Ahead of the marcus evans Evolution Summits 2016 & 2017, read here an interview with Graeme Ladds discussing drug safety data best practices

1. How to Get Your Drug Safety Data
Ready for Phase III
Interview with: G r a e m e L a d d s ,
Chief Executive Officer, PharSafer®
“In clinical trials, there is normally
very little safety data in phase I and
phase II, therefore most companies do
not think about centralizing data into
one database or fully analyzing it,” says
Graeme Ladds, Chief Executive Officer,
PharSafer®. However, getting the
details corrected in phase III when they
are already working in 15 sites in 15
countries can lead to costly delays, he
explains.
PharSafer® is a specialist contract
research organization (CRO) at the
marcus evans Evolution Summit Fall
2016 and the Evolution Summit
Spring 2017 in North America.
What is troubling Chief Medical
Officers (CMOs) today?
Getting consistency across the various
geographic regions and the different
CROs they use. In a clinical program, it
is not unusual to have five CROs
involved in various stages, but data
must be captured and coded in the
same way. One CRO should be in charge
of safety, making sure all the
information matches in one central
database, so that identifying potential
safety signals can be handled quickly
and fully.
Otherwise, patient safety can be
compromised and there may be delays
in submitting information to the
regulatory authorities or when applying
for a new license.
What should the safety reporting
plan include?
The plan for safety is multi-layered. The
Sponsor needs a plan to make sure they
know where reports have to go, when,
who they need to go to and in what
format. When multiple sites are
involved, this will ensure information is
submitted on time, is compliant and
accurate for all of the regulatory
agencies.
Many clients are surprised when we
mention this, because they never
considered it in the past, but it makes
perfect sense to them. With our
solution, every time a regulatory agency
around the world changes a rule, they
will know. Most companies rely on a
database to be able to do this, but a
database cannot keep them current and
compliant on all rules that impacts their
company’s clinical program(s).
At which point should they focus on
this?
In the ideal world, pharma companies
would come to us before phase III, to
make sure they get things done right
the first time, including the Case Record
Forms (CRFs) and the data is easy to
use and ready for phase III. They
usually do not, and we find that the
data we inherit from phase I and II has
to be amended or the electronic case
record forms are not ideal. Some
companies ask to carry on even though
it would be inefficient to do so.
How can safety and efficiency
during clinical research be
enhanced?
The design of the case record form,
making it easy for investigators to
understand not only how to complete it
but where it goes. If it is an electronic
form, the data fields should match with
the safety database to enable direct
imports from the clinical to the safety
database. If investigators are not
trained properly, many queries will be
raised, which will slow down adverse
event reporting and the closing of cases.
What trends should CMOs prepare
their organizations for?
In a clinical trial program, there are a
number of requirements now, not only
for the reporting of adverse events but
also for the license submission. What
companies are not completely
appreciating is actually think how an
individual case safety report can impact
the other regulatory documents they
have to produce.
For example, if a certain adverse
reaction has been caused by the
product, they need to include it in and
have already set up the developmental
core safety information. As well as
reporting it to regulators, it should be in
the document ready for license
submission. Equally, if it is a serious
adverse reaction they think might
impact the patient population, it should
be in the developmental risk
management plan, another document
that has to be ready for license
submission. When they are preparing all
these documents in parallel, if all the
data is in place ready for submission, it
will save them lots of time.
A database
cannot keep
them current
and compliant
on all rules
that impacts
their company’s
clinical
program(s)

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About PharSafer®
PharSafer® is a specialist Global CRO focusing on Pharmacovigilance & Medical Services. Formed in 2002 and Headquartered in the
UK, PharSafer® has enjoyed continued annual client growth, global expansion and increased staffing. As a privately owned
company we have the freedom to invest in our staff and react quickly to investment in any necessary equipment, premises and
additional resources, without reference or approval of any external investors. This allows us to prudently invest where necessary to
ensure clients get the best people to help them, and the most up to date technical equipment.
We can act as your complete outsourced Pharmacovigilance and Medical Services Department / Organisation, performing all of the
activities expected of your own Pharmacovigilance and Medical Information teams. We ensure that your company is compliant with
all of the necessary legislation and our Philosophy is simple; Quality and Excellence in all we do because patient safety is not a
cost, but a commitment.
www.pharsafer.com
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To view the web version of this interview, please click here:
http://events.marcusevans-events.com/evolution2016/2017-graeme-ladds