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International Clinical Trials
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ICT: Can you tell us more about your recent partnership with ARISGlobal?
Anne Zielinski:
Pharmacovigilance as a service, which enables sponsors to reliably
outsource safety reporting, is a rapidly growing area for Bioclinica.
Under this partnership, we have named ARISg from ArisGlobal as our
preferred safety platform, and ArisGlobal has chosen Bioclinica as its
preferred vendor for implementation and business processes consulting.
How is this initiative contributing to the eClinical environment?
We
are increasingly seeing clinical trial sponsors express a preference
for enabling technologies within an integrated platform as a service
model. Our collaboration with ArisGlobal responds to this shift by
bringing an end-to-end platform solution to the industry that minimises
sponsors’ concerns as to which technologies are being used and how they
are connected. The integrated Bioclinica Express electronic data capture
(EDC) and ARISg offer many advantages for sponsors, including optimised
processing of adverse events.
And how, in particular, is ARISGlobal’s Safety Cloud enhancing Bioclinica’s pharmacovigilance services?
Traditionally,
sponsors have licensed safety systems and hosted them in their own
premises − a model known as ‘on premise’. It requires sponsors to assume
all responsibility for hosting and maintaining hardware, implementing
upgrades and applying software patches. By comparison, ArisGlobal’s
Safety Cloud allows sponsors to outsource these functions, while
simultaneously achieving high availability and up-to-date regulatory
compliance. Bioclinica’s safety case reporting leverages ArisGlobal
Safety Cloud features.
What are the current challenges of pharmacovigilance and the eClinical landscape respectively?
Getting
all clinical research systems to work together so that the end user has
the experience of using a single system is a major challenge. Another
hurdle is how to leverage the richness of the data that comes with
predictive analytics and machine learning to extract insights for
improved quality in the overall research process.
Bearing in mind the benefits of eClinical solutions, are there any disadvantages/issues that need to be considered?
Innovative
eClinical solutions hold promise to yield even greater value than they
do now, but sponsors’ concern over regulatory acceptance can impede
adoption. Our industry will greatly benefit from sponsors and regulators
working more closely to explore and implement the full capability of
technologies. At the end of the day, it is about a shared goal to
improve research efficiency and productivity, while protecting patients
at the same time.
What is next in the pipeline?
More
robust and predictive analytics incorporated in smart ways in the
planning and conduct of trials; leveraging mobility to reduce subject
time at the site and to enhance data comprehensiveness; and increased
fluidity and ease in the user experience.
What do you think clinical trials will look like in 10 years’ time?
While
clinical research will continue to be carried out rigorously, the
apparent differences between clinical research and routine care will
become blurred. Smaller and smaller cohorts will be analysed as more
data – genotypic, phenotypic and behavioural – allow for greater
population segmentation.
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