Project Management

Our experienced Project Managers serve as the single point of contact for the study sponsor. Each has therapeutic expertise and is chosen to lead a clinical endpoint study based on his or her specific knowledge base. They lead the study team through each step of the process, from protocol design, selection of qualified investigator sites and oversight of third-party vendors to coordination of statisticians, data managers, medical monitors, clinical research associates and medical writers. The involvement of the Project Manager from the strategic planning stage through to the production of the final report ensures proper execution, the highest-quality deliverables and 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. In addition, sponsors may contract our monitoring services for Early Phase studies conducted in our clinics.

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

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 Latin American countries.

Trained Clinical Research Associates

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
  • Pharmacology
  • Anatomy and Physiology
  • Statistics
  • 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, 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.

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Find out how Novum can make the difference on your next clinical trial.