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.

1. P H A S E II-IV C L I N I C A L T R I A L M A N A G E M E N T
Experience/Therapeutic areas
At Novum, the management of each clinical endpoint study is customized to each sponsor’s
requirements.
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.
Best clinical data m a n a g e men t company in
USA
Scienti몭 c Affairs
Phase I Early Clinical Development
Bioanalytical
Phase II-IV Clinical Trial Management
Data Management
N o v u m is
experienced in a
broad range of
therapeutic areas
an d indications.
Services
Site Identi몭 cation
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.
Our detailed Site Selection Process includes:
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 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
Complete involvement from the strategic planning stage through to the
production of the 몭n
a
l report ensures…
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
T H E N O V U M ADVANTAG E S E R V I C E S C O M P A N Y N E W S C A R E E R S CONTACT L A M B D A PARTI CI PATE IN A STUDY

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Monitoring
Our experienced Project Managers and our skilled Clinical
Research Associates work together as a team to e몭 ciently
manage site activity.
Novum Monitoring Services include:
Proper execution
The highest-quality deliverables
Timely completion of each clinical endpoint study
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.
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.
Quali몭 ed 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
Ready to get started?
Find out how Novum can make the di몭 erence on your next
clinical trial. R E Q U E S T A Q U O T E