Today, Truveta announced regulatory and audit capabilities to
support its customers for real-world evidence (RWE) submissions to
the Food and Drug Administration (FDA) and other global regulatory
authority decisions. These regulatory grade capabilities advance
Truveta’s safety, health economics and outcomes research (HEOR),
and clinical trial solutions for life sciences.
Real-world evidence is the clinical evidence regarding the
usage, and benefits and risks, of a medical product derived from
the analysis of real-world data (RWD). The FDA has relied on RWE to
support regulatory decisions to help speed patient access to
innovations that advance public health, noting that RWE can be
leveraged to bring new products to market, evaluate the safety and
effectiveness of existing products for new uses, and assess the
continued performance and safety of products once on the
market.
The FDA suggests the real-life clinical performance of a medical
product may be more clearly demonstrated through RWE and RWD
because a controlled clinical trial often cannot evaluate all
applications of a product in clinical practice across the full
range of potential users.
Truveta offers the most complete, timely, and clean
regulatory-grade electronic health record (EHR) data from more than
100 million patients across 30 US health systems, empowering
researchers to study all diseases, drugs, and devices. Truveta Data
is representative of inpatient and outpatient care from over 900
hospitals and 20,000 clinics. Truveta Data is updated daily for the
most current view of patient care. By providing a complete view of
the patient journey, including clinical notes and medical images,
Truveta enables researchers to accelerate therapy approval and
adoption, and enhance patient care.
Aligned with guidance published by the FDA, Truveta has invested
deeply in establishing rigorous and demonstrable standards of data
quality and provenance, workflow support for regulatory
submissions, and audit-ready processes, procedures, and controls to
support life sciences organizations in meeting the most stringent
requirements of major regulatory bodies.
“The COVID-19 pandemic put the benefits of real-world data on
full display as there was urgent need to accelerate innovations to
advance patient care, which has since led to expanded support for
real-world evidence (RWE) in submissions to major regulatory bodies
across the globe,” said Terry Myerson, CEO and co-founder, Truveta.
“Given the rapidly expanding use of real-world evidence in
regulatory submissions, Truveta has made significant investments to
earn the trust of customers and regulators to use Truveta Data for
regulatory submissions and audits.”
“Truveta’s extensive preparation ensures they have the processes
and procedures in place to successfully deliver regulatory-grade
data to customers. Their commitment, diligence, and preparation are
impressive, and they have demonstrated alignment with FDA current
expectations,” said Deborah Hammond, regulatory and quality
consultant, formerly with the FDA for over 40 years.
Truveta Data endorsed as research-ready for regulatory
submissions
Key areas of investment into Truveta Data include a
state-of-the-art data quality management system (QMS), third-party
system audits by regulatory experts, and industry-leading security
and privacy certifications.
- Truveta’s quality
management system ensures data integrity. In accordance with
regulatory guidance, Truveta has implemented a robust quality
management system to ensure the highest standards of data integrity
and continuous improvement. Data quality metrics include
representativeness, completeness, cleanliness, and timeliness. Each
of these must be met from the point of ingestion through multiple
stages in the data pipeline. Truveta has full transparency into the
provenance of each data point given its unique relationship with
health system members, who provide the data for Truveta
Data.
Truveta has designed hundreds of product and process
improvements to exceed FDA regulatory expectations, implemented
more than 70 process and procedure controls aligned with FDA
guidance, and created more than 30 standard operating procedures
focused on regulatory requirements. Each component within Truveta
has a standard operating procedure in which risks are identified
and purpose-built processes and software controls are written.
Continuous monitoring and evidence logging ensure the system
complies with these standards and that Truveta customers can prove
the integrity of the data and documentation included in their
regulatory submission.
- Truveta Language
Model is accurate, transparent, and accountable. Truveta
Language Model (TLM) is a large-language AI model used to clean
billions of daily EHR data for scientifically rigorous research.
TLM’s healthcare expertise is trained on Truveta Data, the largest
collection of complete medical records representing the full
diversity of the United States. TLM cleans concepts from
unstructured clinical notes. Each clinical concept extracted from
notes is accompanied by documentation of the concept definition,
modeling methods, and the precision/recall of TLM’s extraction.
This documentation is designed to be shared as part of
regulatory-grade evidence submission.
