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 solutions.
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 management
- 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
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.