NCRA's Clinical Operations teams are dedicated to providing exceptional service and will:  

• facilitate and assure your trials are conducted under ICH GCP guidelines,

• combine speed, accuracy, efficiency and accountability in all facets of your trial,

• provide CRAs skilled in monitoring and regulatory compliance issues,

• train CRAs to protocol-specific and disease-specific indications,

• provide a Project Manager as a liaison,

• operate under your SOPs, or ours, or we can create customized SOPs,

• assist in IRB affairs and approvals, and

• manage your trial on-time and on-budget.

The services provided by NCRA will vary in accordance with your project-specific needs.  For example, your NCRA team can:

• set-up your trial from investigator recruitment, to pre-trial site qualification visits, to assisting in your contract  negotiations,

• provide protocol writing or review,

• provide CRF development or review,

• assure subject safety and regulatory compliance in IRB affairs,

• train site teams in all facets of the protocol and trial management,

• perform Initiation, Interim Monitoring and Close-Out Visits,

• manage trial supplies,

• manage clinical site payments,

• work to expedite accurate, clean and supportable protocol acquired data,

• assure that complete regulatory documentation is properly collected and archived, and

• perform Quality Assurance Review.

WHATEVER SERVICES YOU CHOOSE, YOU CAN BE ASSURED WE WILL PERFORM THEM WITH SPEED, ACCURACY AND ACCOUNTABILITY.