Episode 6: The ALCOA++ Principles for Data Integrity in Clinical Trials

In this QCast episode, join co-hosts Jullia and Tom as they explore the ALCOA++ Principles for clinical trial data integrity. You'll get clear definitions of the five original ALCOA pillars, the new additions, and learn how to put them into practice across paper, electronic, and hybrid systems.

Key Takeaways

• ALCOA++ is your data backbone, defining ten attributes that keep every record reliable, auditable, and long-lasting.
• The original ALCOA pillars ensure every entry shows who did what, when, and remains clear and true to the source.
•  The ALCOA++ extensions prevent data loss, ensure consistent sequencing, protect records from becoming obsolete, make them available when needed, and add full traceability of all changes. 
• Embedding ALCOA++ cuts down regulatory questions and speeds up inspections by replacing ad-hoc spreadsheets and siloed systems.
• Practical tips for getting started such as mapping your data flow, building source-level checks, synchronising device clocks, training your team, and running mock audits.

🔗 Learn More & Get Support: Visit quanticate.com to explore our biometrics services and discover how we can support your next clinical trial.
📝 Episode Notes & Transcript: Find show notes, resources, and a full transcript at quanticate.com/podcast.
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About Quanticate

Founded in 1994, Quanticate is a biometrics-focused CRO with over 30 years' experience delivering expert clinical and post-marketing data services worldwide. Specialising in the collection, management, standardisation, analysis, and reporting of data, we support pharma and biotech companies globally with high-quality solutions for clinical development. We specialise in:

• Clinical Data Capture & Management
• Biostatistics & Statistical Consultancy
• Statistical Programming & PK/PD Analysis
• Medical Writing & Pharmacovigilance
• Regulatory & Submission Support
• AI & Automation
• Post-Marketing Safety & Real-World Data

Quanticate is committed to delivering expertise and solutions that drive the success of clinical development worldwide.