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Clinical Research Organization

Site Selection and Feasibility

Feasibility study is one of the key factors for success of a clinical trial. CROMNIA has a comprehensive site selection and feasibility strategy to avoid any risks, including:

  • Investigator’s interest
  • Number of eligible patients expected to be recruited
  • Recruitment and retention in previous clinical trials
  • Study experience and training of site personnel
  • Trial-required facilities and related equipment
  • Clinical and Observational Trial Management

    CROMNIA has experienced staff to effectively manage a clinical trial on time and on budget with success, and provides the following services:

  • Investigator contract
  • Site initiation
  • Clinical monitoring
  • Trial Master File management
  • Vendor management
  • Drug distribution management
  • Close communication and cooperation both with study site and customer
  • Support to investigator for patient enrollment
  • Regulatory Affairs

    CROMNIA team is highly experienced on regulatory affairs to be performed for a clinical trial regarding:

  • Approval for the conduct of a clinical trial from Regulatory Authority (MoH) and Local Ethics Committees (LECs)
  • Interaction with MoH and LECs to seek advice and agreement
  • Clinical monitoring
  • Obtaining permissions of the customs committee to import/export investigative product (IP), biologic specimens and medical equipment
  • Making organization and obtaining permissions to destroy remaining IP
  • Reporting to MoH and LECs
  • Medical Writing

    In collaboration with investigators and scientists in all therapeutic areas, and with other subject matter experts, the physicians of CROMNIA have skills for medical writing including:

  • Protocol writing and development
  • Statistical activities
  • CRF design
  • Informed Consent design
  • Final study report
  • Documentation for congress exhibits (abstracts, posters and papers, etc.)
  • Site Coordinator Services

    CROMNIA provides study coordinator for supporting the sites in terms of:

  • Completion of CRFs
  • Management of laboratory samples
  • Drug accountability
  • Trial Master File tracking
  • Follow-up of queries and issues to be resolved on time
  • Temperature control and record
  • Preparation for monitoring visits and audits
  • Medical Translation

    All members of translation team of CROMNIA are physicians and have professional experience to provide on-the-date and precise medical translation required for the conduct of a clinical trial

    Investigator Meeting Organization

    Investigator Meeting is an important trial-related event offering an ideal occasion for the study team to get acquainted with each other and to overview the trial-specific procedures prior to initiation of the study. CROMNIA organizes Investigator Meetings and provides the following services:

  • Overall organization and supervision at various venues
  • Travel arrangements, accommodation and entertainment
  • Training of study team for specific studies
  • Presentations and tutorial materials
  • Translation / Interpreting
  • is a member of SAKDER