- Truveta Data is
audit ready. All data and documentation are stored for the
duration required by the FDA and are accessible by the researcher
if or when an audit occurs. With secure storage and versioning of
all data, metadata, analytic code, and evidence, researchers can
readily retrieve evidence for regulatory audits upon request. Logs
proving system integrity during artifact creation with direct
linkages to the artifacts themselves are stored and can also be
shared.
- Type 2 SOC 2
attestation and ISO 27001, 27701, 27018 certifications demonstrate
Truveta’s relentless commitment to security and privacy. To
protect Truveta Data, Truveta developed one of the most advanced
data security and privacy systems in the healthcare industry.
Truveta’s systems protect data through every stage of this process
and have been validated to meet the most rigorous standards for
privacy and security. Truveta has earned Type 2 SOC 2 examination
and ISO 27001 certification, with ISO 27018 and 27701 extensions,
with additional certifications underway. These certifications serve
as external validation that Truveta’s controls, protocols and
processes align with rigorous standards for both security and
privacy.
New regulatory submission capabilities in Truveta
Studio
In addition to investments in Truveta Data, Truveta delivered
new advancements to Truveta Studio, its analytics platform, to
support customers at each stage of the regulatory process,
including artifact creation, regulatory submission, and any
regulatory audits. Customers can:
- Classify a study as
intended for regulatory submission upon creation. This makes the
study identifiable as a regulatory artifact and unlocks features
for evidence generation, regulatory exports, and default data
retention policies.
- Classify a
population snapshot as intended for regulatory submission. This
defaults the snapshot to an indefinite retention policy and
administrator privileges are required for deletion. Additional
evidence is generated to link the snapshot, to be used as source
data for a submission, to the system controls validating its
integrity at the point of generation.
- Classify a notebook
analysis as intended for regulatory submission upon finalization.
This also generates additional evidence linking the finalized
analysis to the controls demonstrating its integrating.
- All regulatory
artifacts can be placed into a read-only and verifiable export
supporting regulatory submission.
- All logged evidence
proving the integrity of system processes involved in artifact
creation is stored internally and readily available. It can be
provided easily to an auditor upon request, ensuring that Truveta
customers are well supported during a regulatory audit.
New regulatory professional services available from
Truveta
In addition to embracing a growing partner ecosystem, Truveta
now also provides regulatory professional services, including
support for post-marketing commitments and/or requirements
(PMC/PMR) and post-authorization safety and/or efficacy studies
(PASS/PAES). Organizations can use Truveta to monitor safety and
effectiveness, especially in populations not typically represented
in a clinical trial setting, as well as evaluate real-world
clinical effectiveness, adherence, and dosing.
Truveta also now supports label expansion efforts, such as
understanding safety and effectiveness in broader populations
compared to the approved label, evaluating how real-world dosage
changes may impact safety and efficacy compared to the approved
dosage, and exploring comparative effectiveness and safety against
standard of care or other comparators.
Supporting these services is the Truveta Partner and dedicated
Regulatory Success team, whose collective experience and
credentials include over 170 publications, nearly 11,000 citations,
over 200 conference presentations and posters, and dozens of
regulatory projects across numerous state, federal, and
international governments and agencies.
About Truveta
Truveta is a growing collective of health systems in the US with
a mission of Saving Lives with Data. Truveta delivers the most
complete, clean, and timely regulatory-grade EHR data for
scientifically rigorous research. Truveta is trusted by more than
60 leading life science, government, health system, and academic
and research organizations to accelerate adoption of new therapies,
improve clinical trials, and enhance patient care.
Truveta membership includes Providence, Advocate
Health, Trinity Health, Tenet Healthcare, Northwell
Health, AdventHealth, Baptist Health of Northeast
Florida, Baylor Scott & White Health, Bon Secours
Mercy Health, CommonSpirit Health, Hawaii Pacific
Health, HealthPartners, Henry Ford Health
System, HonorHealth, Inova, Lehigh Valley Health
Network, MedStar Health, Memorial Hermann Health
System, MetroHealth, Novant Health, Ochsner
Health, Premier Health, Saint Luke’s Health
System, Sanford Health, Sentara Healthcare, Texas
Health Resources, TriHealth, UnityPoint
Health, Virtua Health, and WellSpan Health.
- Truveta is a growing collective of health systems in the US
with a mission of Saving Lives with Data.
Ellie Lampton
Truveta
2064092192
ellief@truveta.com