Clinical Trial Management
At Novum, we approach the management of each clinical endpoint study and the delivery of our services as unique and customized to each sponsor's requirements.
Novum understands that the medical and commercial success of your new product relies on the ability of the CRO to safely and efficiently collect and analyze study data and prepare comprehensive reports.
Novum manages clinical endpoint studies that require large patient populations in common disease states treated in an outpatient setting. These studies, frequently involving thousands of patients, have resulted in 20 ANDA and NDA approvals since 2001. With a nationwide network of more than 2,000 investigator sites, we ensure that all selected sites meet the requirements of each study and Novum's high standards.
Novum is experienced in a broad range of therapeutic areas and indications.
Novum conducts background checks and inspects each site's recruitment capabilities, facilities and regulatory history, and validates its experience to ensure that each site meets the requirements of the studies we manage. We currently have a network of more than 2,000 investigator sites in the USA, Puerto Rico and Central America.
The Novum Clinical Research Associates (CRA) Academy trains clinical research associates in our Clinical Trial Management division. This innovative program provides extensive classroom and on-site training for new CRAs who must first pass a rigorous selection process.
The classroom training provides a solid foundation in research practices, conducting site visits and regulations governing research. CRA Academy training includes:
- Good Clinical Practices
- Conducting Site Visits (Inspections, Initiations, Monitoring and Closeout)
- Adverse Event/Serious Adverse Event Monitoring and Reporting
- Research Ethics
- Anatomy and Physiology
- Data Management
Upon successful completion of the classroom training, CRAs advance to supervised fieldwork under the direction of senior CRAs and Project Managers.
Completing this program equips Novum CRAs with the skills and abilities required to monitor sites, maintain participant safety and ensure the integrity of data for their assigned studies.
Training and mentoring in job-specific competencies, as well as in overall career development, continues for CRAs. Novum also offers a training program for experienced CRAs who monitor Early Phase studies. The program provides detailed instruction from experienced trainers in a classroom setting, training in the field, and extensive testing and performance-based evaluation.