AXONCRO LLC

AXONCRO
As a Contract Research Organization (CRO), AXONCRO provides high-quality services in the planning, conduct, and management of clinical trials, fully compliant with national and international regulations and based on ethical principles, with its expert and experienced team.

CLINICAL RESEARCH SERVICES

• Selection of suitable sites and investigators

• Management of site initiation, monitoring, and close-out processes

• Preparation and submission of study progress reports

• Safety reporting and pharmacovigilance follow-up

• Management of Ethics Committee and Ministry submission/approval processes

• Design, preparation, and distribution of study newsletters

• Organization of training programs for monitors (CRA) and investigators

• Planning and organization of investigator meetings

• Provision of site coordinators and support staff

• Site management and coordination services

• Preparation and management of clinical trial documentation

• Preparation and support for audits and inspections

• Management of quality assurance and compliance processes

• Data management and electronic system support

• Logistics and drug/device supply chain management

• Post-study archiving and reporting services

• Medical device rental and maintenance services

DATA MANAGEMENT SERVICES

• Accurate, complete, and timely entry of study data into the system

• Coordination and management of data entry centers

• Quality control and auditing of data entry processes

• Recruitment, training, and employment of qualified data entry personnel

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

• Ensuring data integrity, confidentiality, and security

• Support for Source Data Verification (SDV) processes

• Compliance with national and international regulations in data management

MEDICAL WRITING & TRANSLATION

• Preparation of statistical reports for clinical research

• Development and writing of study protocols

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

• Writing of abstracts, articles, and conference papers for scientific journals

• Editing and language review for abstracts, articles, and papers

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

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

• Preparation of interim reports and final clinical study reports

• Preparation of safety reports (DSUR, PSUR, etc.) and pharmacovigilance support reports

• Preparation of SUSAR/SAE summary tables

• Writing, summarizing, and translating Investigator’s Brochures

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

• Development of CSR (Clinical Study Reports) and CTD (Common Technical Document) documentation

• Preparation of regulatory-compliant dossiers (EMA, FDA, TİTCK, etc.)

• Statistical and writing support for meta-analyses and systematic reviews

• Literature searches and bibliographic support

• Development of publication strategies and scientific communication consultancy

RESEARCH MANAGEMENT

• Planning, conduct, and management of 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 patient registry management

• Planning and reporting support for Health Economics and Outcomes Research (HEOR)

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

• Project management for combination product studies (drug + medical device)