Accelerating Time to Patient by Unifying Clinical Activities

In biopharma companies, everyone is responsible for delivering value but little attention is given to what ‘value’ is — or how to measure it.

To realize value, all functions need to understand the aspiration and their role in attaining it. Implementing a new system, alongside new business processes, can be an opportunity to communicate your value realization goals.

One global biopharma undertook a multiyear program to transform clinical trials by unifying all relevant activities on the Veeva platform. Bringing in new technology and business processes will help to reduce overall time-to-patient delivery. Shaving off more than 1,000 hours of manual work per trial will lead to time savings between last patient, last visit (LPLV) and database lock, and is projected to shorten the average total study duration by one week. As the company’s senior director for clinical sciences and study management points out, these changes will help achieve the goal of “getting to that weightless state so we can focus on delivering our pipeline and reduce cost while doing it”.

Simplifying to speed up

An important first step is defining your desired end state. For the global biopharma, the goal was to simplify the system landscape and reduce integrations, beginning with a few early-stage studies. At the start of its implementation journey, it already had over 100 late-phase studies and wanted to find a way to reduce manual labor while continuing to execute.

The right value realization framework will address the underlying business question: how can we reduce our cycle time without adding resources? Agility is often critical, as a way of responding more quickly to evolving regulatory, patient, and site needs. This places a new emphasis on data ownership and control and requires seamless data ingestion and end-to-end tracking.

Once your company has defined its expected outcomes and aligned these to business objectives, you’ll need to determine how to quantify and track value over time — including during and after implementing new technology [Figure 1].

Figure 1: Defining the path to value realization

Source: Global biopharma

Focusing on value you can measure

A phased implementation is often favored to maximize the value of the platform as quickly as possible. Input from senior leadership will help sharpen the focus on key objectives: for example, improving platform stability, reducing study and operational costs, or accelerating decisions from partner trials. Each objective should be associated with key results that are leading indicators of success. For instance, insights showing increased data availability suggest that platform access is improving.

At the global biopharma, an initial list of 200 suggested value metrics was shortlisted to the most relevant ones that quantify cycle time, work effort, and related costs. These were grouped by workstream (such as clinical data or platform) and then aligned to specific processes (e.g., EDC study builds, end-of-study processes).

To set measurable and achievable improvement targets, it is critical to identify metric owners who deeply understand the data and the business. By documenting previous pain points and planned changes, teams can then quantify the value future processes would add.

Incremental gains can quickly add up to significant realized value across dozens of processes. At the global biopharma, clinical research associates (CRAs) now see source data verification (SDV) requirements within Veeva EDC, so they no longer need to download reports or apply macros in spreadsheets. Instead, CRAs can focus on what matters.

Figure 2: Value realization at global biopharma

Simplification is another sign of success. Previously, data entry guidelines (DEGs) easily amounted to hundreds of pages; now, in part because of a hover text feature, there are 65% fewer pages for users to read. The team has also consolidated and reduced EDC forms by 37% across its Phase I trials in Veeva EDC. Straightforward improvements to system functionality — such as not requiring users to enter future visit dates — will avoid an estimated 54,000 queries a year.

Advocating effectively for change

Although full value realization takes time, your team should advocate for early and ongoing assessment while adoption scales.

It can be difficult to compare the new environment to the old, so encourage teams to communicate expectations clearly and carefully to the business. “It can be hard to wait, but you need to be patient with value. Explain the roadmap and help them understand when to expect meaningful value,” advises the senior director.

Value cannot be defined in a silo, and every program needs business buy-in to support adoption. It pays to set up early links between your business process and value realization teams. Among them will be some of your most powerful advocates who can convey your story to the broader organization.

Naturally, it will take time for people to embrace change and adapt to new processes. It’s worth including some flexibility as you consider and set targets (for example, distinguishing between ‘interim’ and ‘steady-state’ KPIs), particularly if this is a novel way of operating for some teams.

The senior director concludes: “Recognizing value is dependent on all of the individuals in our project and the business who will be working with the new tools and processes. We’re changing everything incrementally, and in doing so, we can redefine how we work and break down silos.”

Learn how customers are simplifying their technology to speed up drug development.

“It can be hard to wait, but you need to be patient with value. Explain the roadmap and help them understand when to expect meaningful value.” Senior Director for Clinical Sciences and Study Management, Global Biopharma