CASE STUDY

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

Overview

A long-term regenerative medicine study involving mesenchymal stromal cell therapy required a connected digital workflow for consent, clinical data, patient-reported outcomes, and trial documentation. The study focused on long-term safety, quality-of-life changes, and exploratory laboratory markers related to inflammation, immune function, and aging-related processes.

Because the study involved both treated participants and a non-treated control group, the study team needed a structured way to manage consent records, safety follow-up, laboratory data, quality-of-life assessments, and essential trial documents within one traceable environment.

Clinion deployed EDC, eConsent, ePRO, and eTMF together as one integrated eClinical platform. This helped the study team connect participant onboarding, clinical data capture, patient-reported outcomes, and inspection-ready documentation across the study lifecycle.

Study Snapshot

Industry

Biotech

Client

Regenerative medicine sponsor

Study Type

Interventional

Therapeutic Area

Regenerative Medicine

Study Phase

Phase IV

Study Design

Single-center, decentralized, open-label, non-randomized, long-term safety follow-up and exploratory study

Randomization

Non-randomized

Region

Sweden

Site Count

1 sites

Submission

EU regulatory submission (CTIS), per registry record

Study Duration

Approximately 14 months, per registry record

Products Provided

Clinion EDC, eTMF, eConsent, and ePRO

Challenges

Connecting Consent, Documentation, and Long-Term Outcomes Data for a Decentralized Cell-Therapy Study

The study required long-term safety follow-up, quality-of-life tracking, laboratory data capture, consent management, and regulatory documentation within a single-center regenerative medicine program. The challenge was managing this breadth of data within a non-randomized, open-label design without fragmenting it across separate systems.

Coordinating a Non-Randomized, Two-Arm Follow-Up Design

The study included participants who had previously received MSC treatment and a non-treated control group. The challenge was keeping both groups clearly separated in the data while maintaining consistent capture of safety, laboratory, and outcome information.

Capturing Long-Term Safety and Quality-of-Life Data Over an Extended Follow-Up

The study needed to track adverse events, serious adverse events, laboratory abnormalities, quality-of-life changes, and exploratory biomarker data. Managing these different data types over long-term follow-up required connected clinical and patient-reported data workflows.

Managing Consent, Source Documentation, and Trial Master File Requirements

The study required consent records, clinical data, patient outcomes, and essential trial documents to stay connected and traceable. Managing these separately could create gaps, so the study needed one environment for consent, data capture, and documentation.

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 supported a digital consent process for participants in both the previously treated and control groups, moving consent into a controlled, traceable digital workflow.

This helped support:

Digital consent documentation for both study arms
Consent version control
Traceable, time-stamped consent records
Reduced reliance on manual, paper-based consent tracking

This helped create a consistent starting point for participant enrollment across a study comparing two distinct groups.

Clinion EDC was configured to support protocol-aligned data capture for the study's long-term safety and exploratory endpoints, including adverse event, laboratory, and biomarker data.

This helped support:

Structured capture of adverse event and serious adverse event data
Laboratory and biomarker data capture
Distinct data tracking across the previously treated and control groups
Centralized data review and query management

This helped the study team manage a data-heavy, long-term safety dataset with more consistency than disconnected tracking methods would allow.

Clinion ePRO supported structured capture of the study's patient-reported quality-of-life data, consistent with the trial's use of the EQ-5D-5L measure as a secondary endpoint.

This helped support:

Patient-reported quality-of-life questionnaire capture
Consistent digital administration to participants
Data capture across the study's long-term follow-up window
Alignment between patient-reported and clinical data within the same environment

This helped keep patient-reported outcomes connected to the study's broader safety and biomarker dataset rather than tracked separately.

Clinion eTMF supported centralized management of the study's trial documentation, helping the sponsor stay inspection-ready throughout a decentralized, single-site trial.

This helped support:

Centralized trial master file management for protocol, consent, and regulatory documents
Real-time visibility into document completeness
A traceable, audit-ready documentation trail
Alignment with the trial's regulatory submission requirements

For a decentralized cell-therapy study, this helped reduce the administrative burden of keeping documentation organized and current.

Outcomes

Core Results

Clinion’s integrated eClinical platform helped the study team keep consent, clinical data, patient outcomes, and trial documentation connected in one environment.

Connected Consent-to-Outcome Data

eConsent, EDC, and ePRO helped link consent records, safety data, and quality-of-life responses.

Inspection-Ready Documentation

eTMF centralized essential trial documents with traceability and version control.

Clear Cross-Arm Data Capture

Structured EDC workflows supported consistent data tracking across treated and control groups.

Unlock the Future of Clinical Trials with Clinion.

Cut your trial costs by 35% and accelerate your time-to-market by 30%

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

Study Snapshot

Challenges

Connecting Consent, Documentation, and Long-Term Outcomes Data for a Decentralized Cell-Therapy Study

Coordinating a Non-Randomized, Two-Arm Follow-Up Design

Capturing Long-Term Safety and Quality-of-Life Data Over an Extended Follow-Up

Managing Consent, Source Documentation, and Trial Master File Requirements

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

Clinion eConsent for Digital Participant Consent Management

Structured Long-Term Safety and Outcomes Data Capture

Clinion EDC for Blinded, Multi-Country Data Capture

Clinion eTMF for Trial Documentation and Inspection Readiness

Outcomes

Core Results

Connected Consent-to-Outcome Data

Inspection-Ready Documentation

Clear Cross-Arm Data Capture

Unlock the Future of Clinical Trials with Clinion.

Compliance

Fully Compliant with Global Standards