When we talk to our clients and colleagues in the pharmaceutical industry, their stories are very consistent: They are overwhelmed by the amount of information and documentation required to research, develop, approve, launch and commercialize a drug.

As one executive said, “If you think about it, we really produce two products: the marketed drug—and all of the documentation needed to support it through its lifecycle. And somehow, somewhere along the way, it becomes an information vortex.”

How did we get here?

The demand for information and documentation has grown exponentially as regulatory and compliance requirements have increased in scope and complexity. Patients, payers, and administrators are also playing a greater role in treatment and prescribing decisions, and desire increasing amounts of product information to inform those decisions. Throughout the research, development and commercialization processes, companies must capture, create, review, manage, store, distribute and track critical content and documentation.

Getting it wrong can impact approval, successful commercialization and create compliance risk for the company as a whole.

Are you trapped in an information vortex?

In a typical “information vortex,” there are many people creating, reviewing and approving information and content, using multiple tools and systems, stored in many places, shared over email or other platforms. The relative lack of process and structure leads to low reliability and confidence in the information. Knowledge workers can lose significant time searching for, retrieving and creating content, and tracking it through the collaboration, review and approval process.

When was the last time you had this conversation: “Is this the latest version of the document? Does it include the most recent results? Where is the citation for this? Has it been reviewed by Legal and Marketing?” That’s the information vortex.

But it doesn’t have to be this way.

Your information management strategy, explained

An integrated, enterprise strategy will help you define the processes and select the tools to manage regulated information and documentation across the lifecycle of the products in your pipeline from research and development to commercialization and medical information. It will drive consistency, transparency and compliance, answering a number of questions.
• What systems and tools are best suited for managing our regulated and controlled content?
• How can we make our creation and review and distribution processes more efficient?
• How do we enhance quality control and compliance?
• How can we reuse content and information around the globe and across business functions?

Ultimately, an information management strategy will drive significant competitive advantage in terms of costs, time and the quality of your information—and create a more positive experience for your colleagues, partners and patients.

If you would like to continue the conversation or learn more about the benefits of our approaches to developing an integrated information management strategy, email Mark Lane or Bruce Lotier.

The fact is that most companies still view IT and the CIO role through the narrow lens of providing technology-based services; they have not broadened that view to take into account the stunning changes wrought by digital technology. IT is no longer simply responsible for building, operating, and maintaining infrastructure; it’s responsible for data governance, driving growth through data analytics, cyber security, connectivity and integration. However, since most organizations are peering through the old lens of IT-as-service-provider, they are blind to IT as a revenue-producer. The irony here is that Sales, Marketing, R&D, Finance, and HR—those typically considered revenue-producing—are only able to do what they do because of IT and IT’s ability to stay ahead of the curve.

According to a recent IBM study of 4,100 C-suite executives, only 42% of CIOs were involved in strategy, as opposed to 72% for CFOs and 63% for CMOs. This is puzzling. Since IT touches everything, the CIO has an enterprise-wide vision that would be invaluable in integrating an enterprise-wide strategy. Luckily, the IBM study suggests that this is turning around—the CIO is soon going to be considered one of the C-suite “triumvirate,”: CEO, CIO, CMO.

Another reason the CIO role is more difficult than most is that it bears sole responsibility for ensuring business continuity through critical service level agreements that define uptime, availability and redundancy. At the rate of change today—BYOD and big data come to mind, besides the emphasis on ever-changing end-user demands and satisfaction—it’s a lot to juggle at once. Not to put too fine a point on it, the CIO is answerable in a very tangible way to every executive in the C-Suite as well as the end users, both internal and external.

Mary Shacklett, former CIO of FSI International and current president of Transworld Data says this about the role of the CIO today, “. . . virtually every aspect of the business these days is run on systems. When systems fail, even if the wrongdoing originates in business operations, the CIO is still a ‘best bet’ lightening rod to attract the blame.” Here Ms. Shacklett is responding to the resignation of Target’s CIO after the data breach last fall. To my mind, blaming the CIO underscores the notion that IT is still perceived mainly as the supplier of technology and that with the right technology, incidents like this would not happen. But this is patently not true. It cannot be the CIO’s job to absorb all the operational risk.

It is past time to realize that risk management is critical to your operations and adequate overhead should be provided for it. Preventative measures such as performing regular maintenance and security checks is not the place to economize; economies can be made by killing unnecessary demand and scrapping any projects that have either outlived their usefulness or whose value is questionable or negligible. Give IT the budget it requires to undertake the discipline, training, and governance necessary to do the job right. Data and operational security should always take precedence over functionality improvements if you are faced with budgetary constraints.

The U.S. economy for the past few years has been unkind to IT, and now that there seems to be a slight improvement, organizations will be making some overdue upgrades to their hardware, servers, and storage systems. IT will be at the forefront of these efforts as well as efforts to move to the cloud, coordinate the use of employee mobile devices, mine data, and maintain security. I read somewhere that the CIO is not unlike a conductor, orchestrating separate sections into a synchronized whole. I think that’s about right.

Give me your thoughts on how you see your CIO role. How are you/they addressing these challenges? Does the world look different from where you sit? What would you do if you were CIO or CISO?

Making decisions means risking what is known for what is not. In my line of work, I have seen many organizations mired in keeping the status quo because the bogeyman in the hall is whispering, what if you’re wrong? The irony, of course, is that by not making a decision—right or wrong—you end up doing nothing, and this poses a far greater risk because your competition is certainly doing something. ​

Fear of the unknown and fear of being wrong are formidable inhibitors to decisive action. There are others, such as a reluctance to be held accountable, but even that is anchored in fear. Another inhibitor is being overwhelmed by the number of factors involved: the people who will be affected, the processes that will change, available resources, and so forth—aspects I call the “what.” The “why” of a decision is the part usually easily identified; Something has driven the case for change. It may be an eroding top line, a dissatisfied customer, excessive overtime, the competition, or staff malaise. But how to address the “what”—that becomes the immovable object stopping many decision-makers from acting quickly and decisively. Often, they feel compelled to have all the answers before embarking on any course of action. Unfortunately, seeking those answers, they usually consider the internal ramifications—conditions within their control—and neglect those coming from external sources such as the market, competition, technological advances, etc. And those considerations don’t wait.

This is why Change Management is an important weapon in your arsenal against indecision and inaction. Change Management builds the business case by objectively assessing what is versus what should be and engages the organization in why it is good for them. It garners the right sponsorship and builds coalitions; it demands commitment and ferrets out resistance; and it focuses the entire organization on a singular goal. Change Management is grounded in communication—communication that is clear, consistent, and candid. Change Management champions intellectual honesty and trust, and encourages open dialogue and debate that fosters buy-in and mitigates the possibility of decisions being undermined.

Theodore Roosevelt got it right: “In any moment of decision the best thing you can do is the right thing, the next best thing is the wrong thing, and the worst thing you can do is nothing.” Decisions should evolve; they should never be made in a crisis. Making decisions is a daily event. If you don’t make the small ones today, you will have to make a big one tomorrow—chances are, it won’t be pretty.