Introduction
Discover how ongoing data point locking transforms clinical data management by moving away from traditional « big bang » database locks toward a model of continuous control. This approach significantly enhances data accuracy and operational efficiency in clinical trials, ensuring real-time oversight and faster issue resolution. By implementing continuous locking strategies, organizations can streamline compliance efforts and reduce end-of-study bottlenecks. Read the full article to learn how this methodology drives better trial outcomes and accelerates submission timelines.
What is ongoing data point locking?
Ongoing data point locking is a proactive data management strategy where data is secured—or « frozen »—progressively as it is checked, cleaned, and validated. Instead of waiting for a stressful, single « global lock » at a major milestone, this approach ensures validated data points are immediately secured.
At Excelya, we champion this shift toward continuous data readiness. We believe data should be defendable, traceable, and inspection-ready at any moment, not just at the end of a cycle.
Chez Excelya, les données sont au cœur de notre stratégie de développement clinique
Why Excelya experts prioritize continuous data readiness
Our 100+ global data experts view ongoing data locking as essential for modern clinical trials. By freezing data on a rolling basis, we move away from reactive « cleanup » operations and toward a model of constant quality assurance.
This approach delivers critical advantages:
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Accelerates the database lock:
We remove the bottleneck of large-scale, end-of-study cleaning
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Ensures permanent inspection readiness:
Regulators and sponsors value the ability to audit defendable data at any time.
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Reduces costs and delays:
We minimize the financial and operational risks associated with retrospective data cleaning.
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Improves traceability:
Continuous review aligns with modern integrated workflow methodologies, ensuring superior data integrity.
En pratique : comment geler les données au fil de l’eau ?
« Dans le monde réel, les experts en gestion des données d’Excelya mettent en œuvre le gel continu des données par le biais de plusieurs étapes opérationnelles. Les échecs de sélection sont nettoyés et verrouillés en continu au fur et à mesure de l’examen des dossiers des patients. Les visites des patients sont sécurisées dès que les données externes sont réconciliées et que les données de l’eCRF sont confirmées comme complètes. Pour les centres clôturés, les équipes procèdent au nettoyage et au verrouillage complets des données une fois que tous les patients ont terminé l’étude, garantissant ainsi l’intégrité des données tout en respectant les délais de l’étude. »
How ongoing locking drives flexibility
In the complex landscape of clinical data management, flexibility is not just a luxury it’s a necessity. Here is how ongoing data point locking embodies the agility we value at Excelya:
1. Operational Flexibility
We process data as it flows. Teams shift from a reactive « batch » mode to a continuous, adaptive workflow. This allows us to absorb deviations, adjust workloads, and integrate new data streams without disrupting the project timeline.
2. Handling Complexity and Fragmentation
We manage diverse sources at their own pace. Modern trials generate fragmented data from EDCs, labs, devices, and imaging. Ongoing freezing allows our data managers to lock stable data streams immediately, even if other sources are lagging. This prevents delays caused by data fragmentation.
3. Quality Process Flexibility
We eliminate workload peaks. The traditional « end-of-study » crunch puts immense pressure on teams and increases the risk of error. By smoothing the workload throughout the study, we reduce the need for costly, last-minute cleanups. Our teams remain responsive and focused on quality.
4. Strategic Flexibility
We keep data ready for rapid decisions. In an environment where agility is key, ongoing locking enables faster analyses and supports adaptive study designs. Your data remains consistently ready for statistical review, empowering you to make strategic decisions with confidence.
A modern standard for Data Management
The real ongoing data point locking is central to the transformation of clinical data management. It replaces rigid, sequential processes with a model that is resilient, responsive, and efficient. At Excelya, we see this not just as a process improvement, but as a commitment to excellence. By ensuring immediate data availability and reducing bottlenecks, we help you achieve your ambitious goals and get life-changing
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