|
|
International Clinical Trials
|
Given that much of the world is
facing the challenge of a third wave
(France, Germany, Japan, Korea,
Spain) or even still the first wave
(India, the US), it requires a degree
of ‘blue-sky thinking’ to contemplate
what a post-COVID-19 world will
look like – even though the first
vaccines are now being widely
administered to populations outside
the clinical trial setting in several
countries (including the UK and the
US). As with any prediction, unless
one is either lucky, a gifted visionary,
or, indeed, both, the further into the
future one goes, the less accurate
the forecast is likely to be. With that
caveat, I would like to suggest a few
themes that I think it is reasonable
to expect will feature in this new,
post-pandemic landscape – which
I will place, a tad optimistically
perhaps, in the first half of 2022.
In order to reach this position, there
will have to be an effective vaccine
– or, rather more likely, several
effective vaccines – which will have
been administered to very many
people in most of the world. This is
likely to have a significant impact
on pharmacovigilance globally, both
in terms of the number of reports,
which will foreseeably arise from
the vaccine’s administration itself,
and because most, if not all, other
reports of (suspected) adverse drug
reactions will necessarily involve the
COVID-19 vaccine(s) as concomitant
medication(s).
|
Read full article from PDF >>
|
 |
 |
 |
Rate this article |
You must be a member of the site to make a vote. |
|
Average rating: |
0 |
| | | | |
|
|
Dr Thomas Leigh is the Head of the medical
group within patient safety solutions atCovance. He leads a global team of over
180 physicians and specialist nurses in key
locations across the US, Europe, and Asia,
that provide expert medical input as part of
a comprehensive safety offering to sponsors
around the world through their products’
entire lifecycles, encompassing clinical trial
and post-marketing/post-approval safety, for
drugs, devices, and combination products.
Before joining Covance in 2012 as a Safety
Physician, Tom worked for the MHRA, the UK
Regulatory Authority, as a Medical Assessor
and Unit Manager within the Vigilance & Risk
Management of Medicines Division (VRMM).
|
|
 |
 |
 |
|
 |
News and Press Releases |
 |
SPT Labtech acquires BioMicroLab
SPT Labtech, a global leader in the design and development of automated
instrumentation and consumables for life science applications, announces
the acquisition of BioMicroLab, a robotics automation provider for life
science laboratories.
More info >> |
|

 |
White Papers |
 |
Is Your Biobank Ready for the Challenge of Biomarker-based Research?
BioFortis
Targeted and personalized studies with well-defined patient segmentation biomarkers are becoming the norm in clinical trials. This increased interest in molecular biomarker studies necessitates a rigor and sophistication in sample management within the clinical trial context that is often not supported either by traditional clinical trial management software (CTMS), or biobanking systems. Download our Next Generation Biobanking whitepaper and learn about how to overcome the key challenges in clinical trial sample management from working in a distributed network of partners and stakeholder to managing consents and generating scientific insights.
More info >> |
|
 |
Industry Events |
 |
DIA Europe 2021
15-19 March 2021, VIRTUAL CONFERENCE
DIA Europe is the must-attend event for all life science professionals
working in drug development, from discovery to marketed use. It
encourages open collaboration by bringing together representatives from
the entire spectrum of the life science landscape and facilitating
crucial discussions across several topic tracks: Clinical Development,
Regulatory Strategy, Pharmacovigilance, Value and Access, Health Policy,
and many more.
More info >> |
|
|