J. Tyson & Associates, Inc.

J. Tyson & Associates, Inc. is a full service CRO. Some of our key service deliverables are listed below for your review. The list below is not comprehensive; therefore if you require a service that is not listed below, please call us direct to discuss. Upon request, JTA will provide you a proposal based on your specifications for work effort. JTA also provides quick response proposals for new sponsors as an aide to secure proper funding for planned clinical trials with investment dollars

Monitoring Services

• On-site monitoring for device, drug, vaccine, IVD and biologic trials, phase I through IV, multicenter or single center for any type of monitor visit
• Off-site monitoring for any type of trial
• On-site monitoring outside the USA
• Site selection
• Project management
• Site management

Training Services:

• Site personnel, protocol specific
• Site personnel, preparation for specific type trial work or regulatory bodies review
• Site personnel, preparation for study trial site set up and general start up procedures
• Site SOP development, implementation and training programs
• Sponsor or CRO employee/consultant training

SOP Development:

• Sponsor or CRO employee/consultant training
• SOP development, implementation and maintenance
• SOP development for outside US sites

Regulatory Document Development:

• Informed consent development
• Contract document development
• Budget development
• Master File Set-up and Maintenance
• Site document preparation towards "GO" Status
• Document system security system development and implementation

Other Services:

• Protocol development
• Clinical Operations Plan
• Data Preparation Plan
• Vendor selection and contracting
• Investigator meeting set up and implementation
• Site and vendor audit
• Medical writing
• Test article storage, shipment, tracking and accounting
• Consulting on specific issues
• Rescue services
• Internal process review