Embedding Verifiable Data Integrity in the Research Lifecycle
Data integrity is the foundation of clinical research. Reliable, accurate, and consistent data is paramount to making informed decisions about drug efficacy, safety, and regulatory compliance. If the data collected during these trials is flawed or compromised, the results could jeopardize patient safety, delay life-saving treatments, and damage the reputation of researchers and organizations alike.
Data integrity in clinical research must be maintained throughout a complex lifecycle where the data is collected from multiple sources, recorded by multiple entities, and potentially stored in multiple places. A Clinical Data Management System (CDMS) is often utilized to collect, validate, and manage clinical trial data. The types of data collected for a clinical trial may include patient demographics (information such as age, sex, race and ethnicity), clinical outcomes (data from laboratory tests, medical exams and patient-reported symptoms), electronic health records (EHRs – detailed patient history and care details), insurance claims data (information on treatment utilization and costs) and direct data capture (DDC – data generated directly by electronic devices for collection). All of this data must be protected from alteration or loss by building verity into the data collection process, associated with the data itself, so fraudulent or human error alterations can be proven in real time throughout the clinical trial process. For regulatory or governance requirements, this verity must be provable now and long after the clinical trial is completed.
For clinical trials, trust demands more than secure access, it requires verifiable evidence.
Walacor embeds that evidence directly into every record. Each file, dataset, or process is secured within a cryptographic envelope that captures origin, authorship, and timestamp. Ordinary data becomes enduring proof that remains with the record throughout its lifecycle.
When proof is part of the clinical trial product, trust becomes quantifiable and reliable.
Walacor establishes a verifiable foundation for clinical trial information integrity at every operational level:
- Authentic records: Policies, reports, and patient data are cryptographically sealed for independent verification.
- Secure collaboration: Clinicians, pharmaceuticals and participating organizations exchange validated information while preserving the integrity of the data.
- Regulatory Compliance: Meet FDA, EMA, and ICH (International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) requirements that data be accurate, complete, and verifiable with cryptographic evidence, eliminating manual attestations.
- AI governance: Training data, models, and outputs are linked to complete provenance for transparent oversight.
- Long-term stewardship: Records retain trustworthiness across changes in systems, vendors, or personnel.
A Unified Standard for Verifiable Trust
Walacor provides institutional credibility by providing the common framework that unifies transparency, compliance, and trust under a single verifiable model, making clinical trial data and process verification continuous and fully automated. Walacor ensures the truth within clinical trial systems remains provable to all stakeholders.
Integrity That Scales
The world depends on data that must be trusted across borders, partners, and decades. Walacor enables organizations to establish trust cryptographically, automatically, and at scale.
When proof is part of the product, credibility compounds, risk diminishes, and every decision is grounded in evidence.
