Pharmaceutical Product Development
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Services: Clinical Monitoring & Management
The best way to avoid expensive problems with your clinical development program is to use experienced clinical trial monitoring teams. We spare no effort in creating teams with strong healthcare backgrounds who participate in ongoing, formal training. Most senior monitors have earned CCRA accreditation, possess many years of experience, and are dedicated to building relationships with investigators and study coordinators. Many are ISO 9000 certified. Our clinical trial monitors have a command of the issues most important to you, promoting positive two-way communication, which reduces the potential for failure during the regulatory process.
Cato Research recognizes the need for educational programs to prepare and update clinical trial monitors in all aspects of their work. The company offers the Portable Desktops Clinical Monitoring Series™ to provide interactive, computer-based GCP Training for clinical trial monitors. In addition, the Adverse Event Reporting Module provides interactive, computer-based training for reporting adverse events.
Our team of medical and scientific professionals is able to identify potential investigators and maintains a database of investigational sites. We also provide effective strategies for rapid patient recruitment. We can design, manage, and conduct comprehensive investigator meetings for multiple-site studies. We have highly proficient monitoring staff experienced in conducting site evaluation visits, site initiation visits, periodic monitoring visits, and study termination visits as well as all in-house monitoring functions, including adverse events reporting, and clinical trial material management.
Our monitors are all well acquainted with the needs of our clinical data management group, enhancing the efficacy of the entire process. All clinical monitoring activities are performed according to established ICH guidelines to ensure compliance with cGCPs.
Cato Research designs, manages, and conducts Phase 1 through Phase 4 clinical studies, ever mindful that quality, time, and cost are critical to sponsors. Our approach focuses on effective, mutual communication, partnership, and flexibility in developing strategies with your specific needs in mind. We recognize that one clinical study approach does not fit all. Our experienced project teams not only create individualized strategies, but also support this work with advanced protocol and case report form development to keep the project on track. We can completely manage your clinical development program or integrate with your staff as a true extension of your company. By partnering with Cato Research, you can ensure that your clinical trial gets the attention it deserves.