Certified clinical trials: digital evidence for trial monitoring and compliance

Certify clinical trial documentation at the source with digital signature and timestamp for GCP and ALCOA+ compliant data.

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La gestione delle emergenze legate a terremoti, alluvioni, frane, incendi e eventi meteo estremi richiede una documentazione rapida, capillare e affidabile dello stato dei luoghi e dei danni subiti. Squadre di intervento, periti, tecnici della protezione civile e operatori di utility producono migliaia di contenuti in condizioni operative difficili, spesso da più postazioni simultanee e con finestre temporali ridotte.

Senza garanzie di integrità, data certa, geolocalizzazione verificabile e catena di custodia, queste evidenze restano esposte a contestazioni sull’autenticità, a duplicazioni e a errori che rallentano la valutazione dei danni, la liquidazione dei sinistri e l’accesso agli indennizzi. L’obbligo assicurativo introdotto dalla Legge 213/2023 e dal DM 18/2025 per la copertura dei danni catastrofali aumenta la necessità di una documentazione probatoria strutturata e conforme.

TrueScreen consente di certificare ogni evidenza raccolta sul campo trasformandola in dato certificato con valore legale: autentico, integro, immodificabile e tracciabile, accelerando perizie, liquidazioni e rendicontazioni nel pieno rispetto degli obblighi normativi.

Industry

Pharmaceutical, clinical research, CRO

Business function

Clinical operations, quality assurance, regulatory affairs

Key process

Clinical trial documentation and monitoring

Certified content

Photos, videos, source documents, monitoring reports, recordings, checklists

Output

Certified documentation and reporting with legal validity

Adoption mode

App / Web / API / SDK

Needs

  • Trial documentation lacking authenticity and integrity guarantees at the source

  • Non-compliance with ALCOA+ principles for data collected without digital certification

  • Risk of inspection findings due to poor traceability of source documents

  • Manual source data verification processes that are slow and error-prone

  • Difficulty proving contemporaneity of data collection during the trial

processo

Solution

TrueScreen consente alle squadre di intervento di certificare foto, video, audio e documenti durante le operazioni di emergenza e post-evento.

Ogni contenuto viene certificato con metadati immodificabili: timestamp, coordinate GPS, identità dell’operatore. Verbali di sopralluogo e perizie vengono firmati digitalmente, creando un fascicolo certificato per ogni evento, area o pratica.

In caso di contestazione su danni o indennizzi, il fascicolo fornisce prove con provenienza e integrità garantite, riducendo tempi di risoluzione e costi legali.

What gets certified

Site documentation

Certified photos and videos of trial site activities, investigational pharmacy, drug storage conditions and visit areas

Source documents

Certified acquisition of CRFs, informed consents, laboratory reports, patient diaries and any original trial document

Monitoring reports

Certified documentation of monitoring visits, on-site verifications, protocol deviations and corrective actions

Drug accountability

Certified records of receipt, dispensing, return and destruction of the investigational product with complete traceability

Expected benefits

  • Trial documentation compliant with ALCOA+ principles from the point of collection

  • Reduced risk of inspection findings due to documentation gaps

  • Complete and automatic audit trail for every piece of trial evidence

  • Simplified source data verification with documents certified at the source

  • Trial Master File with documentation that is intact and verifiable in real time

Partners

Pharmaceutical companies, CROs (Contract Research Organizations), trial sites, ethics committees, regulatory authorities, regulatory consulting firms.

Integrations

eTMF systems (Electronic Trial Master File), EDC platforms (Electronic Data Capture), CTMS systems (Clinical Trial Management System), pharmacovigilance software, quality management systems.

FAQ: certified clinical trials and trial documentation

1) How does clinical trial documentation certification work?
TrueScreen certifies photos, videos and trial documents at the moment of collection by applying a digital signature and timestamp. Each piece of content is recorded with date, time and location metadata, ensuring compliance with ALCOA+ principles.
2) Is TrueScreen certification compliant with ICH E6(R3) GCP?
Yes, certification meets the requirements of ICH E6(R3) guidelines and EU Regulation 536/2014. Every certified data point is attributable, legible, contemporaneous, original and accurate, in full compliance with ALCOA+ principles.
3) What trial documents can I certify?
You can certify any trial documentation: site photos, source documents, CRFs, informed consents, monitoring reports, drug accountability documentation, laboratory reports and patient diaries.
4) How does it support source data verification?
Documents certified with TrueScreen are verifiable at the source without the need for manual comparison with originals. The digital signature and timestamp attest to authenticity and integrity, simplifying the monitor's activities.
5) How does it integrate with eTMF and EDC systems?
Certified reports generated by TrueScreen can be archived directly in the Electronic Trial Master File. The platform integrates with EDC, CTMS and pharmacovigilance systems for centralized document management.
6) How does it reduce the risk of inspection findings?
Certification at the source ensures that every document is intact, traceable and contemporaneous. The automatic audit trail and ALCOA+ compliance significantly reduce documentation non-conformities during regulatory inspections.

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