Quality built into how we work, not added afterwards

Our framework is designed around the international and Indian standards that govern clinical research. We describe what we follow, and we don’t claim certifications we don’t hold.

ICH-GCP E6(R3)

Our processes follow the principles of the ICH E6(R3) Good Clinical Practice guideline, including its risk-based, proportionate approach to quality and its emphasis on participant rights, safety and data reliability.

Protocol-specific risk review at site start-up
Investigator oversight of delegated tasks
Reliable, ALCOA+ source records

New Drugs and Clinical Trials Rules, 2019

Site activities are planned around CDSCO’s NDCT Rules 2019, including ethics committee requirements, informed consent and serious adverse event reporting timelines.

Approvals from registered ethics committees
Audio-visual consent recording where required
SAE reporting support within regulatory timelines

Data privacy: DPDP Act 2023

We handle personal data of participants and staff in line with India’s Digital Personal Data Protection Act, 2023, alongside sponsor and protocol requirements.

Purpose limitation and data minimisation
Role-based access and confidentiality undertakings
Documented breach response process

SOPs and training

Written standard operating procedures cover every service we offer. Staff are trained on SOPs, GCP and each protocol before they work on a study.

Controlled SOP index with version history
Training matrix and GCP certificates on file
Deviation, CAPA and internal QC processes

Draft note: list any formal certifications or accreditations here only once they are actually obtained.

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