Authored by

Jim Routt, Chief Operating Officer, IQVIA Biotech

Barbara Arone, M.D., Vice President, Real World Evidence Solutioning & Project Leadership Team, IQVIA

For biotech and emerging biopharma, every clinical development decision carries weight. Lean teams, limited capital and aggressive timelines demand strategies that balance speed with scientific rigor while generating evidence that resonates with regulators, payers, investors and future partners. As development grows more complex, real-world evidence can bring greater confidence and clarity to clinical trials.

When integrated early, real-world data and analytics can provide crucial information around current unmet needs as well as treatment pathways, important information when looking at protocol design. For biotech, that means smarter planning, more feasible study designs and stronger alignment between clinical development and downstream evidence needs.

Designing more feasible trials with real world evidence

One of the biggest trial challenges is the gap between protocol intent and execution. Eligibility criteria that seem reasonable can limit patient availability in practice. Real-world data helps sponsors assess those risks before a trial begins.

By analyzing patient populations, treatment patterns and care pathways, sponsors can see how many patients truly meet proposed criteria and where they are treated. That insight helps teams refine inclusion and exclusion criteria, assess geographic feasibility and identify experienced sites earlier in planning.

Earlier evidence planning helps biopharma build stronger clinical, regulatory and commercial narratives.

Real-world evidence can help shape endpoints, comparators and site strategy, making trials more relevant to routine practice and more feasible to execute.

For biotech companies, this upfront validation can reduce the likelihood of enrollment delays, mid study amendments and missed milestones. The result is trial designs that are more achievable, more representative and better positioned to succeed in real world conditions.

Improving operational predictability and trial performance

Beyond study design, real-world data also strengthens operational planning and execution. Historical performance data across therapeutic areas, sites and regions can inform more realistic timelines and expectations, helping teams anticipate challenges.

Sponsors gain visibility into factors such as screen-failure rates, patient flow and site productivity, enabling more proactive risk management throughout the trial lifecycle.

For emerging biopharma organizations with limited internal infrastructure, this level of predictability is especially valuable. It helps maintain tighter control over timelines and budgets, improves communication with stakeholders and supports more confident decision making as programs scale.

Supporting broader evidence generation and value demonstration

Clinical trials rarely exist in isolation. For biotech, a single study often must support multiple goals, from regulatory approval to future access, reimbursement and partnering discussions. Using real-word data to understand how care is delivered today, means sponsors can generate evidence that is relevant not only to regulators, but also to payers and prescribers.

This is where integrated evidence generation becomes especially valuable. Rather than building an evidence package solely around approval, sponsors can plan earlier for the information physicians, payers and other stakeholders will need to evaluate adoption, access and appropriate use. That broader lens helps ensure development decisions support not just submission readiness, but future differentiation and market success.

Real-world evidence should be part of clinical strategy.

This forward looking approach is particularly important for companies preparing for a first launch, where clinical trial data plays a central role in demonstrating differentiation and long term value.

Enabling informed decisions across the development lifecycle

Real-world data helps biotech teams weigh trade-offs such as speed versus certainty and focus versus expansion.

When integrated early with clinical and operational plans, RWE can help teams move faster, reduce late-stage risk and adapt as programs evolve. This reflects a broader shift in evidence planning. Sponsors that bring real-world strategy into development earlier are better positioned to build stronger clinical, regulatory and commercial narratives instead of filling gaps later.

As competition intensifies, early, data-driven decisions will be critical. Biopharma companies that integrate Real-World Evidence earlier can strengthen clinical, regulatory and commercial strategy. Explore a more integrated approach in the Insights Brief “Asking the Right Questions at the Right Time”.

Learn how IQVIA Biotech can support your clinical development journey from strategy through execution.