AI-Supported CRO Services

Regulatory tracking and impact analysis — Monitoring changes at TİTCK, EMA and FDA and assessing their impact on your studies

Protocol, ICF and CRF preparation — Template-based protocol writing in a four-stage flow; informed consent form and case report form design

Document quality control — Reviewing your existing documents for regulatory compliance, terminology consistency and internal contradictions

Ethics committee and ministry submissions — Preparation of submission dossiers and pre-submission checks

Contract and budget support — Preliminary review of CRO-sponsor and hospital contracts, financial assessment

Statistical planning — SAP writing, sample size and power analysis calculations

Protocol and ICF medical review — Assessment of your study documents for medical consistency and patient safety

Safety assessment — Medical evaluation of SAE/SUSAR records, causality analysis and safety signal detection

In-depth literature research — Sourced scientific summaries and decision-support notes across PubMed, ClinicalTrials.gov and other databases

Oncology and advanced therapy expertise — Scientific assessment in precision oncology, CAR-T, NK cell therapy and gene therapy

Drug safety analysis — Drug-drug interaction checks, adverse event analysis and safety profile assessment

Inspection readiness — Checklists for internal and external audits, gap analysis and mock inspection support

CAPA and deviation management — Root cause analysis, corrective and preventive action planning and effectiveness tracking

SOPs and quality documents — Writing and revision tracking of GxP-compliant procedures and forms

Regulatory compliance checks — Compliance assessments under 21 CFR Part 11, ISO 13485, MDR, GDPR/HIPAA

Vendor and site assessment — Assessment frameworks for CRO, laboratory and vendor audits