The world of IT as we know it is quickly shifting from the client/server-based
“Second Platform” days to the “Third Platform” era, driven by the onslaught of
Big Data, mobile, social, and cloud technologies. We’re talking billions of
users, millions of applications, on millions of mobile devices.

While this shift represents opportunity in terms of growth and
innovation, it also brings new challenges and risk. Companies now not only have
to manage huge amounts of data, but they also have to protect and optimize it,
and make sure the right information is accessible to the right users at the
right time. If they fail at this, the entire business is at risk. On the other
hand, if it’s done right, it’s a game-changer.

So, how do you do it? And if you’re thinking about moving to the cloud,
how do you make your journey successful? Transformation starts where work
happens — at the intersection of content, process, and collaboration. But the
real enabler lies in connecting information to work through the power of

What’s missing today

For every new technology disrupting the workforce, there are just as
many — if not more —  “next-generation” content management vendors adding to the
confusion and noise. These vendors are focused on providing point products to
help companies manage their front and back office processes. But they’re
missing the bigger, more important piece of the puzzle: the need for third platform-enabled,
enterprise-grade cloud solutions aimed at the Value Office.

High value, industry-specific solutions

What do I mean by Value Office? It’s the core and lifeblood of every
business — the set of work and employees chartered solely with creating value for
the organization, creating real solutions to help solve their customers’
toughest business problems.

But there’s even more opportunity to be had here with the cloud. By leveraging
cloud technologies, businesses can extend and enrich their existing Value
Office capabilities. And that has far-reaching implications, especially when
you consider the transformative effect cloud can have on industries like healthcare,
life sciences, energy, and engineering.

Take big pharmaceutical companies, for example, which have an extremely
long and costly product development lifecycle. A key factor in completing the
development process is the rapid and efficient conduct of clinical trials. The
speed of a trial can be improved by tracking what documents have been received
and which are still outstanding, along with who needs to supply them.
Subsequent stages of the trial cannot proceed without complete collection of
required files in a prior stage.

Using cloud-based Enterprise Content Management (ECM) solutions, pharmaceutical
companies can collaborate easier on research and development activities with
external partners and subsequently reduce clinical trial durations to get to
the market faster. This is significant because revenue cannot begin until the
drug has been approved for sale. The development period is approximately 12
years plus another year for review by the agency, leaving around seven years of
protected sales under the patent. And every extra day a drug is on the market
within an active patent window can generate up to $3M* in additional revenue. By
the same token, every extra day it takes getting a drug on the market increases
the odds that a competing drug will make it to market beforehand, which can
mean the loss of millions in potential revenue.

When beginning a trial, the trial manager uses an ECM solution to plan
the documents and the quantity of each document type expected. As documents come in, they are tracked
against the plan and status reports can be generated showing what is missing
from the plan and who is responsible to provide them.  As an example, during the first stage, which
is Study Startup, the stage cannot be closed out and progress the trial into
the Site Initiation stage until the approval is received from the IRB/IEC
(independent review board). The sponsor
cannot recruit investigators and negotiate contracts until this approval has
been received. Often trials will sit in
an incomplete state not able to move forward to the next stage because of
inadequate tracking of critical documents. 

By tightening the timeline to conduct a trial, it’s reasonable to
assume that you can reduce several weeks from the historical average. The actual time to conduct the trial is
dependent on numerous factors such as type of trial, number of sites and
patients, number and frequency of visits with a patient, etc.  Numerous trials are conducted within the
process of development to bring a drug to market, anywhere from 10s to 100s although
some trials may be conducted in parallel. If 1-2 weeks can be saved per trial,
the overall shortening of development may add up to 2-3 months. Using a conservative revenue estimate of
$1M/day for a drug at the end of patent, that would exceed $60M.

Time to bring a new drug to market also impacts the drug’s supremacy in
the market. If there are several
sponsors competing to bring their new compounds to market, reducing the timeline
can be the difference between being 1st, 2nd or last to
market. Placement in the “1st
to market” race can have enormous impact on eventual revenues. Being 2nd or 3rd to
market can reduce the total revenues by significant factors based on physician
and public impressions.

ECM solutions help address this need for speed as well as meet the
stringent regulatory requirements these organizations face. Here are just
some of the critical capabilities needed in a configurable, purpose-built
solution to provide these expected benefits:

  • Accurate trial planning
  • Faster clinical trial setup and approval to
    enter the next stage of a trial

  • Reduced complexity and risk in trial document

  • Improved productivity of clinical trial workers
    across the drug development lifecycle process

  • Regulatory compliance through extensive audit
    trails, access control, lifecycle management, and version control of clinical
    documents and records

  • Persistent inspection-readiness

Enabling Transformation

Naturally, the stakes are high. And creating these
industry-transforming solutions requires deep domain expertise and a
fundamental understanding of an industry’s value chain. While customers in specific
industries have domain knowledge, they might lack the necessary infrastructure,
content management expertise, and resources to develop these solutions
in-house. They may not have a clear path to the cloud or the capabilities they
need to get there.

As the IT leader in your company, you need to carefully evaluate and
select an ECM vendor that brings the following things to the table:

  • Enterprise-grade ECM
  • Industry knowledge

  • Best practices

  • A broad partner ecosystem

  • A flexible deployment model that provides just
    “as much cloud as you need” based on where your company is in its evolution

And all of this should be backed by a company with a proven history of
trust in infrastructure and cloud deployment. It’s not an either/or scenario,
but the combination of these things
that will drive real business benefits. And what company does not want to
increase its productivity, ensure compliance, fuel innovation, lower costs, and
speed time to value?

By Rick Devenuti, President,
Information Intelligence Group, EMC.