therapeutic areas. Consequently, feasibility visits are performed to get information about their interests on participating clinical studies.

    mediSMART is the only local CRO in Turkey which has a professional investigators pool. Investigators who are interested to participate in a clinical research may apply from our web application form which is aiming to collect information about their clinical research and therapeutic area experiences.
  • Ethics Committee (EC) and Regulatory Authority Submission and Approval Process
    Avoiding any delays during regulatory submission process and getting faster approvals from ECs and Regulatory Authorities are key factors for a clinical study to be initiated in a timely manner especially in competitive global international studies which aim to align all countries on the same level for patient recruitment. Therefore choosing the right EC for faster approval and timely submission is essential for patient recruitment.

    It is obvious that 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. Some responsibilities of mediSMART clinical team under applicable regulations and guidelines are as below:

  • Supporting investigators on study procedures such as screening and randomization procedures to enable them include more eligible patients,
  • Under responsibility of investigators, searching site’s subject database to find out more potential patients,
  • Interacting with referral sites to determine potential subject status
  • Preparing advertisements to speed up patient recruitment.

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:

  • Site Staff Training Including Electronic Data Capture (EDC)
  • Investigator Meeting Organizations:
    • Selection of meeting location,
    • Organization of meeting room for meeting presentations
    • Organization of travels for all participants,
    • Preparation of meeting and training binders
  • Safety Reporting
  • Institution&Investigator Fee Payments Organization which includes preparation and execution of revolving fund agreements between institutions and sponsor.
  • Central & Local Laboratory Organizations.
Services (All)
mediSMART Medical Research LTD Ekinciler Caddesi Elbistan Sokak Pekiz Plaza No: 5 Kat:B2 34810 KAVACIK BEYKOZ İSTANBUL TURKEY
Tel: +90 (216) 404 10 88 Fax: +90 (216) 404 10 87 ,
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