Early Access Programme Applications and Management
We provide end-to-end solutions covering TİTCK submissions, approval processes and programme management for Early Access Programmes (EAP — Compassionate Use, Named Patient Programme) that enable patients with serious or life-threatening conditions and no alternative treatment options to receive medicines that are not yet licensed in Türkiye or are used outside their licensed indication.
Scope of Our Service
- Preparation of Early Access (Compassionate Use) application dossiers
- Submission to TİTCK and related authorities, and process follow-up
- Coordination of Ethics Committee applications where required
- Establishment of patient eligibility criteria
- Coordination between sponsor, physician, pharmacist and patient throughout the process
- Management of drug supply, customs clearance, distribution and site logistics
- Execution of pharmacovigilance (adverse event reporting) processes
- Reporting and documentation management throughout the programme
- Management of programme closure and termination procedures
Our Services
- Project Management and Clinical Trial Conduct
- Ethics Committee and Ministry of Health Applications
- Study Coordinator
- Contract Personnel
- Clinical Trial Document Provision
- Data Entry / Management
- Pharmacy and Medical Device/Supply Provision
- Clinical Trial Supply Management
- Customs Services
- Consultancy Agreement Preparation and Follow-up