Technology

1. 1

   Designed per study

   Before any data is collected, the manufacturer and Medex CRO define the study plan: objectives, endpoints, follow-up schedule, participating clinics and the approvals required, including the ethics committee and, where applicable, TİTCK. AIDA’s implant form is configured to that plan; its default follow-up template of one week, eight weeks and eighteen months is a starting point, not a standard for every study.

2. 2

   Documented and exported with consent

   In AIDA the dentist records the implant’s reference and lot, risk factors, bone quality, loading and the follow-up visits; the patient’s research consent is signed on screen. Only the forms of consenting patients are exported, once a month, as a single file encrypted so that only Medex, which holds the private key, can open it. The clinic itself cannot read the file, and every export is written to the audit log.

3. 3

   Checked, analysed, reported

   Medex CRO checks data quality against the plan, analyses the data and prepares the post-market clinical follow-up report and clinical evaluation the manufacturer needs under EU MDR. Responsibilities between manufacturer, clinics and Medex CRO are set out in the study agreement.

The export contains no names, national ID numbers, phone numbers or addresses. Patients are represented by a case code; initials, age and sex remain, so the data is pseudonymised, not anonymous.