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Real World Evidence in Clinical Trials

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Real world data and evidence

At Parexel, we develop strategies and implement approaches to deliver the right evidence across all stages of the product development and post-approval lifecycle. We align with our customers’ clinical and commercial goals to generate evidence by real-world research that:

  • Supports approval and post-marketing regulatory requirements 
  • Drives the differentiation of value against standard of care, comparable products on the market and new entrants 
  • Enables patients to continue access to medicines in a real-world setting 

Our solutions

  • Clinical interventional: Phase IIIb, Pragmatic trials, Post authorization clinical trial commitment, External control arm
  • Extension studies: Rollover and long-term follow up
  • Post-trial access:  Rollover, Early access program, Managed access program, Compassionate use
  • Licence/label expansion 
  • Non-drug interventional

  • Prospective studies: Post-marketing commitments, PASS/PAES, Natural history, survey, COA, surveillance
  • Retrospective studies: Chart review, Natural history, External control, PASS, Burden of disease, HEOR
  • Registries: Product, Disease, Pregnancy
     

  • Protocol design & development/ Medical writing/publication
  • Epidemiology lifecycle strategy
  • Analysis & reporting
  • Integrated evidence planning
  • Regulatory engagement
  • COA sciences: Design, Development, Implementation
     

  • Data insights: Feasibility, Design Optimization, Diversity
  • Secondary data studies: Database landscaping & feasibility, Data use agreements, Data partnerships, Analytics
  • Data engineering: Common data model, RWD/RWE evidence engine
  • Sensors: TA-aligned solutions, E2E delivery models, Digital endpoints
     

CASE STUDY

Assessing long-term safety through a PASS and registry build

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Requirements: Solution: Results:

Requirements:

A pharma company bringing a novel new drug in rare disease to market obtained a post authorisation safety study  (PASS) mandate for surveillance of specified safety signals to ensure ongoing safety of vulnerable patients. Due to the disparate nature of clinical care pathways for these patients being treated at multiple locations and across an array of specialists in a standard-of-care setting, it was critical to deploy an innovative strategy that would allow holistic safety monitoring across multiple representative healthcare interactions.

Solution:

Parexel worked with the customer to map out potential healthcare interactions for these patients and define healthcare settings where medical data would be available to assess safety signals. This included access programs, registries and other healthcare encounters (available across claims, EHR and lab data), utilizing more than 15 data sources. A novel data ingestion and analysis engine was built to ingest disparate data feeds including transformation of all data sources into a common data model for segmentation and analysis.

Results:

Through a creative approach to patient healthcare encounter mapping, acquisition of representative data sources, transformation of data and application of advanced analytical methodologies, Parexel helped our customer to effectivley assess product safety in line with regulatory mandates and allow ongoing access of this novel medicine to a rare and vulnerable patient population. This required a combination of high scientific and technology capabilities along with sophisticated methodological and advanced analytical approaches which is a capability that not all CROs possess.

Trust Parexel’s Real World Research team to deliver 
  • Integrated evidence planning: Parexel’s Real World Research teams are committed to helping you meet the expectations of regulators, payers, physicians and patients and give you the competitive edge – through an integrated evidence strategy.
  • The right data sources: We develop strategies, identify and apply the right data sources that generate Real World Evidence throughout the product lifecycle to help differentiate your products, beginning at the earliest stages of development.
  • Multi-disciplinary experts to align functions: Experts working at each step of the development process look ahead to align functions, anticipate needs, and address challenges proactively across the product lifecycle, including end-to-end evidence generation and communication solutions for Medical Affairs
     

FREQUENTLY ASKED QUESTIONS

RWE describes clinical evidence about the usage and potential benefits or risks of a medical product or practice. RWE is derived from the transformation, analysis, and interpretation of real-world data (RWD) for use in clinical, policy, payer, or other decisions.

RWE drives the differentiation of value against standard of care, comparable products on the market and new entrants. 

Early in the clinical trial planning process, RWE helps identify the appropriate patient populations, and utilizes RWD sources to support inclusion/exclusion criteria.

RWE empowers innovative trials. By combining site-based data with electronic health records and registry data, phase II/III hybrid trials can be conducted. RWE also enhances data from single-arm trials by utilizing external/historic controls. Furthermore, it allows for the creation of external control arms to validate more rigorous comparison to patients in active treatment arms. 

RWE is useful for drug approval because it allows for informed decision making at the right time and assists companies in meeting the expectations of regulators. By utilizing RWD, it enhances the pathway to regulatory approval, from integrated product development planning, through health authority engagement to regulatory submission. And it demonstrates value through evidence-based health economic evaluation and outcomes research.

Our Experts

Mike D’Ambrosio

Senior Vice President and Global Head, Real World Research

Ian Hall

Senior Director, Real-World Evidence and Market Access Solutions

Declan Keogh

Vice President, Process and Quality, Scientific Data Organization

Becky Thompson

Senior Director, Real-World Evidence and Market Access Solutions

Vaneet Nayar

Senior Director, Real-World Evidence (RWE)

Matthew Gordon

Vice President, Real-World Evidence Strategy

David Brown

VP, Epidemiology

Our Experts

Mike D’Ambrosio

Senior Vice President and Global Head, Real World Research

Ian Hall

Senior Director, Real-World Evidence and Market Access Solutions

Declan Keogh

Vice President, Process and Quality, Scientific Data Organization

Becky Thompson

Senior Director, Real-World Evidence and Market Access Solutions

Vaneet Nayar

Senior Director, Real-World Evidence (RWE)

Matthew Gordon

Vice President, Real-World Evidence Strategy

David Brown

VP, Epidemiology

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Frost & Sullivan's 2023 North American Customer Value Leadership Award

Parexel Recognized with Frost & Sullivan's 2023 North American Customer Value Leadership Award for impactful real-world evidence solutions addressing customer needs.

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