ISG Provider Lens™ Life Sciences Digital Services - Clinical Development (CROs) - Global 2025

Life sciences is strategically reinvented through digital, patient-centric and intelligence-driven approaches

The life sciences industry is undergoing a profound transformation, shaped by digital disruption, patient-first innovation and an unrelenting drive toward operational sustainability. Service providers that lead in this space are moving beyond traditional models by embracing AI, generative AI (GenAI), IoT and advanced analytics to reimagine value delivery across clinical development, manufacturing, commercial operations and patient engagement. At this pivotal juncture, the strategic imperative is clear: those who embed intelligence, interoperability and inclusivity across their value chain will accelerate innovation and redefine outcomes.

Agentic AI is swiftly becoming a cornerstone of transformation in life sciences, propelling the industry toward more intelligent, autonomous operations. Integrating AI-driven agents across clinical development, patient engagement
and regulatory affairs, organizations are moving beyond traditional automation to create self-learning systems that continuously optimize processes. These intelligent agents are enhancing decision-making by providing real-time, data-driven insights, predicting patient needs, streamlining clinical trials and ensuring compliance with evolving regulations.
As a result, agentic AI is accelerating innovation, improving outcomes and enabling organizations to navigate the complexities of a rapidly evolving healthcare landscape with unparalleled efficiency and precision.

Clinical development: Intelligence meets inclusion

The clinical development landscape is transitioning into an era defined by speed, precision and patient-centricity. AI-powered platforms are being used to accelerate protocol design and transform oversight and documentation. Real-time data capture, synthetic control arms and cloud-native architectures are enabling trials that are smart and responsive to real-world dynamics.

However, the most transformative change is the redefinition of a patient’s role. Decentralized and hybrid trials, supported by telemedicine, wearables and virtual platforms, are enabling broader participation and inclusive research.
The result is a trial experience that is no longer site-bound but seamlessly integrated into patients’ lives.

To succeed, organizations must build ecosystems that unify AI, automation and human-centric design, balancing operational speed with ethical responsibility. 

Patient engagement: From communication to connection

The patient engagement ecosystem is evolving into a dynamic, technology-driven landscape where patients are no longer passive recipients of care, but cocreators of their health journey. Leading service providers are deploying AI, telehealth platforms and personalized communication strategies to build continuous, proactive relationships with patients. The shift toward decentralized engagement and real-time feedback loops is improving retention, adherence and satisfaction, especially as digital tools offer multilingual, accessible and tailored experiences.

The future lies in platforms that go beyond merely informing patients and adapt to their needs. In this emerging paradigm, enterprise CIOs must prioritize investments in digital empathy — solutions that listen, learn and evolve.

Manufacturing: Smart, sustainable and adaptive

The manufacturing domain within life sciences is being redefined through the integration of Industry 4.0 technologies. AI-driven predictive maintenance, IoT-powered monitoring systems and cloud-based automation are now essential to delivering resilient, efficient and ethical operations. Service providers integrating analytics with sustainability and ensuring transparency from raw materials to final delivery stand out in this domain.

As consumer expectations evolve and regulatory scrutiny intensifies, smart manufacturing is no longer optional and has become a strategic necessity. Companies must move toward intelligent, adaptive systems that enable both cost savings and environmental stewardship.

Pharmacovigilance and regulatory affairs: From compliance to intelligence

Pharmacovigilance (PV) and regulatory functions are no longer isolated silos; they are becoming digital nerve centers for safety and market agility. Intelligent automation, AI-based surveillance and real-time regulatory intelligence are transforming how organizations process safety data, submit documentation and stay audit-ready.

Leading service providers are leveraging AI for Individual Case Safety Report (ICSR) management, predictive signal detection and case triage. Regulatory platforms, in turn, are enabling real-time dossier updates, submission tracking and cost-effective lifecycle management. This new digital backbone ensures that compliance becomes a strategic
lever for speed and scalability.

Commercial operations: Personalization at scale

Commercial operations are entering an era where relevance and speed are non-negotiable. Leading service providers are using AI and GenAI to optimize every facet of sales, marketing and CX, driving smarter, faster and more personalized engagement than ever before. Omnichannel strategies have become the norm rather than exception, while valuebased models align closely with patient and provider expectations.

In this environment, agility and compliance must coexist. AI-driven insights enable tailored messaging, while automation ensures that operations remain compliant amid shifting global regulations. In this context, success is
defined by precision and not volume.

Contract research organizations (CROs): Integrated partners for accelerated innovation

From being transactional vendors to becoming full-spectrum innovation partners, CROs are redefining their role in the life sciences ecosystem. Their reach now spans clinical development, patient engagement and PV/ regulatory affairs, fueled by AI platforms, digital trial capabilities and therapeutic expertise.

Clinical development: Adaptive, accelerated and insight-led

CROs are at the forefront of modern trial execution. They are leveraging predictive analytics, decentralized clinical trial (DCT) models and flexible staffing structures to deliver smarter, faster and more inclusive trials than ever before. With AI-driven workflows and real-time oversight platforms, CROs ensure that trials are both efficient and compliant, 
unlocking new opportunities for speed to market.

Patient engagement: Digital, diverse and human

CROs are transforming patient experiences in clinical trials using electronic patient recorded outcome (ePRO) tools, mobile apps, virtual assistants and multilingual engagement platforms to ensure that participation is frictionless and
inclusive. With feedback loops and personalized communications, they are improving patient satisfaction and trial outcomes.In a decentralized trial landscape, this approach is critical.

“In a decentralized world, patient engagement is not an option — it’s the engine of trial success.”

PV and regulatory affairs: Globally agile, digitally precise

On the compliance front, CROs are embedding intelligent automation into ICSR processing, safety case management and end-to-end regulatory submissions. Their global-local approach, combining deep regional insights with real-time regulatory tools, helps clients navigate complexities with confidence. Offering integrated PV and regulatory  ecosystems, CROs are helping sponsors avoid silos, reduce risk and enhance readiness.

Strategic outlook: Embracing the future of intelligent, patient-first life sciences

The convergence of AI, patient-centric design and evolving regulatory dynamics is reshaping the rules of engagement in life sciences. Whether in clinical trials, patient outreach, manufacturing or compliance, success will be defined by speed, empathy and intelligence.

To thrive in this landscape, enterprise leaders must:

• Invest in interoperable, AI-enabled platforms that provide visibility and automation across functions

• Prioritize inclusivity and human-centric design in patient engagement strategies

• Ensure compliance serves as a driver of acceleration rather than merely a gatekeeper

• Embed adaptability and sustainability into manufacturing and commercialization models

The leaders of tomorrow will not just respond to change; they will shape it. In this new era of life sciences, speed is no longer enough — being proper, responsible and radically human is of great importance.

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