ACL Digital Life Sciences Elevates Clinical Data Integrity For a Leading Medical Device Firm

Overview

A global medical device leader, with over 5.4 million treatments performed and more than 150,000 patients treated, needed robust statistical and data quality support for their real-world evidence (RWE) studies. Their therapy, indicated for major depressive disorder (MDD) and comorbid anxiety symptoms, required accurate data insights to maintain its clinical and regulatory credibility.

ACL Digital Life Sciences was brought on board to address critical challenges related to data integrity, statistical rigor, and participant compliance, ensuring unbiased and reproducible results that could support ongoing medical claims and regulatory requirements.

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Challenges

Data Quality & Volume

Incomplete, inconsistent, or anomalous entries undermined reliability
Large and diverse data hindered real-time processing and integration
Partial records risked exclusion—wasting valuable data

Statistical Limitations

Being exploratory rather than confirmatory weakened
the strength of hypothesis testing
A narrow analysis scope limited the result’s applicability
to the broader patient population
Data integrity directly affects real-world study value

Analysis Plan & Bias

Tweaking analysis after seeing the data introduced selection bias
Defining objectives post-hoc risked drawing misleading conclusions

Compliance Impact

Participant non-adherence harmed data quality—jeopardizing validity and generalizability

Solution

ACL Digital Life Sciences deployed a comprehensive strategy combining data science, biostatistics, and clinical domain expertise:

Rigorous Data Quality Framework: Implemented stringent data quality checks and cleaning protocols to ensure consistency and completeness.
Minimized Data Exclusion: Ensured complete participant data collection and applied imputation techniques to address missing information.
Bias Mitigation: Established precise, pre-defined analysis requirements and hypotheses before data examination, preventing post-hoc manipulation.
Advanced Statistical Methodology: Utilized fit-for-purpose statistical models aligned with research questions and data characteristics.
Participant Engagement: Developed educational tools and streamlined instructions to improve compliance and data submission accuracy.
Data Governance Implementation: Introduced robust governance policies for ethical data use and ensured metadata standardization.
Complete Process Documentation: Maintained end-to-end transparency by thoroughly documenting all data processing and analysis procedures.
Cross-functional collaboration: Integrated domain experts into all phases—from data collection to interpretation—to ensure clinical relevance.

Outcomes

ACL Digital Life Sciences delivered a measurable impact by enhancing both the validity and utility of the client’s real-world evidence:

Increased Data Integrity: Resulted in more accurate, reproducible, and regulatory-compliant analyses
Reduced Data Loss: Lowered data exclusion rates by addressing completeness and improving participant adherence
Eliminated Analytical Bias: Strengthened the reliability of findings with pre-defined hypotheses and methods
Elevated Study Outcomes: Enabled scientifically sound insights that better represented the target population
Enhanced Regulatory Readiness: Provided well-documented, defensible processes aligned with industry standards and expectations