Biotechnology and CRO

Situación:

A CRO manages 15 simultaneous clinical studies with data distributed across multiple systems (EDC, CTMS, IWRS). Project managers take 2-3 days to consolidate information for reports to sponsors, missing opportunities for early intervention against deviations.

Solución:

Layer 1 (Digitalization): Automatic aggregation of data from multiple clinical systems (EDC, CTMS, IWRS) into a single source of truth, without touching existing systems. Layer 2 (Monitoring): Unified dashboard that visualizes recruitment vs. targets, protocol deviations, open queries, and site status per study with alerts when critical metrics fall below thresholds.

Impacto:

70% reduction in reporting time to sponsors (from 2-3 days to 2-3 hours). Detection of recruitment problems 4-6 weeks earlier, enabling proactive adjustments. 25% improvement in patient retention rate thanks to early visibility of sites with problems.

Situación:

A biotech company with 40 active sites in 8 countries needs to identify which have better performance (recruitment speed, data quality, protocol adherence) for future studies. Manual analysis is subjective and takes weeks of work.

Solución:

Layer 1 (Digitalization): Consolidation of objective KPIs from clinical centers across multiple sources (EDC, CTMS, quality systems). Layer 2 (Monitoring): Automatic scoring and benchmarking dashboard that compares sites by patients recruited/month, query resolution time, protocol deviation rate, and % of visits completed on time. Visual ranking by country, site type, and study phase.

Impacto:

Site selection for new studies based on objective data instead of perception. 30% reduction in recruitment timelines by prioritizing top performers. Identification of 5 sites with systematic underperformance, enabling specific training or exclusion.

Situación:

A CRO must ensure compliance with GCP, FDA 21 CFR Part 11, and GDPR across all its studies. Internal audits detect gaps only retrospectively, generating findings in regulatory inspections. Lack of continuous visibility into essential documentation and training status.

Solución:

Layer 1 (Digitalization): Integration of eTMF, LMS (Learning Management), and QMS into a single compliance data source. Layer 2 (Monitoring): Real-time tracking of missing or expired essential documents, expired training, pending protocol deviations, and open CAPAs. Layer 3 (Response): Automatic proactive alerts to responsible parties 15-30 days before expirations, triggering corrective action flows before they become findings.

Impacto:

Zero major findings in the last 3 FDA/EMA inspections. 85% reduction in missing essential documents in TMF. 100% of staff with current training thanks to proactive alerts. CAPA closure time reduced by 50% through better tracking.

Situación:

A biotech company detects protocol deviations (visit windows out of range, omitted procedures) only when the monitor visits the site or during data review, weeks after the event. This generates complex queries, data quality problems, and risk of invalidating patients.

Solución:

Layer 1 (Digitalization): Predictive analysis of visit windows through data integration from EDC and IWRS that identifies deviation risks before they occur. Layer 2 (Monitoring): Dashboard that visualizes windows about to expire, pending mandatory procedures, and unverified out-of-range values. Layer 3 (Response): Automatic early alert to the CRA and site 7-10 days before the window closes, enabling rescheduling or corrective intervention.

Impacto:

60% reduction in protocol deviations related to visit windows. Issue detection 15-20 days earlier vs. retrospective, enabling timely corrective actions. 40% decrease in patients excluded due to major deviations. Improved data quality as perceived by sponsors.