For more than 30 years, QST has been supporting Phase I-IV clinical development programs for pharmaceutical and medical device companies. We have executed more than 800 clinical studies in a diverse array of therapeutic areas resulting in more than 78 approvals.
QST is committed to quality, and we understand the critical nature of maintaining regulatory compliance and data integrity. Our Clinical Services team interacts seamlessly with our sponsors, vendors, and the clinical sites to ensure that the programs we execute are conducted efficiently, safely, and cost-effectively no matter how complex your study.
Out clinical services team has been trained on FDA regulations including good clinical practice, ICH guidelines, local regulations, and QST standard operating procedures. Protocol specific training is conducted prior to the kick-off activities of each study conducted.
QST’s program managers and CRAs are experienced in the therapeutics areas in which they work. They are committed to ensuring high quality data collection through proactive communication from the start of the study through study close-out.
- Study management
- Site identification and selection
- Vendor selection and management
- Budget/Contract negotiation
- Investigator meeting planning and conduct
- Plan development
- Site initiation, interim and close-out visits
- Site training
- Ongoing site management
- Patient recruitment and retention
- Source document verification
- Query resolution
- Clinical trial management system
- Drug accountability and safety
- Medical monitoring
- AE/SAE reporting and management
- Regulatory documentation
- Site inspections and FDA audit preparations