Project Management

Our Experienced Project Manager Team

• Serves as the single point of contact for the study sponsor
• Is chosen to lead a clinical endpoint study based on his or her specific knowledge base
• Lead the study team through each step of the process including
• Protocol design
• Selection of qualified investigator sites
• Oversight of third-party vendors
• Coordination of statisticians, data managers, medical monitors, clinical research associates and medical writers

Complete involvement from the strategic planning stage through to the production of the final report ensures…

• Proper execution
• The highest-quality deliverables
• Timely completion of each clinical endpoint study

Monitoring

Our experienced Project Managers and our skilled Clinical Research Associates work together as a team to efficiently manage site activity.

Novum Monitoring Services include:

• Conducting on-site Pre-Study Site Selection and Site Initiation review
• Monitoring on-site Source-to-CRF verification
• Reviewing documents to ensure regulatory compliance
• Reviewing study drug for appropriate handling
• Resolving Data Queries
• Reporting findings to the Project Manager
• Maintaining Trial Master File

Our team concept allows our Project Managers to manage a study from beginning to end and maintain real-time knowledge of the activities occurring at all sites throughout the clinical endpoint study, while allowing our CRAs to focus on the specific needs of individual sites to ensure the successful completion of each study.

Site Identification

Site Identification utilizes a team of Novum specialists who conduct an extensive Site Selection Process of each investigator site before inclusion in our network.

Our detailed Site Selection Process includes:

• Determining eligibility via required qualifications of sites and Principal Investigators
• Reviewing Novum database to determine the best-qualified sites for study
• Engaging potential new sites and walking through the feasibility process
• Conducting background checks of all potential sites on FDA website, including review of audits, debarments, 483 issues
• Reviewing insurance requirements and GDUFA registration for all sites

Upon completion of a study, our Site Selection Department gathers feedback from the investigator sites, assessments from Novum CRAs assigned to the study and historical data regarding each site to determine future use of the site.

Qualified investigator sites

• A network of more than 2,000 investigator sites in the USA, Puerto Rico and Latin American countries
• Background checks and inspections of each site’s recruitment capabilities, facilities and regulatory history
• Validation of each site’s experience to ensure it meets the requirements of the studies