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Powerful
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Comprehensive
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Easy to Use
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Flexible
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Customizable
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Quick to Implement
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Glossary of Clinical Trial Management Terminology
1572
FDA form that must be completed by every doctor participating in a clinical trial.
See - US Food and Drug Administration.
21 CFR 11
aka "21 CFR Part 11" is a US governmental regulation with requirements
for electronic tools that create/track electronic records and/or that use electronic
signatures: this regulation requires that software used in clinical trials has an
audit trail, password controls, etc. and is developed in a manner that shows that
quality controls have been applied during the software development process. TrialWorks
is 21 CFR 11 compliant.
Biotech research
TrialWorks is
the perfect tool for managing biotechnology trials and is used by top Biotech research
organisations such as
Gilead Sciences,
OSI Pharmaceuticals,
Family Health International,
and Eyetech Pharmaceuticals
among many other research organisations.
Clinical Research Associate
A Clinical Research Associate, also known as a Monitor, is an individual that oversees
the progress and conduct of a clinical trial.
A clinical trial is usually implemented by physicians at a hospital, clinic, or
physician's office. The CRA is required to oversee the initiation, progress, and conduct
of the clinical trial to ensure the scientific integrity of the data collected, and the
protection of the rights, safety, and well-being of human study subjects.
Clinical trial
A clinical trial is structured research to answer specific questions about new drugs and
therapies. Clinical trials are conducted to determine the effectiveness and safety of new
drugs or treatments, or to find new applications for existing drugs.
Clinical Trial Management Software
Also called a Clinical Trial Management System is specialized software that tracks all
information pertinent to a clinical trial allowing closer management, time savings and
standardized reporting. TrialWorks
is a fully featured CMTS favoured by top level pharmaceutical companies, biotech companies,
CROs, and specialized research organizations all over the world.
Contract Research Organisation
A specialist company that conducts some or all of a clinical trial on behalf of a sponsor
organisation. A CRO assumes, as an independent contractor with the sponsor, one or more of
the obligations of a sponsor, e.g.., design of a protocol, selection or monitoring of investigations,
evaluation of reports, and preparation of materials.
clinicaltrials.gov
AUS website where sponsors can post details of clinical trials that they are conducting;
required for serious and life-threatening diseases, optional otherwise.
CRA
See Clinical Research Associate.
Case Report Form
Commonly reffered to as a CRF, case report forms are where the actual medical data for a
patient participating in a clinical trial is logged.
CRO
See Clinical Research Organisation
CTMS
See Clinical Trial Management Software
Data Migration
We can migrate your legacy data, in virtually any format, directly into
TrialWorks
Data Integration
TrialWorks offers both realtime,
two-way data exchanges and one-way data exchange (into TrialWorks),
depending on the nature of the data source. TrialWorks
is CDISC compliant.
EDC
See Electronic Data Capture
Electronic Data Capture
Capturing patient medical data electronically, rather than on paper saves time and
increases accuracy of trial data.
FDA
See US Food and Drug Administration
Interactive Voice Recognition
Interactive Web Response (sometimes referred to as IVR, IWR, IVRS, and IWRS) is technology
used for patient enrolment, randomization, and medication management.
TrialWorks is able to be used with
voice recognition software simplifying data entry and reducing interview and data entry time.
Institutional Review Board
An IRB is an independent committee of physicians, statisticians, community advocates,
and others that ensures that a clinical trial is ethical and the rights of study participants
are protected. All institutions that conduct or support biomedical research involving people
must, by federal regulation, have an IRB that initially approves and periodically reviews
the research
IVR
See Interactive Voice Recognition
Pharmaceutical Research
TrialWorks is the perfect tool for
managing the clinical research and testing of new pharmaceutical products and is used by
top research organisations such as
Gilead Sciences,
OSI Pharmaceuticals,
Family Health International,
and Eyetech Pharmaceuticals
among many other research organisations.
TrialWorks
Full featured Clinical Trial Management Software. Part of ClinPhone's integrated suite
of medical and research software products.
US Food and Drug Administration
Aka the FDA, is the US governmental body that reviews and approves the release of new
drugs and treatments in the United States. The FDA has strict guidelines for clinical
testing and trials must adhere to a strict set of standards and redulatory proceedures.
TrialWorks is
an ideal tool to ensure correctly formatted, validatable data is presented.
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