Registry Studies
Delivering data-driven, actionable insights with fit for purpose real-world registry solutions
Consistent and reliable data are critical when using real-world data (RWD) for decision-making in product development. With the increased use and acceptance of RWD by stakeholders such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), registry data have become incredibly valuable due to the breadth and depth of information they collect.
Disease registries collect patient-level data on individuals with a specific disease or medical condition, providing statistics on patient experiences, health data and medical care. Used alone or in conjunction with other datasets, registry data offer insights into treatment patterns and outcomes, including clinician-reported outcomes (CROs) and patient-reported outcomes (PROs), to inform development and treatment decisions and best practices.
Product registries are essential to provide evidence of a therapy’s quality, safety, and efficacy. Robust product and patient registries can help researchers expand their understanding of diseases, patient outcomes, and treatment effectiveness and safety over longer periods of time in a real-world setting.
Get answers to your research questions — from foundational to the most complex — with our innovative and effective registry solutions.
Leveraging registry data at every stage of development
Registries offer valuable insights for both clinical and observational research, supporting everything from pipeline assessment to clinical trial design to safety and effectiveness in real-world use. Documented, longitudinal patient data captured in registries offer an anonymized, panoramic view of the specific disease being studied and the patients affected. Including registry study designs in your development strategy has the potential to reduce costs, strengthen evidence of product value and improve health outcomes, offering real-world evidence applicable to a variety of research needs, such as:
- Demonstrate natural history, unmet need and disease burden
- Assess comparative effectiveness and comparative safety
- Determine product effectiveness
- Monitor long-term safety and meet real-world regulatory requirements
- Describe real-world care patterns
- Examine quality of life (QOL) over time
- Identify biomarkers associated with clinical outcomes
- Improve representation and monitoring of underrepresented populations
Delivering registry designs to meet your needs
Our highly experienced team provides a variety of registry study solutions to meet your needs and goals. We tailor our study design and collection strategies to your research need for a customized approach that delivers the robust, reliable data that meet your requirements.
Independent registries
Our innovative, proprietary independent PPD™ CorEvitas™ Clinical Registries are disease-based, multi-drug registries that collect highly complete, regulatory-grade longitudinal data to efficiently address a multitude of RWE needs.
This model captures broad safety, effectiveness, treatment pattern, natural history and quality of life data directly from clinicians and patients.
Key characteristics
- Cost and data sharing
- Renewable licenses to data
- Complete, high-quality, regulatory-grade data using validated CRO and PRO measures
- Ongoing site and patient involvement for continuous and expanding longitudinal data collection
Unique value
- Critical contextualization of your drug’s positioning relative to standard of care
- Active assessments of critical clinical endpoints and safety events in combination with PROs
- Flexible infrastructure with ability to add data collection or nested studies as evidence needs evolve
- Long-term ongoing registry growth
- Lower cost per patient over time
Use cases
- Bridge randomized controlled trial (RCT) and RWE with pivotal Phase III endpoints collected within the registry
- Meet FDA and EMA requirements with post-marketing safety studies (PASS)
- Assess comparative effectiveness and comparative safety
- Demonstrate natural history, unmet need and disease burden
- Support health economic and outcomes research (HEOR) and medical affairs activities
Single sponsor registries
Our single sponsor registries use innovative technologies and patient-centric methodologies to create a customized collection of data for a specific product.
Our approach can reduce burden, improve retention, enhance data quality and streamline the longitudinal collection of data.
Key characteristics
- Data collection based on real-world exposure to a specific product
- Sponsor has full control of scope, protocol and engagement with physicians and ownership of all data
- High-quality data that meet stringent regulatory standards
- One-time registry with a fixed duration to fulfill specific study needs
Unique value
- Customizable, fit-for-purpose registry design and data collection analysis
- Flexible program planning
- Patient-centric protocols designed to reduce burden and optimize retention
Use cases
- Assess product effectiveness
- Monitor long-term safety
- Describe real-world care patterns
- Meet regulatory agency requirements for long-term follow-up
Pregnancy exposure registries
Prospective in nature, pregnancy and lactation exposure registries actively engage pregnant and lactating persons and their health care providers (HCPs) to capture data throughout pregnancy and the first year of the infant’s life. With the guidance and expertise of our Pregnancy and Lactation Center of Excellence, we provide a variety of innovative pregnancy and lactation study models to efficiently satisfy regulatory post-marketing requirements.
Implementing diverse methodologies
One methodology isn’t always the best solution when considering study design. Research goals are often best achieved by applying multiple data sources, including secondary (existing) and primary data collection. Through our integrated approach, we provide our clients with extensive methodological knowledge and experience. By considering diverse data designs, including registries, our RWE team assesses your research needs and goals and provides a data design approach that optimizes evidence generation and overall success.
Learn more about the full potential of clinical registriesDelivering operational excellence
A great study design is only the first step in delivering great results. The success of any study relies on top quality execution. Our highly qualified operational team brings implementation experience and solutions to elevate your study and achieve your goals. With an extensive global footprint, we provide established and proven resources and processes for study efficiency from startup to completion, including:
- A global network of high-enrolling, established sites
- Technology platforms to streamline workflows and align to client preferences
- Decentralized study solutions
- Flexible data collection with less site and investigator burden
- Right-fit staffing models to meet study goals
- Experienced and tenured team members dedicated to delivery excellence
Exceed your study goals with a partner focused on assessing your specific research needs, providing strategic recommendations and delivering quality results.
Providing global experience
Our global team of scientific and operational experts, including clinicians, epidemiologists, data analysts, biostatisticians and data technologists, brings specialized knowledge to our integrated approach. Drive your product development forward with a uniquely positioned partner that can integrate registry data with precision focus and proven expertise.
Years of experience designing and operationalizing global, real-world studies
Active proprietary registries with long-term follow-up data collection
Single sponsor registry studies in the past five years
Multi-country studies using secondary use of data
PASS studies using linked registry and secondary data
Prospective pregnancy registries
The addition of registry data to real-world studies opens up new opportunities for deeper data collection and stronger evidence generation. Explore the use of registries in your development strategy to improve efficiencies, expand insights and build stronger evidence to move your product forward.