Data is information waiting to happen, but today's global pharmaceutical companies are riddled with data—so much so that their
numerous functions and disparate systems struggle to know what to do with all of it. Worse still, these data are usually disconnected,
duplicated, and, all too often, inaccurate.
Data is generated by the day-to-day activities that take place in each department. Regulatory operations personnel, for example,
produce documents, develop submissions, and file them in for approval. However, a submission begins long before the documents
themselves are created. The process commences with the generation of concepts that get encapsulated into documents, which
ultimately form the regulatory submission. Submissions become part of a portfolio across multiple nations, with concomitant
licenses that must be managed. In most cases, data gathering is managed locally, with regulatory departments drawing on the
minimum amount of information needed to adhere to requirements or track commitments.
What is often missing is the ability to aggregate information across the enterprise so that it can be used to conduct more
predictive work, such as project planning across the portfolio, resource planning, and pre- and postmarketing activities.
In so doing, companies can manage their activities more holistically. Other industries have been quicker to grasp the importance
of information management.
Perhaps one of the best examples is the automobile industry. For example, when problems arise with a particular model, the
manufacturer can respond quickly by linking information with warranty information. When a manufacturer spots a trend, like
a faulty part, it can ensure that its dealers are ready with the new parts and also send out relevant recall letters, thereby
helping to minimize any escalation in cost.
Cost of Failure
Pharmaceutical companies are aware of the data they generate and capture. According to a survey by the consulting group Ovum,
the pharmaceutical industry is ahead of other industries when it comes to adopting enterprise applications, such as customer
relationship management (CRM) and enterprise resource planning (ERP) solutions, but lags behind with business intelligence
solutions such as regulatory tracking and management systems that can harness data productively. Poor information management
can create a bottleneck for companies on multiple levels, as well as add unnecessary cost burdens. Take the cost of storage,
for example; failing to manage data results in the retention of redundant information and records, which occupy storage space
within a system. Then there's the time cost associated with chasing information needed to meet regulatory requirements or
to make a business or strategic decision. One particular problem that company leaders have identified is the use of multiple
terms or definitions to describe one thing, because it may mean that information about a product exists within several systems,
with each system having its own definition. Consolidating this information can pose challenges. Information management aims
to reduce the time it takes for people to locate relevant content and enable them to make confident business decisions based
on informative data.
From a strategic point of view, good information management is what stands between sluggish response times and streamlined
business practices. All of a company's information should be connected. Ideally, submissions flow into licensure, which then
flows into the portfolio. Tracking resources via project planning, the authoring process, the submission process, the application
process, and, ultimately, approval makes it possible to form a bigger picture of how resources are being managed and where
they might best be directed. Companies can use this informational picture for resource prediction across multiple products
and countries. For instance, good information management can concurrently track license renewals, products that are coming
to the end of their patent life, new products entering the market, and the state of current R&D projects. This information
can help answer questions such as:
» Is it in the company's interest to continue marketing a particular product?
» Should the company look for a partner?
» Are there opportunities for a product extension, and what would the market potential for additional indications be?
Good regulatory information management results in a detailed understanding of all the components pertinent to a particular
product. If a problem arises somewhere along the line, it also enables the company to quickly determine what the problem is
and decide on a resolution.