Curing data management problem in pharmaceutical industry

A large pharma firm can have tens or hundreds of thousands of employees in offices all around the globe; furthermore, there is the sheer variety of different departments and roles within the organisation, encompassing chemists, pharmacists, biologists, patent attorneys, marketing, legal staff and many more.

These different departments all generate huge amounts of data, contained within reams of digital documentation. Indeed, one major European drug manufacturer recently admitted that its data volumes are doubling every 15 months. The problem facing pharmaceutical companies is that much of the data generated by different departments is needed across the organisation; however, it is often extremely difficult, if not impossible to share this information between different people, premises and departments.

Nor is internal data sharing the only issue. The pharmaceutical industry is also unique within the private sector for the close scrutiny and complex regulation to which it is subject. While this level of bureaucracy is necessary for ensuring the highest standards of public health and safety, it can cause major headaches for pharma companies when they are required to provide information, such as clinical trial data or audit trails, to external authorities.

The problem stems from the multiplicity of different software and systems in use across all the different departments within a large pharma organisation. Naturally, this goes far beyond the word processing, spreadsheet and presentation applications used by ordinary businesses. For example, the chemists alone can use around 200 separate pieces of highly specialised software to design, refine and test drugs; including biomolecular modelling, semi-empirical, molecular mechanics and valence bonds programs, to name just four types. Unsurprisingly, these software applications are not supported by off-the-shelf collaboration tools like Microsoft SharePoint.

All these different applications use different codes, languages and standards, and it is usually either extremely difficult or completely impossible to share and integrate content between them. Yet even if there were one single standard for content, pharma companies would still have to overcome the problems inherent in the complexity, size and geographic diversity of their operations. In large, complex organisations like these, valuable data and content are usually siloed in a plethora of different machines, desktops, servers, premises and, potentially, even in different countries and continents.

The difficulties involved in finding, obtaining and integrating data slows still further the long process of getting a new drug or device onto the market. And, like any delays, they are harming pharma firm’s profitability.

The information management needs of the industry require more specialised collaborative working systems that generic software used by other businesses. But while most, if not all, pharma firms have specialised enterprise content management (ECM) technology, even systems specifically-designed for the pharma industry are rarely more than a suite of off-the-shelf components.

At a recent roundtable held by Open Text, senior players in the pharma industries highlighted several key challenges that traditional ECM software has so far been unable to solve. One of the issues raised was the management of regulated content – in other words, data collected and submitted to regulatory authorities or subject to legal, regulatory and ethical constraints, such as medical records. It’s vital that access to regulated content is restricted to those with legitimate authority to view it; at the same time, this information must be structured and searchable to ensure that information can easily be found when it is requested by outside agencies – such as regulators, auditors, investigators or insurers.

Another concern highlighted at the event was the issue of data integration. This needs to be done in a federated manner by introducing data exchange standards and introducing a semantic layer to facilitate navigation and data recall across the multitude of different systems and formats.

Closely related to this issue is the challenge of managing content itself, rather than just the documents in which that content resides. The inability to access or share data across an organisation means that it is often very difficult to find, access and re-use the ‘intelligence’ within pharma companies’ legacy documents. This slows down document workflow, as well as any associated auditing process, which ultimately slows down the time-to-market of the products involved.

These were only the standout issues raised at Open Text’s pharma roundtable, and there were many other problems raised and discussed at the event. But if there was one theme that united many of the problems identified, it was the urgent necessity of semantic, or ‘sense-making’ technologies that enable users to find relevant content quickly and easily, wherever it may reside in the organisation.

As noted above, there are a number of different content management technologies specifically designed to meet the needs of the pharma industry. Yet the fact that the roundtable attendees were able to identify – and agree on – several significant content management difficulties speaks volumes about the failure of these systems to meet pharma firms’ requirements.

While there is no single silver bullet, no overarching technology suite or process methodology available for solving these problems, doing nothing and sticking with the same old systems is merely a counsel of despair.

What, then, is the answer? Open Text believes that pharma companies cannot simply wait around for technology providers to come up with a panacea to all their problems. Content management vendors can produce systems for separate business functions, departments and processes; but if we are to solve the wider issue of effective data sharing across the whole organisation, a new, holistic approach is needed. This can only be achieved with the direct input of pharma firms themselves.

The industry therefore needs to engage actively in the development of new standards, processes and technologies. They can best do this by working closely with content management vendors to help identify the specific challenges they face in creating, managing, auditing and sharing the superabundance of invaluable data that they hold.

No content management vendor can truthfully claim to have the answer to the multitudinous issues surrounding information management in this industry. Nor will they, unless they begin reaching out to pharmaceutical companies; listening to their experience; and fully understanding their needs.

This will not be a quick win; and pharma firms should know they cannot expect a miracle cure to appear overnight. But the prize is one of real and lasting value: an holistic information management system that will transform data sharing across organisations, leading to more rigorous safeguards, faster time-to-market and increased profitability. It’s imperative that the industry starts to take responsibility for coming up with effective data management systems; because the current dearth of such technology shows the unwisdom of inaction.

— Matt Mullen, senior solutions consultant (Semantic Technologies) at Open Text