Data Collection and Management

Integrative Approaches for Comprehensive Insights

At Kernel,

Our Data Collection and Management service is designed to handle the full spectrum of research scenarios—from controlled clinical trials to real-world observational studies and large-scale public health initiatives. By uniting robust methodologies, advanced technology platforms, and global regulatory compliance, we ensure that data from multiple sources seamlessly converge into a credible, actionable dataset.

Multimodal Data Collection

Clinical Trial CRFs (Paper & Electronic)

We develop customized Case Report Forms (CRFs) aligned with ICH E6 GCP to capture high-fidelity data in interventional studies. These can be implemented as paper forms or electronic CRFs (eCRFs) within secure Electronic Data Capture (EDC) systems.

Electronic Health Records (EHR) & Claims Data

For real-world evidence (RWE) projects, our team securely extracts information from EHR systems and insurance databases. We utilize standardized data-extraction protocols, ensuring consistent variables and precise patient mapping across clinical settings.

Registries & Observational Cohorts

We design and manage patient registries, prospective or retrospective, to gather longitudinal data. This approach is invaluable for tracking real-world usage patterns, safety signals, and long-term outcomes in multiple therapeutic areas.

Patient-Reported Outcomes (ePRO) & Surveys

In support of patient-centered research, we incorporate electronic PRO tools and digital surveys. These methods facilitate direct participant input and can be tailored for bolstering engagement and data completeness.

Wearables & Mobile Health Technologies

Our capabilities extend to integrating data streams from consumer devices (e.g., fitness trackers, smartphone apps) and specialized medical wearables. By leveraging these continuous data feeds, we capture real-time metrics, steps taken, glucose levels and heart rates, that enrich both clinical and public health research.

Community-Based & Public Health Surveys

For epidemiological investigations and community health assessments, Kernel employs culturally sensitive surveys, structured interviews, and field-based observational methods. These strategies help illuminate health behaviors, resource utilization, and barriers to care in large populations.

Advanced Data Management Workflows

Quality Control & Validation

We implement double-data entry, automated discrepancy resolution, and real-time validation checks to maintain accuracy across all data sources—be they CRFs, EHR feeds, or wearable devices.

Harmonization & Standardization

By adopting internationally recognized coding systems (e.g., MedDRA, WHO-Drug), we harmonize disparate data elements, laying the groundwork for credible statistical analyses.

Security & Compliance

All data transfers and storage processes adhere to HIPAA, GDPR, and local regulations where applicable. Our EDC platforms and database servers feature encryption, role-based access, and strict audit trails to protect patient confidentiality.

Centralized Data Repositories

We create secure, centralized repositories enabling researchers, clinicians, and sponsors to access cohesive dashboards. This single source of truth minimizes duplication and promotes timely, data-driven decisions.

Regulatory Alignment & Ethical Oversight

Global Standards

Every step—from CRF design to final database lock—is structured around ICH E6 GCP, FDA 21 CFR Part 11 (for electronic records), and local IRB requirements.

Transparent Audit Trails

Our systems log each entry, modification, and user interaction. This ensures inspection readiness and fortifies trust among regulators and sponsors.

Benefits of Kernel’s Integrative Approach

·Comprehensive Coverage

We accommodate diverse data sources—clinical, observational, digital—to build a holistic perspective on treatment efficacy, safety, and public health outcomes.

Scalable & Adaptive

Our infrastructure scales seamlessly for single-site trials, multi-center studies, large observational cohorts, or nationwide surveillance programs.

Streamlined Analysis

High-quality, harmonized data expedite subsequent statistical evaluations, fueling faster progress toward regulatory submissions, publications, or policy recommendations.

By integrating multiple data-collection methods, from CRFs to registry data, EHRs, and wearables, Kernel’s Data Collection and Management service supports rigorous, participant-centered research across all phases of clinical and public health investigations. Contact us to explore how our methods can optimize your project’s data integrity and accelerate meaningful outcomes.

Your Data, Our Commitment

With Kernel CRO’s Data Collection and Management service, you can focus on your research while we handle the complexities of data. Let us help you turn raw data into actionable insights that drive your study forward.