OUR SERVICES

• Selection of appropriate centers and researchers

• Management of the start-up, monitoring and closing processes of centers

• Preparation and presentation of progress reports regarding the research process

• Monitoring of safety reporting and pharmacovigilance processes

• Carrying out the Ethics Committee and Ministry application and approval processes

• Design, preparation and distribution of study bulletins

• Organizing training programs for CRA and researchers

• Planning and organization of researcher meetings

• Employment of field coordinator and support staff

• Central management and coordination services

• Preparation and management of clinical trial documentation

• Preparation and support for audit and inspection processes

• Execution of quality assurance and compliance processes

• Data management and electronic systems support

• Logistics and pharmaceutical/device supply chain management

• Post-research archiving and reporting services

• Medical Device Rental and Maintenance Services

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Data Management Services

• Entering research data into the system accurately, completely and on time

• Coordination and management of data entry centers

• Quality control and auditing of data entry processes

• Selection, training and employment of qualified data entry personnel

• Technical and operational support for Electronic Data Collection (EDC) systems

• Ensuring data integrity, confidentiality and security

• Support for the verification (SDV) processes of system data with source documents

• Compliance with national and international regulations in data management processes

• Preparation of statistical reports for clinical research

• Development and writing of research protocols

• Preparation of Informed Consent Forms (ICF) and patient information documents

• Writing abstracts, articles and papers for scientific journals

• Proofreading and language checking for journal abstracts, articles and proceedings

• Translation of scientific documents (articles, abstracts, research brochures, etc.)

• Preparation of graphics, tables and visual materials for publications and presentations

• Preparation of interim and final clinical study reports

• Safety reports (DSUR, PSUR, etc.) and pharmacovigilance support reports

• Preparation of SUSAR / SAE summary tables

• Investigator's Brochure writing, summarizing and translation

• Preparation of bulletins, posters and presentation materials for clinical research

• Preparation of CSR (Clinical Study Report) in clinical research and documentation in accordance with CTD (Common Technical Document) format

• Preparation of dossiers in compliance with regulations (EMA, FDA, TITCK, etc.)

• Statistical and writing support for meta-analysis and systematic review reports

• Literature review and bibliographic support

• Publication strategy development and scientific communication consultancy

• Planning, conducting and managing medical device clinical trials

• Design, implementation and reporting of observational drug studies

• Planning and management of retrospective studies

• Coordination and management of Phase I–IV clinical trials

• Organization of bioequivalence and pharmacokinetic studies

• Real-World Evidence (RWE) studies and management of patient record systems

• Health economics and outcomes research (HEOR) planning and reporting support

• Conducting post-marketing observational studies (PMS) and safety follow-up studies

• Project management for combined product research (drug + medical device)