Straight Talk Special Issue: Life Sciences & Healthcare - 21

We've also added an e-signature process to
support regulatory compliance. Once the report
is approved, the system automatically sends it to
an electronic trial master file system, which
keeps the document management system intact
without needing human intervention.
Another critical path task that technology has
changed is site assessment. In the past, we had
to visit every site at the beginning of a study, and
every six to eight weeks thereafter. Now we have
an option to apply a risk-based monitoring, or
RBM, approach. with a system to evaluate how
each specific clinic is performing and how it
handles its subjects' data. RBM studies are
designed to enable the monitoring system to
analyze site information to determine how often
a particular site actually needs to be visited. The
system then imports the data back into CTMS
for documentation. RBM focuses on monitoring
where it will be most effective, safeguards
patients, and makes study management more
efficient and cost effective.

The challenges of digital disruption

Documentation is everything in this industry. A
regulator or pharma company can show up and
request an audit at any time, so we have to
document everything - with names and time
stamps to show who requested something, who
approved it, when it was done, and that it was
verified. And we have to be able to provide that
documentation on a moment's notice. Including
that level of compliance in your systems makes it
hard to implement new features quickly.

Transformation starts with understanding and
sharing the need for change, with regression
information to show how adding new features
will affect current processes. You also need to
discuss who will implement the changes and
how they will affect current processes. You have
to make sure the business has documented its
processes correctly and that the IT team is
prepared to support the new process being
implemented.
Covance has established a change control
review board that meets once a month. One
representative from each department presents
suggestions for enhancing the CTMS. The
leaders then work with the IT team to determine
which suggestions can be implemented and in
what order until we have enough to release an
upgrade. There are lots of factors that affect
what we do and when, but we vet every single
suggestion, and it helps people feel a sense of
ownership around changes.
There is much work to do before new
technologies can be optimized for research,
because the industry is still assessing them. For
clinical trials, we want to streamline processes as
much as possible while keeping quality at the
highest possible level. If we lose the trust of the
pharma, biotech or medical device companies
or patients, all is lost.

For clinical trials, we want to streamline processes as much as
possible while keeping quality at the highest possible level.

21
Straight Talk Special Issue: Life Sciences & Healthcare

Table of Contents for the Digital Edition of Straight Talk Special Issue: Life Sciences & Healthcare
