CLINICAL TRIAL SERVICES

Cro/ Training Services
  • ICH-GCP training
  • Basic CRA and clinical trial specialist training (workshop practice)
  • Biostatistics Training
  • Research budgeting and process management training
  • Time management, managerial skills and leadership training

  • Cro/ Training Services (Click for details)
  • Cro/design and Regulatory Services
    • Standard Operating Procedure development and provision of required counseling in this regard,
    • Supply of site and system audit counseling and recruitment of personnel for the preparatory steps,
    • Preparation, Submission and monitoring for Approval of Application Dossiers for submission to Ethics Boards-Ministry of Health
    • Design and implementation of drug studies, observational studies, medical device studies, pattern studies, pharmacoeconomics studies, and early access programs,
    • Designing of study protocols, synopses, concept sheets, patient registration forms, surveys, and informed consent forms,
    • Preparation and process management supporting material for studies (e.g. guidelines, patient cards, physician information cards, booklets, newsletters, e- bulletins, etc.)
    • Improvement of study systems of quality control through the monitoring of all studies

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  • Cro/ Organizational Services
    • Carrying out of feasibility procedures and preparation of feasibility reports for the studies,
    • Arrangement of organizations or special investigational centers in clinical trials, process follow-up, and domestic and overseas transfer of samples,
    • Receipt and delivery of any third party payments; follow-up of materials
    • Process follow-up for the import and customs proceedings of pharmaceutical products
    • Organization of patient support and transfer procedures

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  • Cro/ Recruitment Services
    • Supporting services for site coordinators (recruitment, management, and payment arrangements)
    • Data input support personnel recruitment
    • Hiring of clinical trial monitors
    • Hiring of clinical trial assistants
    • Hiring clinical trial nurses

  • Cro/ Recruitment Services (Click for details)
  • Cro/ Trial Management Services
    • Project Management
    • Site management
    • Investigator Meeting Planning and Coordination
    • Site-Specific File Management
    • Clinical trial documentation (storage of materials from completed studies)
    • Carrying out of the retention and destruction procedures for returned clinical research materials

  • Cro/ Trial Management Services (Click for details)
  • Cro/ Data Management and Analysis Services
    • Calculation of sample size
    • Database preparation
    • Preparation of database management plans
    • Generation of data input and output systems (double input)
    • Query systems and clean data preparation
    • Statistical analysis
    • Interim analysis
    • Preparation of clinical study report
    • Electronic study designs
    • Definition of validation procedures and electronic study designs in accordance with international guidelines

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  • Cro / Other Services
    • Large-scale Field Studies; Regional sample size design
    • Surveyor training and pilot survey application
    • Collecting of necessary samples and pilot survey application
    • Patient calls (call center)
    • Social research
    • Studies of the department of medical associations and public health
    • Preparation and execution of the application files for university support and grant projects (TUBITAK, ARDEB etc.)
    • Regulatory Authority Submissions (all submissions of the relevant clinical trial department are carried out and charged by our company on monthly basis)
    • Setup of electronic order portals, follow-up of product stocks, and preparation and submission of the required reports

  • Cro / Other Services (Click for details)