CASE STUDY

Supporting a Phase IV Regenerative Medicine Study with Clinion’s Integrated Digital Trial Workflows

Overview

A regenerative medicine sponsor running a long-term MSC follow-up study needed one digital workflow to connect participant consent, safety data, laboratory markers, quality-of-life responses, and trial documentation. This was not a simple single-module data capture study; it required four connected Clinion workflows: eConsent for participant onboarding, EDC for clinical and safety data, ePRO for patient-reported outcomes, and eTMF for essential trial documents.

That need for a unified system came from the study’s own scale and structure. It involved 200 participants split across treated and control groups, each generating data across 96 CRF pages, so the EDC had to support a large volume of expected CRF page records covering safety events, laboratory results, adverse events, exploratory outcomes, group-wise data, and follow-up assessments. Alongside that clinical dataset, consent records, quality-of-life questionnaires, and TMF documents all had to stay traceable and tied back to each participant’s record, or the four workflows would simply become four disconnected ones.

Clinion configured the platform around this connected study flow. eConsent supported digital consent forms, version control, and traceable participant signatures. EDC structured the 96-page clinical dataset through study-specific eCRFs, data review, query, and reporting workflows. ePRO captured quality-of-life responses directly from participants, while eTMF centralized document completeness, version history, and inspection-readiness tracking. Together, the setup helped the sponsor reduce manual handoffs and manage consent, clinical data, patient outcomes, and documentation in one controlled environment.

Study Snapshot

Client & Industry

Biotech

Industry

Regenerative medicine sponsor

Client

Study Design

Interventional

Study Type

Regenerative Medicine

Therapeutic Area

Phase IV

Study Phase

Non-randomized

Randomization

Long-term follow-up study comparing previously treated participants with a non-treated control group

Study Design

Scale & Geography

Sweden

Region

1 site

Site Count

Regulatory & Delivery

EU regulatory submission (CTIS), per registry record

Submission

Approximately 14 months (As per registry record)

Study Duration

Products Provided

Challenges

Managing Connected Workflows in a Long-Term Regenerative Medicine Study

This regenerative medicine study used four connected workflows: eConsent, EDC, ePRO, and eTMF. With 200 participants and 96 CRF pages, the sponsor needed to manage consent, safety follow-up, quality-of-life data, and trial documents without creating separate manual workstreams.

Connecting Participant Consent With Study Data

Each participant record had to start with a traceable consent process and continue into clinical data capture and patient-reported outcomes. The challenge was making sure consent status, subject records, and quality-of-life responses stayed connected from onboarding through follow-up.

Designing a 96-Page eCRF Structure for Long-Term Safety Data

Since the study had a large number of participants, the amount of data generated was also massive. The challenge was designing eCRFs that could handle safety events, lab results, adverse events, exploratory markers, and follow-up assessments without making data review difficult.

Keeping Trial Documents Inspection-Ready During Conduct

The study required consent-related files, protocol documents, regulatory records, and essential trial documents to stay complete and current. The challenge was keeping document status, versions, and missing files visible during the study, instead of cleaning them up near closeout.

Solutions

One Unified Environment for Consent, Clinical Data, and Long-Term Outcomes

Clinion deployed an integrated workflow combining eConsent, EDC, ePRO, and eTMF to support the regenerative medicine study. The platform helped the study team connect participant consent, clinical data, quality-of-life outcomes, and trial documentation in one controlled environment.

Clinion eConsent was configured to support study-specific digital consent forms for participant onboarding. Instead of treating consent as a separate paper or PDF process, Clinion used its eConsent workflow to connect consent review, participant signature, investigator approval, and subject enrollment into the downstream study workflow.

Clinion helped by using:

Multimedia-driven consent workflows to make study information easier for participants to understand
ICF version control to keep current and previous consent versions traceable
Time-stamped digital signatures for participant consent records
Investigator review and approval before participant progression
Automated compliance tracking for consent status and version history
Automatic EDC enrollment after consent completion, reducing manual subject setup

This made consent the first connected step in the study workflow, rather than a document that had to be manually tracked and later matched to the clinical record.

