The pharmaceutical industry is undergoing a fundamental transformation. Traditionally, the
key engines of innovation have been Research & Development (R&D) and Commercial. Yet,
in recent years, Medical Affairs has rapidly evolved to become a strategic pillar alongside
these two functions. Real-world data (RWD), real-world evidence (RWE), and next-
generation technology solutions sit at the heart of this transformation. By unlocking new
insights, improving patient outcomes, and elevating Medical Affairs to its rightful place in
the enterprise, these shifts promise a more dynamic, evidence-driven future for pharma.

The rising importance of medical affairs
In the not-so-distant past, Medical Affairs was often regarded primarily as a support
function – responsible for medical information, publications, and ensuring scientific accuracy. Today, it’s recognized as a driver of healthcare innovation with a strong, strategic voice. As highlighted by McKinsey in A Vision for Medical Affairs in 2025, the role of this function has expanded well beyond answering questions and managing clinical trial outputs – it now serves as the “owner of scientific knowledge and data” across a product’s entire lifecycle.

Medical Affairs teams are uniquely poised to interpret and contextualize medical
information to meet the needs of diverse stakeholders – providers, patients, payers, and
regulators – while supporting data-driven decisions. Armed with expertise in science, in
depth knowledge of clinical practice, and trust from the healthcare community, Medical
Affairs can effectively use RWD and RWE to demonstrate value, improve patient outcomes,
and ultimately forge tighter links between innovation and patient benefit.

“Medical Affairs professionals are emerging as the natural ‘owners’ of scientific
knowledge and data within the organization and across the product lifecycle.”

RWD, RWE, and the power of technology
One of the central forces accelerating Medical Affairs’ evolution is the big volume and
variety of healthcare data being generated. Connected devices, wearables, electronic health records (EHRs), and patient-reported outcomes collectively produce huge amounts of information. Real-world data – those data gathered in routine clinical practice, rather than controlled clinical trial settings – forms the foundation for real-world evidence. Properly analysed, these data help stakeholders understand how treatments perform in diverse, everyday conditions.

Generating more meaningful evidence
Historically, randomized controlled trials have been the gold standard for assessing safety
and efficacy, but they provide only a partial picture – especially around long-term outcomes, rare side effects, or usage patterns in underrepresented patient groups. By adopting advanced analytics, artificial intelligence (AI), and robust data-linkage strategies, Medical Affairs teams can quickly turn RWD into actionable RWE.

This enables:

• Rapid-cycle evidence generation – employing new sources and methodologies – like decentralized trials or real-time data from EHRs – to answer clinical questions faster and more accurately.
• Deep insight into patient populations – understanding how different subgroups
  respond to therapy, helping refine product positioning and personalized treatment
  approaches.
• Compelling value demonstration – providing payers, providers, and patients with evidence of a therapy’s effectiveness in everyday clinical settings, paving the way for better access and outcomes.

Accelerating access and improving outcomes
RWD and RWE are not merely boxes to be checked on regulatory submissions; they are
catalysts that can accelerate patient access to innovative treatments. Armed with robust
real-world insights, Medical Affairs teams help:

• Inform market access discussions – payers now expect evidence of real-world effectiveness and cost-effectiveness. RWE can support pricing and reimbursement negotiations, leading to faster patient access.
• Shape risk-sharing agreements – when therapies show promise in data beyond traditional trials, it opens doors for creative value-based or outcomes-based contracting, benefiting patients, providers, and manufacturers.
• Optimize patient selection – real-time monitoring and analytics can pinpoint the right therapies for the right individuals, helping patients get optimal care sooner.
• Transforming medical engagement – use analytics to understand the specific information needs and treatment priorities of each stakeholder.

Through these approaches, Medical Affairs professionals become strategic partners in
patient care, ensuring that resources, data, and support align with real-world clinical
decision-making.

Stepping up as strategic leaders
To capitalize on these advancements, Medical Affairs teams must also lead internally:

• Elevate medical strategic planning – by integrating RWD/RWE insights into product strategy, Medical Affairs leaders can guide R&D focus, shape market access frameworks, and continually refine commercial messaging.
• Embrace a digital mindset – in an era of digital transformation, Medical Affairs must adopt agile ways of working, drawing on capabilities like data science, AI, and advanced analytics. This often involves forging partnerships with tech firms, startups, or other external collaborators who bring new data sources and expertise.
• Become the voice of the patient – perhaps the key shift is becoming the champion for patients within the organization by capturing patient needs, experiences, and outcomes through RWD and RWE.

How Sqilline Health can help
At Sqilline Health, our mission is to speed up R&D in medicine and improve patient access and outcomes through RWD and AI technology. We support Medical Affairs teams to derive actionable insights and establish themselves as true strategic partners. Through our AI-driven Danny Platform, we help pharmaceutical organizations:

• Analyse clinical RWD to optimize your patient outcomes and deliver personalized and effective treatments.
• Structure clinical RWD to generate scientific insights and publish meaningful research.
• Use clinical RWD to discover new opportunities for clinical trials and enrol more patients.

By blending vast industry expertise, innovative technology, and a collaborative spirit, we support Medical Affairs functions to expand their strategic influence, improve patient outcomes, and shape the future of pharma.

Looking ahead
Real-world data and real-world evidence have emerged as game-changers, giving the
opportunity for Medical Afairs to move from a supportive role to a true strategic leader.
Through data-driven insights and advanced analytics solutions, Medical Affairs teams can
accelerate access to life-saving treatments, deepen trust with providers and payers, and
become the voice of the patient within the industry – ultimately ensuring that every
innovation translates into tangible benefits for the patients who need it most.

At Sqilline Health, we believe this is only the beginning of a broader transformation. By
continuing to invest in analytics, adopting modern engagement strategies, and putting
patient needs first, Medical Affairs will remain at the forefront of these exciting changes –
guiding pharma toward a more connected, transparent, and patient-focused future.

“The winners will be those organizations that succeed in positioning their science – especially their ability to combine, analyse, and interpret disparate datasets – to inform their interactions with stakeholders and ultimately improve patient outcomes.”

Ready to use in practice RWD and RWE? Reach out to Sqilline Health to learn more about our solutions, supporting an evidence-driven and patient-centric future of pharma.