Home' Australasian BioTechnology : Vol 26 No 3 Contents Australasian BioTechnology | Volume 26 | Number 3
Australasian BioTechnology | Volume 26 | Number 3
Every day, clinical trials advance our
understanding of how disease affects the human
body and how medicines, medical devices and
diagnostic tools relieve suffering and save lives.
Thanks to advancements in technology, results
of this research are more readily available than
ever before, decreasing product-development
time and enabling therapeutic products to reach
the market sooner.
In an era where high-integrity information is vital,
research companies are under increasing pressure
to deliver cost-effective clinical trial results and
development programs. Moreover, they need to
adhere to ever-changing regulations while delivering a
healthy return on investment.
Since 2008, Australian-owned and -operated Mobius
Medical has built a solid foundation, delivering the
traditional services of a contract research organisation;
offering study design, biostatistics, clinical trial
management and data-management services.
One of the many things that sets Mobius apart from
its competitors is flexibility, especially in its innovative
approach to quoting and billing. At Mobius, all possible
tasks and costs are identified up-front with our clients,
and our responsibilities are identified and costed. This
means that many clinical trials come in on, or under, the
estimated budget. It’s on this client-centric foundation
that Mobius has evolved, with the combination of
clinical research experience and technology tools to
improve efficiency, reduce costs and improve the
quality of clinical trials.
Some other key tools that have been implemented include:
customised electronic data capture (EDC) build and
electronic patient-reported outcomes (ePro)
real-time data reporting for safety monitoring
interactive online training.
Mobius Medical has developed software validation
and verification processes, allowing the customisation
of clinical trial software and systems integration,
and ensuring its compliance to Food and Drug
Administration (FDA), European Medicines Agency (EMA)
and International Conference on Harmonisation,Good
Clinical Practice (ICH-GCP) requirements. In-house
technical expertise and a certified verification process
ensure that the most cost-effective tools are implemented,
enabling clinical trials to be conducted with all the
real-time data visibility and reporting required by our
clients. Software such as OpenClinica is paired with
ePRO, allowing patients to complete questionnaire data
on a tablet, which is then imported into the database. As
many or as few validation checks can be programmed as
required. In addition, laboratory pathology test results
are integrated quickly, along with imaging and other
de-identified source reports, directly into the EDC.
Mobius is also excited to have entered the world of the
smart phone app through partnership with the clinical trial
referral app nRoll (www.nrollclinical.com). In the clinical
trials arena, apps provide many advantages. The prevalent
use of smart phones ensures that apps reach vast numbers
of people, which enhances clinical trial recruitment.
They also provide succinct information to potential
participants and relevant health professionals, which
provides the advantage of casting widespread, secure and
accurate information about a trial. Apps are used during
participation in a clinical trial to set visit reminders, check
compliance and log measurements. Mobius is excited
to be using nRoll for many of its studies, as it is quickly
and easily customisable to a protocol, language sets and
geographical contact hubs.
It’s an exciting time to be part of biotech. In the
ever-changing world of clinical trials and digital solutions,
Mobius Medical is proud to partner with its clients to
offer highly innovative, yet cost-effective solutions using
their extensive clinical and technical knowledge.
THE NEW ERA OF CLINICAL
Principals, Mobius Medical:
Stefan Czyniewski, Richard Brookes, Suzanne Williams
501002E_Mobius I 2287.indd 1
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