Fast and Successful EDC Study Builds with Veeva Vault CDMS

By Janine Del Vecchio, Insmed Incorporated

You may think that late-stage changes to a study are the
exception and not the rule, but if you poll data managers,
you’d probably find that last minute requests are the norm.
You can almost anticipate you’ll face protocol changes
and/or CRF design changes and just have to manage.

During our first study build with Veeva’s EDC there was a
late-breaking shift in strategy. Our Phase II, early stage
feasibility study in a new indication turned into the
program-leading first trial. As we were finalizing the
database build, the MDs recommended that we establish
data collection standards for the new indication—starting
with this first study.

Success Highlights

“It was a total change in mindset and late in the game.
It would be a crunch to maintain existing timelines.”

INSMED – AT A GLANCE
Headquarters: Bridgewater Township, NJ
Year Founded: 1998
Employees: 400
Global Presence: 7 Countries
Ticker Symbol: INSM (Nasdaq)

Given the new challenge, we were thankful that
our Veeva team was so dedicated and responsive.
They never left our side and dug in deep to
immediately address each requested change.
In a time like this, it would have been easy to
panic and make silly mistakes. Instead, everyone
was executing beautifully.

The People, Processes, and Technology that Made it Possible

The onsite development of case report forms (CRFs) was particularly helpful. We got to see in real time, what the
proposed changes looked like. There was lots of back-and-forth between the Insmed functions, “Is this what we want?
No, could we make it look like this? Oh, well, on second thought… let’s make it this way.” All of that was implemented
right in front of our eyes, which was extremely helpful to making decisions and hitting our deadline. Veeva contributed
ideas and made recommendations during these discussions; their first-hand clinical experience and expertise designing
CRFs proved invaluable.

Veeva’s lead configuration specialist was a data manager herself, which was demonstrated by her sound advice.
Her input was highly regarded and sometimes a tie-breaker. Our objective was to develop CRF designs that would
make data collection user friendly and avoid confusion for our sites. Sub-optimal data collection designs can at times be
the outcome when EDC programmers work strictly from specifications, therefore having a team that understands data
management was really awesome and helped us achieve our objective.

Throughout the development process, we were in close communication with Veeva. Rather than use email which
would have been difficult to keep track of the entire picture, we kept a shared CRF change log. Our team used the
log to specify requests and Veeva used it to implement the updates or request clarifications and track completed work.
We also had direct access to Veeva’s development sandbox, so we could review and approve the updates as work
progressed. The shared view allowed both teams to move quickly and kept us in lockstep regarding what had been
implemented and what hadn’t.

Conclusion

Even with a change in approach affecting CRF designs, we still hit our deadline. Huge kudos go to the Veeva CDMS
team. If it weren’t for their dedication, we never would have made it. We’re so appreciative for Veeva’s commitment to
our success.

Overview: An Agile Design Process for Insmed’s Study with Veeva Vault CDMS