Clinion EDC was configured to manage a large eCRF build for 200 participants, with 96 eCRF pages supporting safety events, adverse events, laboratory markers, exploratory outcomes, quality-of-life linkage, and follow-up assessments. At this scale, every participant record carried a substantial number of data points that had to remain complete, structured, and reviewable throughout the study.

Clinion helped by using:

Standardized Global Library components to speed up study-specific eCRF configuration
Reusable form structures for repeated follow-up, safety, lab, and AE data
Custom edit checks and skip logic to reduce missing or inconsistent entries
Bulk configuration options to manage a large eCRF build more efficiently
Data review workflows to detect gaps across safety, lab, AE, and follow-up data
Bulk query or correction workflows for recurring data issues
AI Report Generator capabilities for faster completion, review-status, and follow-up reports
In-platform support through CliniBot to help users resolve product or CRF workflow questions faster

This positioned Clinion EDC as more than a data-entry system. It gave the sponsor a structured way to build, validate, review, query, and report on a large follow-up dataset without relying on scattered forms or manual trackers.

Clinion ePRO was configured as the participant-facing workflow for quality-of-life data capture. Instead of asking participants to complete paper questionnaires or requiring sites to collect and transcribe responses, the Clinion ePRO app gave participants an easy digital interface to complete study questionnaires from their own device.

Clinion helped by using:

Easy-to-use mobile and web access for participant-entered responses
Study-specific quality-of-life questionnaire configuration
Automated reminders to reduce missed questionnaire completion
Real-time field validation to reduce incomplete or incorrect responses
Direct sync with Clinion EDC so ePRO responses stayed linked to the clinical record
Completion visibility for study teams to identify pending or missing responses
Review workflows to follow up on incomplete or inconsistent patient-reported data

This made patient-reported data easier to collect and easier to review. Quality-of-life responses came directly from participants through a guided app workflow, reducing paper handling, site-led transcription, and later reconciliation with the EDC dataset.

Clinion eTMF was configured to keep study documentation current during conduct, not only at closeout. For a regulated regenerative medicine study, the sponsor needed protocol files, consent-related documents, regulatory records, approvals, and study lifecycle documents to remain visible, version-controlled, and inspection-ready.

Clinion helped by using:

A study-specific TMF file plan with document expectations defined upfront
DIA or sponsor-specific TMF structure to match study requirements
Document upload, review, QC, and approval workflows
Version history and document status tracking
Live tracking to flag missing or delayed documents
TMF dashboards for completeness, timeliness, quality, and study compliance
Lock and archive workflows for closeout readiness

This reduced the risk of late-stage TMF cleanup. Instead of discovering missing documents near closeout, the sponsor could track completeness during the study and keep essential records inspection-ready across the lifecycle.

Outcomes

Core Results

Clinion helped the sponsor run a long-term regenerative medicine study with fewer manual handoffs, cleaner follow-up data flow, and stronger inspection readiness.

Consent-to-Capture Continuity

eConsent and EDC connected digital consent with structured study data capture.

Follow-Up Data Control

EDC and ePRO kept safety, lab, AE, and quality-of-life data connected for easier review.

Live Documentation Oversight

eTMF helped track document completeness, versions, and approvals during study conduct.

Unlock the Future of Clinical Trials with Clinion.

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Supporting a Phase IV Regenerative Medicine Study with Clinion’s Integrated Digital Trial Workflows

Study Snapshot

Challenges

Managing Connected Workflows in a Long-Term Regenerative Medicine Study

Connecting Participant Consent With Study Data

Designing a 96-Page eCRF Structure for Long-Term Safety Data

Keeping Trial Documents Inspection-Ready During Conduct

One Unified Environment for Consent, Clinical Data, and Long-Term Outcomes

Guided Digital Consent as the First Step of the Study Workflow

A 96-Page eCRF Built for Long-Term Follow-Up

Direct Quality-of-Life Capture Without Manual Questionnaire Handling

Live TMF Completeness Tracking During Study Conduct

Outcomes

Core Results

Consent-to-Capture Continuity

Follow-Up Data Control

Live Documentation Oversight

Unlock the Future of Clinical Trials with Clinion.

Compliance

Fully Compliant with Global Standards