Effective project and site management is essential to the successful completion of your study. With a staff of project managers, clinical trial coordinators (CTCs) and medical research associates (MRAs) (monitors), the Clinical Operations Group assures that your studies are managed by experienced clinical research professionals situated in our New Jersey headquarters, as well as in strategic locations throughout the United States.
These professionals work closely with investigators and their coordinators, focusing on regulatory documentation, adherence to protocol guidelines and accurate data collection and recording. We build relationships with investigators and their staffs, facilitating recruitment and communications. We also maintain an extensive database of these investigators with whom we have worked in many therapeutic areas.
The Clinical Operations Group embraces technology and uses an advanced, Web-based query resolution system, to provide you with significant time and cost savings on site monitoring. With our Web-based project management system, our project managers have immediate access to all logistical aspects of a trial, enabling real-time status reporting to you.
Clinical Operations
| · Protocol writing |
· Central laboratory |
| · Investigator recruiting and contracting |
· Central pharmacy |
| · Site qualification |
· Investigator meeting management |
| · Regulatory documentation |
· Drug packaging |
| · IRB approvals |
· Financial management |
| · Study kit development and production |
· Project management |
| · Clinical monitoring |
· Site management |
| · Medical monitoring |
· ADE/SAE reporting |
| · CRF development, design and production |
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