Services
Budget and Contract Negotiation
Budget and Contract Negotiation
Budget and Contract Negotiation
o Based on our experience and tools, PRS will assist to project your cost and help you negotiate your budgeto Execute contacts under the authority of the Site Director or Principal Investigator (PI)
Regulatory Management
Budget and Contract Negotiation
Budget and Contract Negotiation
o Coordinate and prepare regulatory submissions while maintaining the regulatory binder throughout the course of the study
o Correspond with local, central or in-house institutional review boards (IRB)
o Track communications
o Provide regulatory guidance and updates
Staff Training
SOP Development
SOP Development
o ICH/GCP Training for clinical research staff and investigators
o Protocol-Specific Training (Investigator/Initiation Meetings)
o CRC/CRA online training
o Periodic Review of SOPs and training of any modification
o IATA Hazardous shipping training
SOP Development
SOP Development
SOP Development
o Create, implement, and uphold standard operating procedures (SOPs) for trial execution
o Modernize current SOP
o Determine the SOP needs and assign local responsibility for management and review
o Clinical quality assurance