Supporting a Randomized, Double-Blind, Dose-Escalation Trial with Clinion EDC, RTSM, and eConsent
Over View
A clinical-stage regenerative medicine sponsor partnered with Clinion to support a Phase 1/2a clinical study evaluating an investigational intramuscular injection therapy for patients with chronic lower back pain associated with Degenerative Disc Disease.
The study was designed as a double-blinded, randomized, placebo-controlled, dose-escalation trial, requiring careful coordination of subject consent, randomization, treatment allocation, clinical data capture, and study oversight. The public study record describes the trial objective as evaluating the safety, tolerability, and effectiveness of the investigational therapy in patients with chronic lower back pain. To support this complex trial model, Clinion provided an integrated digital trial framework combining EDC, RTSM, and eConsent. This enabled the sponsor and site team to manage consent workflows, randomized treatment allocation, clinical data collection, and trial oversight within a connected technology environment.
Study Snapshot
Industry
Biotech / Regenerative Medicine
Client
Clinical-stage regenerative
medicine sponsor
Study Type
Interventional
Therapeutic Area
Orthopedics
Study Phase
Phase 1/2a
Study Design
Double-blinded, randomized,
placebo-controlled, dose-escalation
Randomization
Double blind
Region
United States
Submission
FDA
Study Duration
28 months as per project input
Products Provided
Clinion EDC, RTSM, and eConsent
Challenges
Navigating a Specialized Regenerative Medicine Trial with Complex Operational Requirements
The sponsor needed to execute a highly controlled interventional study involving a specialized treatment pathway, blinded randomization, and structured clinical data capture. The trial design required a digital setup that could support protocol complexity while keeping site operations manageable.
01
Managing a Double-Blind, Dose-Escalation Study Design
The study involved a randomized, placebo-controlled, dose-escalation model, with subjects assigned across investigational therapy and placebo groups. The public study record describes multiple dose levels and placebo comparison within a blinded design, making randomization control and allocation integrity critical.
02
Coordinating Consent, Randomization, and Data Capture
The study required multiple digital workflows to function together: participant consent, subject enrollment, randomization, and clinical data capture. Managing these workflows through disconnected tools could increase administrative effort, create avoidable delays, and make oversight more difficult.
03
Supporting High-Quality Data Collection for Safety and Effectiveness Evaluation
The objective of the study was to evaluate safety, tolerability, and effectiveness of the investigational therapy in patients with chronic lower back pain. This required structured data capture across protocol-defined visits, treatment-related assessments, and follow-up activities.
Solutions
A Connected Clinion Platform for Consent-Led, Randomized Trial Execution
Clinion deployed an integrated solution combining EDC, RTSM, and eConsent to support the study’s operational and data management requirements. The platform helped streamline key trial workflows while supporting study control, site usability, and oversight.
Outcomes
Core Results
The integrated Clinion platform delivered measurable improvements across data quality, site enablement, and sponsor oversight for this ongoing Phase 1/2a regenerative medicine study.
Data Quality
Structured EDC environment enabled protocol-aligned data capture
Site Enablement
Digital workflows helped simplify consent, randomization, and data entry
Sponsor Oversight
Centralized visibility supported ongoing study monitoring and review
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Compliance
Fully Compliant with Global Standards
