• Data Coordinating Centers
• Study Design
• Data Capture & Management
• Site Training & Coordination
• Statistical Analysis & Reporting
• Regulatory Affairs
• Study Logistics

• Facebook
• Twitter
• Linkedin
• YouTube
• RSS Feed

Site Training and Coordination

We are a leader in site initiation, development of protocol manuals, site training, and oversight of study implementation. As a coordinating center, we have over 30 years of experience coordinating and monitoring the work of on-site data collectors, such as clinical center staff and laboratory personnel, who are participating in a multicenter study. We also offer assistance in obtaining institutional review board (IRB) approvals and in the tracking and banking of biological specimens.

Development of the Manual of Operations

We work with study investigators to develop study protocols, study forms, and detailed manuals of operations (MOO). Our researchers are well versed in the development of MOOs, including network policies as well as standards for data management and quality control. We provide detailed instructions on patient enrollment, data collection procedures, and reporting requirements. The MOO describes each data item with an explanation of how the item should be answered and coded. Instructions for handling and labeling biospecimens also are included, as well as methods for preparation and shipment.

Site Training

We develop training materials and conduct training sessions, covering topics such as Good Clinical Practice, adverse event reporting, and other regulatory and quality assurance topics, as appropriate. We offer comprehensive training and certification programs that center on protocol-specific procedures. We provide in-person, teleconference, Web conference, video conference, and computer-based training. The RTI team collaborates with study investigators to develop the training materials that address clinical and laboratory activities, while taking the lead for such areas as recruiting, enrollment, randomization, and Web-based data collection.

Oversight of Study Implementation

We understand that a well-conducted multisite study needs to assure collaboration across sites, along with standardization and uniformity of procedures, to yield high-quality data. We tailor monitoring and clinical oversight support to meet each client's specific needs. Our expertise in oversight of study implementation includes conducting site monitoring visits; verifying required manuals at sites (protocol, manual of operations, policies and procedures, etc.); reviewing site regulatory file(s) and standard operating procedures, enrollment practices and patient retention, data collection, and pharmacy and laboratory procedures; and managing adverse events. We monitor compliance with federal regulatory requirements, track biospecimens and experimental drug shipment, and perform adverse experience surveillance and reporting.

Enrollment and Retention Monitoring and Support

We work with our clients to research and better understand the target patient population and will create a custom recruitment and retention program designed to overcome enrollment challenges. Our plans and services are tailored to programs of all sizes and customized to your needs.

Patient Retention

Our varied patient retention services are designed to motivate patients and maintain high study compliance, including

• Appropriate patient appreciation incentives at specific intervals to reiterate study importance and recognition of participation
• Call center utilization for follow-up to ensure study compliance and answer patient inquiries
• Visit reminder cards to alert patients of their upcoming study visits
• Communications, such as newsletters and disease-relevant education materials, to keep patients informed of the most current data available

Site Support

Our study managers provide site support services and technologies that allow the clinical site team to focus on study goals. During the active enrollment period, we deliver additional guidance and assistance, supporting sites by

• Maintaining a comprehensive knowledge of all studies and study-related materials
• Assisting sites with recruitment specific activities
• Answering study-related questions from sites
• Initiating or coordinating necessary follow-up