In 2025, as pharmaceutical sponsors push for faster, more efficient, and patient-centric drug development, CROs must move beyond traditional service delivery models. Embracing digital-first strategies is essential for staying competitive, compliant, and connected to the needs of patients and regulators alike. This article explores the top five digital transformation priorities CROs must focus on this year to future-proof their operations and elevate their role in the clinical research ecosystem.

Accelerating R&D with AI and Machine Learning

The traditional R&D model is under pressure owing to several changes in the clinical trial field. 

• Time-to-market pressures from sponsors
• Volume and complexity of trial data
• Demand for real-time insights to adapt protocols mid-study
• Rising cost of failed trials, often due to poor design or patient mismatch

AI helps tackle these by offering predictive, adaptive, and scalable solutions.

Target Identification and Drug Discovery

AI platforms powered by generative AI are being used to mine biomedical literature, omics data, and historical trial data to identify promising drug targets and repurpose existing compounds.

BenevolentAI used machine learning to identify baricitinib, an existing rheumatoid arthritis drug, as a potential COVID-19 treatment—leading to accelerated clinical trials and eventual approval.

Clinical Trial Design Optimization

AI models simulate trial protocols and predict dropout rates, recruitment challenges, and endpoint efficacy. This enables CROs to design smarter trials that are more likely to succeed.

IQVIA’s Trial Design Simulator uses AI to test protocol variations in silico, helping sponsors choose designs that maximize statistical power while minimizing patient burden.

AI-Powered Patient Recruitment

Recruitment is often the costliest bottleneck in trials. AI tools now analyze EHRs, social data, and demographics to match eligible patients with ongoing studies faster. Generative AI analyzes patient EHRs and consent forms to automatically match exclusion and inclusion criteria.

Mushroom solution leverages NLP to parse patient medical histories and match them with relevant trials, significantly reducing recruitment timelines for CROs and sponsors.

Real-Time Data Monitoring & Risk-Based Monitoring (RBM)

ML algorithms help CROs flag safety signals, detect protocol deviations, and automate site risk assessments—shifting from reactive to proactive trial oversight.

Mushroom Solutions SDTM analytics applies ML to identify anomalies in site data, reducing the need for manual monitoring and improving trial quality and compliance.

By adopting AI and ML, CROs are reducing trial planning time, improving recruitment accuracy and speed, enhancing protocol adherence and data quality

Scaling Decentralized and Hybrid Trials

Clinical research is rapidly embracing Decentralized Clinical Trials (DCTs) and hybrid models to increase trial accessibility, boost retention, and increase patient diversity. Site-only trial sites are marred with adversities leading to cost and time inefficiencies. DCTs offers the following benefits:

Remote Patient Monitoring with Wearables & Sensors

CROs are using FDA-approved digital health tools to monitor patient vitals, adherence, and adverse events without site visits.

Pfizer’s collaboration with Fitbit enabled the remote tracking of patient activity and sleep patterns in long-COVID studies, improving data continuity and reducing patient burden.

Home Health Visits & Mobile Phlebotomy

Trained healthcare professionals conduct assessments, sample collection, and drug administration at patients’ homes—ensuring protocol adherence and improving comfort.

Science 37, a pioneer in decentralized trials, reported that remote visits via mobile nursing increased retention by over 25% in CNS and rare disease trials.

Telemedicine and eConsent Platforms

Patients can now enroll, consult with investigators, and provide informed consent digitally—streamlining trial onboarding and boosting participation from underserved communities.

Mushroom Solutions, a DCT platform provider, reported a 40% reduction in trial timelines when eConsent and telehealth tools were integrated into oncology studies.

Site-less Trial Models for Niche Populations

For trials targeting rare diseases or rural geographies, site-less or “virtual-first” models are expanding reach and enabling patient-first participation.

Verily’s Baseline Platform supported a site-less sleep study across the U.S., enrolling participants via digital ads, remote screening, and app-based data capture.

Strengthening Regulatory Compliance and Data Integrity

In an increasingly digitized and globalized clinical trial ecosystem, data integrity and compliance are crucial. Regulators demand transparency and security in participant data handling.

End-to-End Digital Audit Trails

Modern clinical platforms now automatically capture every data touchpoint—who accessed what, when, and why—creating defensible logs for regulators.

CTOPs provides real-time audit trails across all eClinical modules, allowing sponsors and CROs to track compliance deviations before they become regulatory issues.

AI for Risk-Based Monitoring and Quality Oversight

AI is being deployed to flag anomalies, identify high-risk sites, and prioritize monitoring activities—supporting a more targeted, cost-effective approach to compliance.

Blockchain for Data Immutability and Trust

Some CROs are experimenting with blockchain to create tamper-proof, timestamped records that assure regulators of data authenticity—especially in decentralized trials.

