Clinical Trial Management

1. THE NOVUM ADVANTAGE SERVICES COMPANY NEWS CAREERS CONTACT LAMBDA PARTICIPATE IN A STUDY Services PHASE II-IV CLINICAL TRIAL MANAGEMENT Experience/Therapeutic areas Best clinical data management company in USA At Novum, the management of each clinical endpoint study is customized to each sponsor’s requirements. Scienti몭c Affairs Phase I Early Clinical Development Novum manages clinical endpoint studies that require large patient populations in multiple disease states, treated in an outpatient setting. 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. Bioanalytical Phase II-IV Clinical Trial Management Novum is experienced in a broad range of therapeutic areas and indications. Data Management   Novum is experienced in a broad range of therapeutic areas and indications. Project Management Site Identi몭cation Our Experienced Project Manager Team Site Identi몭cation utilizes a team of Novum specialists who conduct an extensive Site Selection Process of each investigator site before inclusion in our network. Serves as the single point of contact for the study sponsor Is chosen to lead a clinical endpoint study based on his or her speci몭c knowledge base Lead the study team through each step of the process including Protocol design Selection of quali몭ed investigator sites Oversight of third-party vendors Coordination of statisticians, data managers, medical monitors, clinical research associates and medical writers Our detailed Site Selection Process includes: Determining eligibility via required quali몭cations of sites and Principal Investigators Reviewing Novum database to determine the best-quali몭ed 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 Complete involvement from the strategic planning stage through to the production of the 몭nal report ensures… Upon completion of a study, our Site Selection Department gathers feedback

2. 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. Proper execution The highest-quality deliverables Timely completion of each clinical endpoint study Monitoring Quali몭ed investigator sites Our experienced Project Managers and our skilled Clinical Research Associates work together as a team to e몭ciently manage site activity. 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 Novum Monitoring Services include: Conducting on-site Pre-Study Site Selection and Site Initiation review Monitoring on-site Source-to-CRF veri몭cation Reviewing documents to ensure regulatory compliance Reviewing study drug for appropriate handling Resolving Data Queries Reporting 몭ndings 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 speci몭c needs of individual sites to ensure the successful completion of each study. Find out how Novum can make the di몭erence on your next clinical trial. Ready to get started? REQUEST A QUOTE 225 W. Station Square Drive Suite 200 Pittsburgh, PA 15219 Site by © 2023, Novum. All rights reserved. | PRIVACY POLICY