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Our data management team has a
breadth and depth of experience with clinical resarch,
spanning more than 40 years and across all phases and a
wide variety of indications.
Collectively, our team has
successfully managed and implemented research projects
within academia, CROs and industry (Pharma).
Our experience enables us to
provide customized data and project management and
support for a variety of research endeavors.
Proposal Development
Sound
statistical components and rigorous attention to
regulatory concerns are keys to a strong proposal. With
more than 40 years of combined experience in human
studies research, the DTCC staff has both the expertise
and experience to provide support in these areas.
Review topics may include hypothesis development,
statistical feasibility and design, outcomes
measurements, regulatory compliance (FDA, HIPAA, GCP,
etc.), operation and data management plans, logistical
considerations and analysis plans.
Protocol Development
Protocol development is a process that requires repeated
reviews, varying experience, and overall organization to
maintain version and document control.
We work in collaboration with the study
investigators, statisticians, and other key personnel to
help investigators prepare detailed study protocols.
We pay attention to overall consistency,
adherence to regulatory requirements, and precise
wording so investigators can focus on overall content
and study design.
We coordinate organizing, editing, and
distribution of
various drafts to the appropriate parties, while
maintaining version control. Once final, we post the
finalized version to our study-specific portal workspace
for easy access by authorized team members.
Project Management
One
of the critical yet time consuming efforts related to
research is managing the overall project. Making sure
timelines are developed and adhered to, milestones are
met, and reporting is consistent and accurate are just a
few of the responsibilities of the Clinical Data
Management team during the management of a study.
We work with the sites, investigators,
biostatisticians, third party vendors, and regulatory
agencies to schedule and facilitate meetings, develop
overall implementation plans with related
documentation, and ongoing reporting for the
studies.
Data Management
Making sure data is captured, clean, and reported
accurately and efficiently is the highest priority for
the RTRN DTCC. Our data management team has vast
experience with clinical research, spanning more than 40
years and across all phases as well as a wide variety of
indications. We have collective experience with all aspects of
clinical research, from data entry through project and
data management, clinical oversight, quality control and
monitoring, site and data auditing (internal, external,
and FDA), as well as from an investigator’s perspective. Our team has extensive experience with research
from within academia, clinical research organizations
(CROs), and industry (Pharma).
This wealth of experience ensures effectiveness
as well as a high-level of insight when providing
support for the investigators.
Electronic and Remote Data Capture
Our
databases are collected and stored using Oracle Clinical
Remote Data Capture System (OCRDC).
Advantages to using this system for electronic
data capture include: 1) the ability to create data
collection forms once and the ability to reuse them over
and over for other studies establishing a global library
of case report forms; 2) real-time generation of
discrepancies at the sites, and 3) online, 24-hour
secure access to the database and standard operating
tools. The
OCRDC system and database are 21 CFR Part 11 compliant,
and enable streamlined adoption of standards, such as
the CDISC SDTM.
The DTCC’ is also able to support your
non-regulated studies, through a variety of solutions.
Tool and application selection depend on the
study-specific and investigator’s needs.
Coding
Our
Coding of adverse events and concomitant medications
within the Oracle Clinical (OC) system is conducted
through an automation first schema: The Oracle Thesaurus
Management System (TMS) auto-encodes as many terms as
possible; and, for terms that do not automatically code,
the study Data Manager
manually codes the terms that will be remembered
by the system for future use.
The WHODrug and MedDRA coding dictionaries are
being used, however, the system also allows
sponsor-specific coding dictionaries to be used.
Study Training and Coordination
We
work with the study investigators in various capacities.
The DTCC offers assistance in the training of
site team members as well as supports the investigators
in the development of the manual of
procedures (MOP).
We offer assistance in reviewing and editing of
the MOP to ensure proper understanding of study details
which results in having a study team that is more
comfortable during training and capable of successfully
implementing the activities outlined in the manual.
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