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Design smarter, more efficient clinical trials with predictive analytics, real-world data, and operational feasibility modeling.
Streamline your protocol design for operational feasibility with our Intelligent Clinical Trials solution
Revolutionizing protocol design with data-driven insights
Our Intelligent Clinical Trials solution empowers organizations to leverage the overall potential of their internal and broader cross-sponsor data to help streamline protocol design while maintaining scientific rigor. Through AI-driven insights, our solution can accelerate the protocol design process and results in less complex protocols due to lower patient and site burden and development costs.
Benefits of Intelligent Clinical Trials solution
- Transform complex data into actionable insights
- Improve operational outcomes with enhanced protocol design scenario modeling
- Enhance clinical trial design with an AI-enabled assistant
Transform complex data into actionable insights
Our advanced protocol data digitization engine, enabled by custom NLP and GenAI models, transforms unstructured protocol data into structured datasets enabling precise benchmarking. With over 5,000 protocols digitized across 40+ indications and a 90% extraction and standardization accuracy, sponsors can benchmark their trial designs against industry standards iteratively and quickly identify unique design components leading to increased complexity and lower study feasibility.
Improve operational outcomes with enhanced protocol design scenario modeling
Our Intelligent Clinical Trials solution can deliver strong and iterative protocol design scenario modeling capabilities, enabling sponsors to assess how adjustments in protocol design impact trial cost and operational feasibility like enrollment speed. By leveraging AI-enabled insights and deep clinical team expertise, sponsors receive real-time recommendations on critical aspects of the study design.
Enhance clinical trial design with an AI-enabled assistant
PwC’s AI design assistant feature can streamline trial planning with intelligent data-driven decision making. A built-in AI chatbot, trained on clinical trials and medical publications, assists with trial design decisions and industry benchmarking. This system provides real-time recommendations, proactively suggesting refinements to inclusion or exclusion criteria, endpoints, and schedule of activities to enhance efficiency while maintaining regulatory and scientific integrity.
Insights on protocol complexity
Our Intelligent Clinical Trials solution can empower sponsors with self-service capabilities, allowing them to independently assess critical aspects of protocol design. By benchmarking against industry peers, sponsors can gain deeper visibility into aspects of the protocol driving complexity.
Protocols with overly restrictive or uncommon inclusion or exclusion criteria, a high number of exploratory endpoints—especially those tied to invasive or costly procedures—and a concentration of activities that are rarely used by peer trials but carry significant patient or site burden are flagged as high-complexity. These insights enable sponsors to proactively streamline their designs to improve feasibility, reduce costs, and accelerate trial timelines.
Our customizable and multi-dimensional framework for quantifying patient burden is based on trial participant surveys, focus groups, literature reviews, and clinician feedback. The framework enables the assessment of the impact of protocol design on patient experience.
Understanding the time commitment required from trial participants can be critical for recruitment, retention, and overall patient experience. Our Intelligent Clinical Trials solution enables sponsors to quantify patient time spent on trial-related activities by visit. By benchmarking patient time against similar trials, sponsors can assess feasibility, identify high time-burden activities, and refine protocol designs to improve participation rates.
Our site burden framework can evaluate the impact of trial design on excess administrative workload and site personnel demands. Developed based on a global survey of trial site personnel with recent trial experience, this framework helps identify key drivers of site burden, including regulatory documentation, protocol complexity, digital technology implementation, and staff resource allocation.
Trial protocol complexity directly influences patient recruitment speed and overall enrollment success. Using our AI-enabled scenario modeling and peer benchmarking capabilities, sponsors can evaluate how inclusion or exclusion criteria, visit schedules, and endpoint selection impact enrollment feasibility. This data-driven approach helps sponsors refine trial designs to accelerate enrollment, reduce protocol amendments, and enhance overall study efficiency.
Model the impact of DCT elements — such as remote visits, digital assessments, and at-home data collection — and evaluate their effect on overall protocol complexity, patient burden, and site workload. This helps teams balance innovation with operational feasibility by quantifying trade-offs before implementation.
Intelligent Clinical Trials success stories
Our Intelligent Clinical Trials solution has delivered measurable success for leading pharmaceutical companies. Our AI-enabled analytics have helped sponsors reduce trial complexity, accelerate enrollment, and improve resource allocation. Here are a few standout achievements:
Why choose PwC for clinical trial enhancement?
With over two decades of experience in clinical trial innovation, PwC continues to lead the industry in AI-driven trial design and operational efficiency. Our expertise in protocol digitization and trial design enables sponsors to achieve their study objectives with confidence.
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