Biopharma chief scientific officers and research and development leaders face huge pressure to fix productivity issues and develop new drugs radically faster and more efficiently—with good reason: Therapies born out of clinical development save countless lives every day. Finding ways to accelerate the development pipeline is critically important—and leveraging data and predictive analytics now offers real and new opportunities to do so. Recently, the global Clinical Development Leadership of EMD Serono’s Research and Development Institute, an affiliate of Merck KGaA, Darmstadt, Germany, engaged Accenture on a project to transform the way the company designs and executes clinical trials. With the rise of data sets and technology platforms the time was ripe to build an internal capability that leverages analytics and data to predict and optimize the operational feasibility of a trial. Not only that, they wanted to increase the probability of success in order to optimize clinical investments.

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Together with Accenture Strategy, EMD Serono navigated the complex transformation journey of building a specialized in-house analytics capability that will catapult the organization to the forefront of clinical trial design—positioning them as a leader in digital R&D.

Strengthening clinical and financial outcomes through an operational design center

As a large share of R&D cost is derived from clinical trial execution, developing innovative models that access new technologies by unlocking the power of data, you have the potential to mitigate biopharma’s risk exposure, while getting more effective therapies to patients quicker and at a lower cost.

The healthcare sector today has amassed reams of unused data, sourced from individual patients’ medical records, reports from clinical trials, trial management systems, as well as countless other sources of secure digital information from various geographies. The challenge isn’t collecting the data—it’s how to build trust in effectively accessing and analyzing it to unlock hidden potential.

The EMD Serono transformation project created the Operational Design Center (ODC). We helped EMD Serono assess and begin to ingest a wide range of internal and external data, which is subject to a number of different regulations and industry standards. This complexity meant the target model had to be adaptive and account for different data types. Additionally, together we developed processes that would help EMD Serono retrieve the right data in order to optimize results.

This capability can control critical parameters of the trial protocol and deliver value from health data, using advanced, predictive analytics that enable EMD Serono to accelerate the drug development process.

Applying operational intelligence

“EMD Serono’s transformation journey is rooted in the overall strategic priorities of the R&D organization,” explained Marcy Kravet, Head of the Operational Design Center in a recent conversation. "As a leading science and technology company, we are committed to evolving the design and implementation of our clinical studies using data and advanced analytics. We believe these efforts will bring about a more efficient and patient-focused operating model.”

This holistic approach allows EMD Serono to navigate the core challenges of clinical trial design, answering key questions relating to patient pools, physician and clinical availability, timelines and more. However, clinical analytics capabilities are not only about new tools and technologies, it can be rather thought of as an integrated ‘Intelligence’ applied to clinical development.

Delivering results

Accenture Strategy’s work with EMD Serono allows them to:

  • Invest in new drug development with greater confidence, increasing the probability of operational success of the trial.
  • Provide valuable insights to enable pipeline decisions that are evidence-based.
  • Shorten enrollment timelines and—by that—improving access to treatment for critically ill patients.
  • Drive efficiency in the execution of clinical studies providing substantial savings from annual budgets

Truly innovative clinical operations consist of an important cross-section of talented people, with the right clinical data science skills embedded into a well-functioning clinical governance model. The work Accenture and EMD Serono embarked upon, demonstrates how life sciences teams can jointly navigate complex challenges in a turbulent industry through smart design and collaboration, to deliver industry goals.

Marc P. Philipp

Managing Director – Accenture Strategy, Life Sciences

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