For biotech companies engaged in the clinical development of a therapeutic innovation, securing investor trust is as critical as demonstrating the scientific value of their molecule. One powerful yet underleveraged asset in this journey is the early implementation of electronic Patient Reported Outcomes (ePRO) in clinical trials.
By capturing the patient voice directly, ePRO, and electronic Clinical Outcome Assessments (eCOA) in general, offer real-time insights into patient symptoms, treatment satisfaction, physical, mental, emotional, and social well-being as well as overall quality of life.
In today’s competitive biotech landscape, where early-stage companies must prove both scientific merit and strategic readiness, PROs offer a unique advantage: by capturing the patient experience, PROs not only enrich the clinical narrative but also help de-risk clinical development. Their use also demonstrates a certain level of organizational maturity of the company. For investors, this translates into greater confidence in the therapeutic potential, operational rigor, and market preparedness of a biotech company, all of which are important criteria to investors evaluating early-stage biotech opportunities.
Why does ePRO matter to investors?
ePRO for greater confidence in the therapeutic potential of the molecule
Integrating PROs early in the clinical development process allows biotech companies to generate rich, patient-centered evidence that highlights the real-world impact of their therapies.
- By capturing symptoms, quality of life, and physical and emotional functional status data directly from patients, PROs provide direct patients insights, which represent a more nuanced and complete understanding of how a treatment affects daily living. These data complement objective clinical, biological, and imaging data by proposing a perception of the impact of a treatment on the patient’s own quality of life, which is increasingly considered by regulatory authorities prior to granting marketing authorization.
- Also, by capturing such patient insights, PROs help to characterize the toxicity profile of the treatment under investigation. When using solid eCOA strategies, the collection of early, structured, direct patient inputs allows more accurate and complete detection of safety signals and potential tolerability issues, which may be seen as a powerful risk management tool.
- On top of helping to characterize the toxicity profile of the treatment under investigation, ePRO data help to improve the design of future studies, resulting in fewer patient dropouts and better trial adherence, increasing the likelihood of trial success and ultimately reducing uncertainty. eCOA contributes to a more efficient and lower-risk path to market, an advantage that resonates strongly with investors evaluating the viability of early-stage assets.
By providing all these benefits, PROs help to derisk the overall clinical development process, and with carefully planned operational strategies will enhance the chances of clinical trial success.
ePRO to optimize operational strategies without increasing costs
While PRO does represent an upfront investment, it ultimately drives a reduction in overall costs, especially when collected electronically via ePRO.
- ePRO systems provide structured, time-stamped, and regulatory-compliant data that enhance the credibility of clinical results. This is particularly valuable for meeting regulatory expectations, and particularly important for early-stage biotechs seeking to demonstrate data integrity to investors and partners. This helps showcase patient-centric innovation, and support due diligence with clean, auditable datasets that reduce risks.
- Through real-time data collection and thanks to the instant availability of the data, ePRO allows regular patient monitoring and streamlines data management and analysis, which helps reduce the clinical trial duration.
- For ePRO set up activities that cannot necessarily be streamlined due to fixed turnaround times for questionnaire translations and copyright holder approvals, experienced and flexible ePRO providers will be able to manage parallel start up activities and will partner closely with the biotech clinical team to manage all the logistics and administrative work for them.
Collecting patient data electronically means less paper, automated patient follow-up, fewer unnecessary visits, and reduced data reconciliation. This also leads to lower patient dropout rates and better trial adherence thanks to automatic reminders, portability, and a smooth digital interface. Such advantages are also key drivers in fundraising discussions.
ePRO as a sign of maturity and strategic readiness of the biotech company
Incorporating PROs into early-stage clinical development is not only a scientific choice but also a strategic one that reflects the maturity of a biotech organization. It demonstrates a data-driven culture, a commitment to rigorous methodology, and a forward-thinking approach to evidence generation.
- By aligning clinical data with endpoints that matter to patients, companies show they are already thinking beyond regulatory approval toward market access and payer expectations. This readiness to generate pharma-compatible, real-world data strengthens investor confidence, positioning a company as a credible, well-prepared partner capable of navigating the full development lifecycle.
- This is also key when negotiating licensing deals or co-development agreements, and for engaging with larger pharma companies that expect digital readiness. During an IPO process, a solid eCOA strategy helps to provide solid evidence of the benefit/risk ratio of a new treatment and helps to justify a company’s valuation.
“A biotech company that adopts eCOA solutions early in its development is a sign of an organization that anticipates market access and is committed to structuring real-world data as early as possible. As an investor, this is a very reassuring marker, as one of the key reasons for biotech failure is precisely the lack of anticipation around market access.”
Partner in a top European biotech fund
In today’s competitive biotech environment, where early-stage companies must prove both scientific merit and strategic foresight, ePROs offer a decisive edge. For investors, the early integration of ePROs demonstrates more than just a commitment to patient-centricity, it reflects operational maturity, data-driven rigor, and a clear vision for market access. By bridging clinical development with real-world relevance and economic value, ePRO helps biotech companies tell a more credible, differentiated story, one that not only validates their science but also strengthens their case for funding.
