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Formulating a Healthy Drug Development Digital Strategy

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by Frances Grote

Data science. Mobile applications. Cognitive computing. Big-data analytics. Enterprises today have access to capabilities that give them the potential to revolutionize an entire industry, launch whole new revenue streams and reinvent their business model. The possibilities are nearly limitless. But how do we make digital technologies work for our specific business needs? How do we take full advantage of them and – at the same time – control how they impact our customers, employees and organizational goals? Which ones will bring the best return on investment?

According to recent research from ISG Insights, nearly a quarter of enterprises are in production with big-data projects while nearly one-third are piloting big-data initiatives with the intent to deploy. In the next two years, enterprises across industries will likely invest most heavily in big-data analytics, robotic process automation (RPA) and migrating data and applications to the cloud.

Enterprise investments in digital technology have impacted every industry, but the influence of digital technologies in the biopharma industry has especially wide and broad implications. The use of wearables and mobile devices to collect real-time patient data is revolutionizing everything from protocol design to the conduct of post-marketing trials. Indeed, making the drug development process more efficient – increasing productivity by automating back-office processes and streamlining the systems involved in capturing and analyzing patient data – has potentially life-saving consequences.

Traditional biopharma IT environments, like the IT environments of many enterprises in other industries, have been built on ad-hoc solutions. Add to that a proliferation of digital solutions – eConsent, wearables for 24/7 monitoring, mobile apps to manage dosing and compliance – and biopharma project leads often find themselves managing an entire vendor ecosystem. Not only do disparate solutions and providers increase the challenges of managing the digital drug development environment, a lack of enterprise-wise coordination among them also can drive up the cost.

To deliver maximum value, a digital drug development strategy must be well integrated into a firm’s overall IT and operational framework. And the strategy should be focused on those areas that deliver the greatest return on investment for the target customers – whether they are internal or external. Two of the biggest digital opportunities in drug development are improving the patient experience and improving productivity.

Improving the Patient Experience

Much of this opportunity begins with connectivity. Mobile healthcare services – or telemedicine applications – now use mobile devices to connect with patients and investigator sites, and to collect community and clinical health data. By remotely monitoring patient vital signs and delivering that information to practitioners and researchers in real time, it’s possible to create a more closely controlled trial, a more reliable set of data and, ultimately, a better patient experience. Attempts at improving the patient experience have to be carefully managed, though, as a well-meaning but poorly planned approach to technology can unintentionally increase the patient burden.

A good strategy begins with engaging internal stakeholders to clearly determine what they consider essential requirements and what they consider “nice to haves.” At its most basic, a digital solution must help you create opportunities to connect with patients in a way that optimizes the trial experience and guarantees reliable data. Solutions on the market today include automation, connectivity capabilities and precompetitive ecosystems that leverage models like TransCelerate to build trials on industry standards instead of enterprise standards.

Improving Productivity

At its core, drug development is all the about data, which makes it especially vulnerable to process inefficiency and error. Drug development-specific ePlatforms, such as eDC, eConsent, ePRO and eSubs, are changing the way biopharma companies conduct clinical studies by automating data capture and enabling patients to assess and record their own progress. New Software-as-a-Service (SaaS) offerings can streamline study design, improve consistency and speed up medical coding and data import and export. Companies considering a SaaS product must first ensure it is compliant with regulatory requirements for health and safety. This means, at a minimum, it must include document validation, evidence storage, audit trails and electronic signature recording capabilities.

As trials are digitized, they create a new feedback loop that allows for continuous improvement, so team members and processes can handle mid-course changes if metrics indicate they are required. As a result, for digital solutions to increase clinical trial efficiency, they must be accompanied by proactive change management and continuous communication capabilities. Equally important is a serious investment in ongoing governance for relationships with suppliers.

The first step to building a custom digital drug development strategy is to create a business case that will reliably predict costs, clearly establish the impact on internal resources and budget, guarantee on-time delivery and ensure leadership buy-in. ISG helps biopharma companies find the digital solutions that best fit their needs. Contact me to discuss how ISG can help you.

About the author

Fran works with global and regional biopharma and contract research organizations to streamline and optimize all phases of drug development and clinical sourcing. She helps identify gaps in alignment, implement practices that deliver measurable efficiencies and increase the value of outsourced relationships for all parties. Fran provides both broad insight and specific strategic and operational expertise on clinical outsourcing, service provider selection and engagement, service integration, governance, operational excellence and utilization of metrics.