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Trial Data collection & Delivery

Capture Cleaner, Higher-Quality Trial Data with Integrated eSource

Streamline clinical trial data capture through eSource workflows that support both Direct Data Capture and automated EHR-to-EDC data transfer across Paradigm Health’s research-ready provider network.

Research teams can capture study data within the EHR or through a standalone application, enabling consistent workflows across sites while reducing manual transcription. Sponsors gain faster access to cleaner trial data with fewer queries and more efficient monitoring.

the challenge

Growing Data Demands Strain Site Capacity and Delay Delivery to Sponsors

Clinical trials generate enormous volumes of clinical data, yet much of that information must still be manually entered, reviewed, and reconciled before sponsors can use it for analysis and regulatory submission.

As protocols grow more complex and data requirements expand, the burden on research teams increases, making it harder for sites to consistently capture study data while sponsors face delayed visibility, higher query volumes, and growing monitoring effort.

Trial Data Delays

Study data often lags behind clinical activity, limiting sponsor visibility into trial performance and delaying key milestones such as interim analyses and database lock.

Rising Costs and Site Burden

When data must be manually entered and verified across sites, sponsors rely on intensive monitoring and query resolution—while research teams face increasing operational burden that limits the number of studies they can effectively support.

the solution

Make Clinical Care the Source of Clean, High-Quality Trial Data

Paradigm Health eSource Casebook enables clinical trial data to be captured and transmitted directly from routine care workflows. Through EHR-integrated eSource capabilities deployed across its research-ready provider network, structured and unstructured clinical data are captured at the point of care, organized within study workflows, and transmitted to sponsor EDC systems.

Research teams work within a consistent set of study workflows across trials, accessing tools directly from the EHR or through a standalone application rather than switching between sponsor-specific systems. This approach simplifies study execution, reduces operational burden of trial data collection, and allows  teams to support more studies while helping sponsors receive cleaner, more complete datasets with fewer queries.

platform capabilities

Embedded Study Workflows and Automated Trial Data Capture

Paradigm Health streamlines study execution by embedding research workflows directly into clinical systems across its provider network. Research teams capture protocol-required data through Direct Data Capture forms used across studies, while existing clinical information can be derived from the EHR and structured within study visit workflows.

Standardized workflows reduce system switching for research teams and enable sponsors to receive more consistent, higher-quality trial data across participating sites.

Seamless Implementation and Configuration

Standards-based EHR integrations and streamlined study configuration enable rapid deployment of research workflows within existing clinical systems.

Automated Transfer & Extraction

Structured clinical data can transfer directly from the EHR while AI pipelines structure relevant trial data from documentation to reduce manual transcription.

Source-Linked Data Verification

Integrated source review tools link study data directly to clinical records, improving traceability and reducing the time required for monitoring and source verification.

Protocol-Guided Data Capture Across Sites

Embedded protocol guidance within Direct Data Capture forms helps research teams capture the right data at the right time, improving consistency across sites and supporting more reliable, audit-ready trial data.

DATA & INTEGRATION INFRASTRUCTURE

Technology Designed for Modern Trial Data Demands

Paradigm Health enables the automated transmission of electronic source data from EHR systems and Direct Data Capture workflows into sponsor data systems through a unified integration layer embedded across its research-ready provider network.

Clinical data can be transferred directly from the EHR, while AI-assisted pipelines structure relevant trial data from documents and other sources using standardized data models that reduce mapping effort.

Direct Data Capture workflows ensure that data not available in the EHR can still be captured within the same system, with each data element linked back to its originating clinical source for field-level traceability.

Standards-Based EHR Integration

FHIR-based integrations connect trial workflows directly to provider EHR systems.

• SMART on FHIR integration
• Compatible with major EHR platforms
• Rapid deployment across sites

Comprehensive Trial Data Coverage

Capture trial-relevant data across multiple systems and documentation sources.

• Structured EHR fields
• Clinical documentation and reports
• Customizable DDC forms

Automated Data Structuring and Mapping

Data is automatically transformed into EDC-aligned CRFs using standardized models.

• Automated mapping to eCRF fields
• Normalization of units and terminology
• Datasets aligned to study database
• Reusable mappings (studies and sites)

Direct EHR-to-EDC Data Transfer

Structured trial data can be transmitted directly to sponsor data systems.

• Automated sponsor EDC transmission
• Reduced data re-entry
• Faster availability of cleaner data

sponsor outcomes
Conduct Trials Alongside Patient Care to Receive Cleaner, Higher-Quality Trial Data

Embedding research workflows into routine clinical care reduces operational burden for participating sites while enabling sponsors to receive cleaner, faster, and more complete trial data. By making studies easier for sites to run, sponsors gain access to more engaged research teams, improved study performance, and more reliable clinical trial data.

Improved Experience and Attractiveness

Reducing data entry burden and simplifying study workflows improves the site experience, making sponsors more competitive when research teams decide which trials to support.

Less Monitoring, Lower Costs

Source-linked verification and structured data capture enable more efficient monitoring workflows, reducing query volume, manual source review, and the need for frequent on-site monitoring visits.

Faster Access to Cleaner Data

Automated data capture and direct EHR-to-EDC transfer reduce delays between clinical activity and sponsor data visibility, enabling earlier oversight, faster interim analyses, and improved operational decision-making.

proof points
Proven Impact Across Technology-Enabled Clinical Trials

Technology-enabled studies supported by Paradigm Health demonstrate measurable improvements in data quality, timeliness, and operational efficiency across clinical trials.

>99% Data Completeness Across Key Study Variables
Across thousands of trial data points in a post-marketing committment, minimal missingness was observed across key baseline and treatment variables.
1.7-Day Median
Data Latency
Structured clinical data reached sponsor systems within days of patient visits, accelerating data visibility and oversight.
<2% Query-to-Datapoint Ratio
High first-pass data accuracy reduced query volume and downstream data cleaning and monitoring effort.
Up to 10× Faster Data Entry
Automated EHR data extraction, eCRF population, and EDC transmission can significantly accelerate study conduct.
View Published Outcomes
modernize your approach to study conduct

Is It Time to Make Your Trials Easier to Run and the Data Easier to Trust?

Paradigm Health helps sponsors reduce site burden while receiving more complete, accurate trial data with less manual effort and monitoring overhead.

Let’s transform how your trials capture and deliver clinical data.

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