Caerus

Caerus is an Australian Contract Research Organization (CRO) and Consulting company offering its pharmaceutical, biotechnology, cosmetics and medical device clients high-quality and wide-range of strategic consulting services and clinical research support within the growing Asian market.

Caerus offers a broad range of services including clinical, regulatory and therapeutic expertise.

Caerus has a dedicated team of highly qualified staff with a combined experience of 30 years in clinical research, devices, drug/device safety, regulatory and medical affairs.

Services

Strategic Consulting
Clinical Trials
Data Management and Biostatistics

Drug/Device Safety
Medical Writing
Audits

Training

Strategic Consulting

Overall Program Support
Clinical Development Plans
Representation to Regulatory Agencies
Advisory Board Selection

Clinical Trials

Project Planning and Feasibility
Project Management
Protocol and CRF Development
Investigator and Site Selection
Investigator Meetings
IEC/IRB and Regulatory Submissions
Clinical Trial Monitoring
Medical/Safety Monitoring
GCP Audit Preparation and CAPA Management

Data Management and Biostatistics

Case Report Form Review
Project Management
Data Management Strategy
Database Design and Development
Data Entry/Coding
Data Validation and Verification
Sample Size and Power Calculation
Statistical Analysis and Reporting

Drug/Device Safety

Adverse Event Reporting
Set-up of Drug Safety and Device Vigilance Processes
Literature Review
Risk Management Plan
Audit Preparation and CAPA Management

Medical Writing

Protocols
Clinical Trial Reports
Journal Article Writing/Publications
Transcription
PSUR
SOPs

Audits

GCP
Pharmacovigilance

Training

ICH-GCP
Pharmacovigilance
Therapeutic Area Expertise