Clinical Trial Management

THE NOVUM ADVANTAGE SERVICES COMPANY NEWS CAREERS CONTACT LAMBDA PARTICIPATE IN A STUDY Services Best clinical data management company in PHASE II-IV CLINICAL TRIAL MANAGEMENT USA Scienti몭c Affairs Experience/Therapeutic areas Phase I Early Clinical Development Bioanalytical At Novum, the management of each clinical endpoint study is customized to each sponsor’s Phase II-IV Clinical Trial Management requirements. Data Management 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. Novum is experienced in a broad range of therapeutic areas and indications.   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 Serves as the single point of contact for the study sponsor site before inclusion in our network. Is chosen to lead a clinical endpoint study based on his or her speci몭c knowledge base Our detailed Site Selection Process includes: Lead the study team through each step of the process including Protocol design Determining eligibility via required quali몭cations of sites and Principal Selection of quali몭ed investigator sites Investigators Oversight of third-party vendors Reviewing Novum database to determine the best-quali몭ed sites for Coordination of statisticians, data managers, medical monitors, clinical study research associates and medical writers Engaging potential new sites and walking through the feasibility process Conducting background checks of all potential sites on FDA website, Complete involvement from the strategic planning stage through to the including review of audits, debarments, 483 issues production of the 몭nal report ensures… Reviewing insurance requirements and GDUFA registration for all sites Upon completion of a study, our Site Selection Department gathers feedback

Proper execution Upon completion of a study, our Site Selection Department gathers feedback The highest-quality deliverables from the investigator sites, assessments from Novum CRAs assigned to the Timely completion of each clinical endpoint study study and historical data regarding each site to determine future use of the site. Monitoring Quali몭ed investigator sites Our experienced Project Managers and our skilled Clinical Research Associates work together as a team to e몭ciently A network of more than 2,000 investigator sites in the USA, Puerto Rico manage site activity. and Latin American countries Background checks and inspections of each site’s recruitment Novum Monitoring Services include: capabilities, facilities and regulatory history Validation of each site’s experience to ensure it meets the requirements Conducting on-site Pre-Study Site Selection and Site Initiation review of the studies 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. Ready to get started? Find out how Novum can make the di몭erence on your next REQUEST A QUOTE clinical trial. 225 W. Station Square Drive Site by Suite 200 Pittsburgh, PA 15219 © 2023, Novum. All rights reserved. | PRIVACY POLICY