Participant rights & safety
Wellbeing comes first, in line with the Declaration of Helsinki.
About Us
One group. Four specialised divisions.
Bpharma
Site Management Organisation
Bpharma
Clinical Operations
Bpharma
Regulatory strategy, licensing & lifecycle
Bpharma
Pharmacovigilance

SMO · Quality & ethics
Participants first. Always.
Wellbeing comes first, in line with the Declaration of Helsinki.
A transparent, unpressured consent process led by the investigator team.
Work aligned with ICH E6 Good Clinical Practice and local regulations.
Records that are attributable, legible, contemporaneous, original and accurate (ALCOA+).
Personal data handled in line with Türkiye’s data protection law (KVKK), the EU General Data Protection Regulation (GDPR) and study requirements.
Training, feedback and corrective actions that strengthen quality over time.

SMO · Our commitments
Six commitments that guide our teams — to sites, sponsors, CROs and, above all, to study participants.
We support investigator oversight — we never present our staff as a substitute for it.
We never promise recruitment numbers or study outcomes we cannot stand behind.
We never trade participant privacy for operational convenience.
We declare and manage potential conflicts of interest openly.
We encourage every team member to raise quality or safety concerns — without fear.
We report deviations promptly and transparently to the responsible parties.
CRO · Quality & ethics
Quality is not only a documented process — it is a decision-making mindset.
We favour evidence-based assessments over ungrounded recruitment promises.
Participant rights, safety and data protection inform how studies are supported.
Clear communication about risks, responsibilities and practical solutions.
