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Quality & Ethics

SMO · Quality & ethics

Quality and ethics at the core of every task

Participants first. Always.

Every procedure we support affects a real person who has chosen to contribute to medical progress. Their rights, safety and wellbeing come before any operational consideration — and the data we help collect must be worthy of their trust.

Our principles

Participant rights & safety

Wellbeing comes first, in line with the Declaration of Helsinki.

Informed consent

A transparent, unpressured consent process led by the investigator team.

GCP-aligned practice

Work aligned with ICH E6 Good Clinical Practice and local regulations.

Data integrity

Records that are attributable, legible, contemporaneous, original and accurate (ALCOA+).

Confidentiality & data protection

Personal data handled in line with Türkiye’s data protection law (KVKK), the EU General Data Protection Regulation (GDPR) and study requirements.

Continuous improvement

Training, feedback and corrective actions that strengthen quality over time.

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SMO · Our commitments

What you can always expect from us

Six commitments that guide our teams — to sites, sponsors, CROs and, above all, to study participants.

  1. 01

    We support investigator oversight — we never present our staff as a substitute for it.

  2. 02

    We never promise recruitment numbers or study outcomes we cannot stand behind.

  3. 03

    We never trade participant privacy for operational convenience.

  4. 04

    We declare and manage potential conflicts of interest openly.

  5. 05

    We encourage every team member to raise quality or safety concerns — without fear.

  6. 06

    We report deviations promptly and transparently to the responsible parties.

CRO · Quality & ethics

Ethics beyond compliance

Quality is not only a documented process — it is a decision-making mindset.

Honest feasibility

We favour evidence-based assessments over ungrounded recruitment promises.

Participant welfare & privacy

Participant rights, safety and data protection inform how studies are supported.

Transparent collaboration

Clear communication about risks, responsibilities and practical solutions.

Hand in a business suit touching glowing buttons labelled Audit, Compliance and Regulation