Key Capabilities

A single integrated team covering medical, operational, regulatory, and laboratory workstreams to accelerate your study.

Medical Writing

Protocols, IB, CSRs, and regulatory documents.

Biostatistics

Statistical analysis plans, sample size, and reporting.

Study Monitoring

On-site and remote risk-based monitoring.

Site Management

Coordinated multi-site activation and oversight.

EC Submission

Ethics committee and IRB submission management.

Archiving

Compliant trial master file and document archiving.

Site Visibility & Selection

Site landscape mapping, feasibility, and qualification.

Medical Monitor

Medical oversight, safety review, and protocol guidance.

Participant Recruitment

Recruitment and retention strategy and execution.

Regulatory Affairs

BPOM and regional regulatory strategy and submissions.

Decentralized Clinical Trials

Remote and hybrid DCT models for broader patient access.

Multi-region Clinical Trial

Coordinated execution across Southeast Asia and beyond.

Ready to discuss your Drugs & Vaccines program?

Our integrated team is ready to design a study tailored to your development goals.