Datico® Evidence Lab

Clinical Research Organisations

Validated data collection for studies – efficient, standardized, auditable.

NO STANDARDIZED, GCP-COMPLIANT PLATFORM FOR PHYSIOLOGICAL STUDY DATA.

The problems in CROs

The collection of physiological study data is often carried out across different devices and software solutions – without a uniform structure or synchronization.

The manual transfer and validation of data costs time, carries risks of documentation errors and complicates GCP-compliant auditability.

Studies spanning multiple sites frequently suffer from inconsistencies in data collection, storage and formatting.

Conventional solutions rarely offer flexible, medically validated interfaces to sensors, diagnostic systems and wearables – with the necessary transparency and traceability.

  • Inconsistent data collection across sites and systems.
  • High effort for data validation and auditability.
  • Media discontinuities between collection, documentation and export.
  • Missing synchronization between sensor, diagnostic and participant data.
  • Lack of standardized interfaces and export formats.
  • Complex regulatory requirements for traceability and data sovereignty.

GCP-COMPLIANT DATA COLLECTION, SYNCHRONIZATION AND AUDITABILITY IN STUDY PROJECTS.

The solution

The Datico® LIFE HUB provides a central, structured platform that captures physiological study data in a validated and synchronized manner across sites.

The solution enables GCP-compliant documentation, versioning and export – including complete audit trails and clearly defined role permissions.

Thanks to Datico® Live Control, even complex measurement setups such as wearables, diagnostic systems and chamber environments can be controlled in time sync.

The platform is interoperable, scalable and seamlessly integrable into existing study infrastructures – from participant management to data handover to analysis platforms.

  • Standardized collection of physiological data with audit trail.
  • Time-synchronous control of sensors and measurement environments.
  • Validated exports for analysis, regulatory affairs and archiving.
  • Scalability for multicenter studies and Phases I–IV.
  • Full data sovereignty and GDPR-compliant hosting.
  • Efficient project delivery through modular configurability.

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