Standardizing Safety and Performance Data Across a 10-Site Cochlear Implant Study with Clinion EDC
Overview
Cochlear implant studies depend on clear comparison between a patient’s hearing performance before implantation and their progress after device activation. A multinational technology and engineering services company’s medical device division partnered with Clinion to support this pivotal medical device study, which needed to capture performance, effectiveness, and safety outcomes across both adult and pediatric participants.
The study evaluated a cochlear implant system in patients with severe to profound bilateral sensorineural hearing loss. It was designed as a prospective, multicenter, non-randomized, non-blinded, single-arm pivotal study across India, with follow-up timelines differing for adults and children. Adult subjects were followed for 4 months per subject, while children were followed for 6 months per subject, per the registry record.
Clinion EDC is used as the central data capture platform across the study’s 10 participating sites. It helps the study team capture preoperative hearing data, post-activation performance outcomes, safety events, and follow-up records in a consistent structure across the national site network.
Study Snapshot
Industry
Medical Device
Client
Medical device sponsor
Study Type
Interventional
Therapeutic Area
Otolaryngology
Study Phase
Phase III
Study Design
Prospective, multicenter, single-arm pivotal study
Randomization
Not applicable
Region
India
Site Count
10 sites
Submission
Public registry study
Study Duration
11 months, per registry record
Products Provided
Challenges
Keeping Hearing Performance Data Connected from Baseline to Follow-Up
The study needed each patient’s preoperative hearing status and post-activation performance data to stay connected in one record. The challenge was keeping this comparison clear across adult and pediatric patients, different follow-up timelines, and 10 participating sites.
01
Connecting Baseline and Post-Activation Hearing Outcomes
The study evaluated improvement in hearing and speech performance after device activation. The challenge was making sure baseline and follow-up data stayed aligned, so each patient’s progress could be reviewed clearly.
02
Managing Different Follow-Up Timelines for Adults and Children
Adults and children had different follow-up durations after activation, per the registry record. The study team needed a data capture setup that could support both pathways without creating confusion across visit schedules or missing required assessments.
03
Standardizing Safety Data Across 10 Implant Sites
The study involved medical, surgical, and device-related adverse event reporting across a 10-site national network. The sponsor needed consistent safety documentation across all sites, especially because cochlear implantation involves both procedure-related and device-related follow-up.
Solutions
Connecting Cochlear Implant Study Data Through Clinion EDC
Clinion EDC is configured to support the study’s adult and pediatric assessment pathways within one controlled data workflow. The platform helps the sponsor manage eligibility data, hearing performance records, safety information, and review workflows across the 10-site implant study.
Outcomes
Core Results
Clinion EDC is helping the sponsor manage a national pivotal cochlear implant study with clearer structure across patient pathways, follow-up visits, and site review.
Patient Pathway Clarity
Structured eCRFs help keep adult and pediatric study data organized within one trial.
Performance Data Continuity
Visit-wise workflows help connect post-activation hearing performance, effectiveness, and safety data.
Site Consistency
A shared EDC environment helps 10 sites capture study data in the same structure.
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Compliance
Fully Compliant with Global Standards
