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