Clinical Trial Management

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PHASE II-IV CLINICAL TRIAL MANAGEMENT Experience/T
herapeutic areas At Novum, the management of each
clinical endpoint study is customized to each
sponsors requirements.
Best clinical data management company in USA
Scienti??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
Novums high standards. Novum is experienced in
a broad range of therapeutic areas and
indications.
Bioanalytical
Phase II-IV Clinical Trial Management
Data Management
Novum is experienced in a broad range of
therapeutic areas and indications.
Site Identi??cation Site Identi??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
speci??c knowledge base Lead the study team
through each step of the process including
Protocol design Selection of quali??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 ??nal report
ensures
Determining eligibility via required
quali??cations of sites and Principal
Investigators Reviewing Novum database to
determine the best-quali??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
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Proper execution The highest-quality
deliverables Timely completion of each clinical
endpoint 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. Quali??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 sites recruitment
capabilities, facilities and regulatory
history Validation of each sites experience to
ensure it meets the requirements of the studies
Monitoring Our experienced Project Managers and
our skilled Clinical Research Associates work
together as a team to e??ciently manage site
activity. Novum Monitoring Services include
Conducting on-site Pre-Study Site Selection and
Site Initiation review Monitoring on-site
Source-to-CRF veri??cation Reviewing documents to
ensure regulatory compliance Reviewing study drug
for appropriate handling Resolving Data
Queries Reporting ??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 speci??c
needs of individual sites to ensure the
successful completion of each study.
Find out how Novum can make the di??erence on
your next clinical trial.
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