Clinical Data Strategy – An Experience Driven Perspective

After approaching close to 3 decades of working in pharmaceutical companies, and another decade plus of consulting experience, I like to think that I’ve learned a thing or two. For example, a simple no-brainer is that planning is critical to success. But planning without a strategy is navigating without a compass. Surprisingly, we see a pattern of planning without a strategy all too often. In practice this is understandable, we all have scarce resources and are driven to show results. Consequently, we jump into planning our next initiative while begrudging the amount of time we have to spend planning. We want to roll up our sleeves and get to work. Inevitably, we end up with solutions that address immediate pressing needs, but do not live up to the potential of driving the business strategy forward.

This emphasis on planning has another surprising adverse effect.  When such plans involve the use of new technology, they lead to the generation of a digital strategy. This is a case of the tail wagging the dog. A strategy is now being developed directing technology infrastructure, based on plans that did not adequately factor in the business strategy. This disconnect leads to significant expenditures of time and resources without alignment to the direction of the business.

Now some readers may take exception to this observation. Surely there are organizations that define their digital strategy based on the business strategy.  Absolutely, there are definitely cases where this is true. And some of these cases are quite successful. The successful cases are those that recognize even though the terminology is ’digital strategy,’ the emphasis must first and foremost be put on the data needs, rather than the technology. All technology is merely a facilitator for acquiring data and presenting it in a format that the user can easily interpret as information to drive actionable decisions. In contrast, the unsuccessful ones get caught up in technology for its own sake, delivering solutions that gather dust from lack of use, or worse yet, encourage activities that are not driving the business forward.

To combat these pitfalls, each business unit should develop a forward-looking data strategy in alignment with their contribution to the business strategy. As an astute reader, I’m sure you keyed into the reference to each business unit. This is deliberate, because each unit has their own set of data needs. Some units focus on external data, others internal; some work with structured data sources, others unstructured; some use pristine clean data sources, others struggle with noisy dirty data; some can use the data as is, others require significant transformations to make it usable; some data volumes are relatively small, while others may be ungainly large; some have sophisticated computer savvy users, while others have users who are considerably less so. A one size fits all solution will seldom, if ever, satisfy the range of user needs across business units. From a data strategy perspective, each unit has unique needs that are best served by fit for purpose solutions tailored to their scope of responsibilities, while also able to share and exchange data with the other business units.

It is this focus on the specific needs of Clinical Development, that is why I enjoy working with firms such as eClinical Solutions. Groups of people looking for ways to leverage technology to take greater advantage of hard-earned data in support of the ultimate strategy of bringing new products to market sooner to improve patients’ lives. I recently had the chance to collaborate with Raj Indupuri of eClinical Solutions on a white paper called “The Case for a Clinical Data Strategy” which is now available. In this paper, Raj and I discuss why a data strategy is vital, the key elements of a clinical data strategy and the top five considerations for implementing a successful data strategy. This is the first topic in a series, the next white paper covers the key technology considerations for implementing an effective clinical data strategy.

You can download the white paper here >

Author

Robert Musterer

Vice President, Product Management, eClinical Solutions

A life sciences industry veteran and clinical systems expert, Rob Musterer has over 25 years of experience in clinical programming, biostatistics and data management in large pharmaceutical companies including Bayer Healthcare and Schering-Plough Pharmaceuticals. Rob most recently served as President of ER Squared, Inc., a life sciences consulting firm with an e-clinical focus. Rob began in pharma as a data manager. Seeing possibilities to improve the model, he engaged in early deployments of electronic data capture (EDC) systems and championed the change management required to adopt EDC. Rob has dedicated his career to helping the life sciences industry obtain greater time-to-value from their solutions and break from historical clinical research processes through innovation. His expertise extends far beyond EDC and includes data management services, clinical trial programming, data repositories, data visualization, clinical trial management systems (CTMS), standardization, validation and more.