Investigator Services

CIS provides several essential services for investigators related to the conduct of a clinical research study. CIS will provide support in the following areas to enhance your success and maximize your efficiency when conducting a clinical trial with us. OUR COMMITMENT TO YOU includes: 

Trial Management

• Staff support and training as needed for clinical research coordinators.
• Verification systems for data quality control.
• Assistance with meeting target enrollment goals.
• Database management.

Site Management

• Assist with site specific development of Standard Operating Procedures (SOP's).
• Obtain sponsor statements of indemnification.
• Support quality assurance.

Recruitment and Marketing Management

• Support with advertising and patient recruitment strategies.
• Support with patient retention and database management strategies.
• Community marketing support.
• Support with clinic brand management strategies.
• Website development support.

Site Business Development Program

• Dedicated business development marketing plan soliciting studies on your behalf.
• Notification of upcoming research trials in your therapeutic area. 
• Participate in major professional meeting conventions and conferences.

Regulatory Documentation Support

• Assist in development of source documents as needed.
• Assist with completion and submission of regulatory documents (IRB forms, 1572's, CV's, etc.)
• Aid with study coordination.
• Provide administrative and regulatory support. 

Education

• Facility assessment.
• Developmental training for investigators and staff.
• Work with and interact with the IRB.
• Understanding and complying with FDA, HHS & HIPAA regulations.
• Effective consent process.
• Industry standards (GCP, GLP, GMP).
• Ethics/protection of human subjects.
• Regulatory document assistance.