临渴掘井
“Dig the well before you are thirsty”
– Chinese Proverb
Study Design:
Risk Management is an integral part of any clinical trial. At CSC we believe in taking a proactive approach to the management of risks by ensuring mitigation plans are interwoven to the foundation of our study designs. Our Medical Affairs team works closely with other departments’ in-house experts – as well as an extended network of local KOL and Consultants – to ensure our design methodology and operationalising of studies increases success while considering the financial constraints.
“How do we localise our Protocol Design?”
“Can we use our Global Protocol/CRF in China?”
“How do we ensure our study design works with local clinical practice?”
Beyond study design, our Medical Affairs team can help create other Essential Documents such as CRF, ICF, Patient Diaries, etc., using these same methodologies.
Clinical Study Reports (CSR) & Publishing
Our in-house experts have ample experience producing clear, concise, and professional presentations of study findings – an important part of any development program. We can help you ensure accuracy and uniformity while maintaining full compliance with ICH (International Council for Harmonisation) and other regulatory requirements.
Medical Monitoring:
Our Medical Monitors are skilled clinical development professionals and are strategically located across the country to allow close and timely assistance to participating sites and investigators.
Our medical leaders know most study challenges are unique. Such knowledge only comes from significant experience managing and monitoring trials across a range of therapeutic areas. Our focus is on the solutions.
How we can help:
- Regulatory, Medical & Clinical Strategy Support
- Medical Writing
- Medical Translation
- Trial-Specific SOP Development
- Protocol Design
- CRF Design
- IB Design
- All other Essential Documents
- Study Training
- Medical Monitoring