Boehringer Ingelheim ran a blockchain pilot in a clinical trial with IBM to track consent and data collection, ensuring immutable records for future audits.

Digital Regulatory Submissions & IDMP Readiness

Automating regulatory submissions with structured content management and AI-assisted metadata tagging ensures faster, cleaner interactions with authorities.

IQVIA SmartSolve offers end-to-end support for digital submissions, ensuring traceable compliance with evolving regulatory standards like IDMP and eCTD 4.0.

Digital compliance tools de-risk operations and increase the CRO’s value as a strategic, audit-ready partner.

Unlocking Real-World Evidence (RWE) and Post-Market Surveillance

Real-world evidence (RWE) is a regulatory and commercial imperative in 2025. CROs must facilitate continuous collection, curation, and analysis of real-world data (RWD) across the product lifecycle. This is driven by several factors.

• Payers want data on effectiveness, not just efficacy
• Regulators seek long-term safety insights beyond trial endpoints
• Patients demand real-world insights into treatment outcomes
• Pharma is shifting toward lifecycle evidence strategies that go beyond Phase III

CROs are now critical players in bridging the gap between clinical research and real-world outcomes.

Longitudinal Studies for Post-Market Safety

CROs design and manage long-term observational studies to assess safety and effectiveness in diverse populations.

Example: PRA Health Sciences (now part of ICON) led a 5-year global observational study tracking cardiovascular outcomes for a marketed diabetes drug, helping validate its long-term safety profile.

EHR and Claims Data Integration

CROs are integrating electronic health records (EHR), pharmacy claims, and lab data to generate RWE without launching new trials.

IQVIA’s E360™ platform aggregates and analyzes data from over 1 billion patient records globally, allowing CROs to generate real-time insights on drug performance, adherence, and safety.

Regulatory-Grade RWE Submissions

RWE is being structured and analyzed to meet regulatory-grade requirements using standardized formats (e.g., Sentinel, OMOP CDM).

The FDA’s approval of Ibrance (palbociclib) for male breast cancer was supported by RWE sourced from Flatiron Health and IQVIA’s oncology datasets.

Hybrid Trial Designs with Embedded RWE

Some CROs are designing pragmatic or hybrid trials that combine randomized elements with real-world data sources to improve external validity.

Veradigm and Labcorp[MC1]  are collaborating to create hybrid study models that combine RWD with clinical trial protocols—allowing sponsors to collect both efficacy and effectiveness insights in a single study design.

Designing Patient-Centric Trials for Better Engagement

30% of patients drop out of trials due to burden or poor experience. Patients are no longer passive participants and expect to be treated as stakeholders in their health journey. As a result, CROs are under pressure to design trials that prioritize the patient experience.

CROs Are Embedding Patient-Centric Approaches

Flexible Trial Participation Options

Offering hybrid schedules, home health visits, and remote data capture empowers patients to participate on their terms.

ICON plc launched oncology studies with at-home infusion and mobile nurse visits, improving enrollment rates among immunocompromised patients.

Inclusive and Culturally Sensitive Protocols

Patient-centricity also means reflecting the diversity of real-world populations. That requires addressing language barriers, transportation needs, and digital access gaps.

Example: Janssen’s “Trials2You” initiative, co-developed with patient advocacy groups, localized outreach materials and consent forms in multiple languages, leading to improved engagement in Hispanic and Black communities.

Digital Engagement and Communication Tools

CROs are using mobile apps, chatbots, and SMS reminders to keep patients informed and motivated—while also collecting PROs (Patient-Reported Outcomes) in real time. Generative AI-powered chatbots automatically responds to participant queries in natural language improving patient satisfaction.

Medable’s digital trial toolkit includes a virtual assistant that reminds patients about medication schedules, site visits, and symptom tracking—boosting both retention and data quality.

Patient Advisory Boards and Co-Design

The most forward-thinking CROs involve patients in protocol design through advisory boards and usability testing—resulting in trials that are not just feasible, but truly user-friendly.

Parexel established formal patient advisory panels to co-create protocols, resulting in trial materials that were simpler, shorter, and more aligned with patient preferences.

CRO Gains from Patient-First Design

• Faster and more inclusive recruitment
• Higher compliance and data completeness
• Lower dropout rates
• Enhanced sponsor perception and trial reputation
• It’s no longer about just enrolling more patients—it’s about enrolling the right patients and keeping them engaged.

Conclusion: CROs Must Lead the Next Chapter of Clinical Research

The message is clear: In 2025, CROs are expected to be digital-first, patient-focused, and outcomes-driven partners—empowering sponsors to accelerate innovation without compromising on compliance or quality.

From integrating AI into trial design to scaling decentralized models, ensuring real-world data readiness, and putting the patient experience front and center—these five priorities are now strategic essentials for CROs aiming to stay relevant and competitive in a rapidly evolving ecosystem.