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.

Request a demo

Clinical trials require rigorous, traceable documentation at every stage. EU Regulation 536/2014 and ICH E6(R3) guidelines set demanding standards for the collection, preservation and verifiability of clinical data, in line with ALCOA+ principles.

Site activity photographs, source documents, adverse event records and investigational medicinal product accountability checks often lack guarantees of authenticity and certain time-stamping. TrueScreen certifies every digital evidence at the moment of collection with a digital signature and timestamp, ensuring integrity, traceability and regulatory compliance from the source.

TrueScreen enables sponsors, CROs and trial sites to certify trial documentation directly at the point of collection. Every photo, video, source document and monitoring report is digitally signed and timestamped, ensuring compliance with the ALCOA+ principles required by GCP.

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 enables sponsors, CROs and clinical trial sites to certify photos, videos, source documents and monitoring reports directly during trial operations.

Every piece of content is certified with immutable metadata: timestamp, GPS coordinates and operator identity. Source data verification reports and monitoring visit records are digitally signed, creating a certified dossier for each trial, site or regulatory submission.

In the event of a regulatory inspection or audit, the certified dossier provides evidence with guaranteed provenance and integrity, reducing the risk of findings and simplifying source data verification across clinical sites.

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.

Related use cases

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.

Request a free demo

Talk to our experts and discover TrueScreen for certified clinical trial documentation.

Fill in the form to request a free demo.

By submitting, you agree to our Privacy Policy.

Inviando, accetti la nostra Privacy Policy.

Thank you!

Grazie!

We received your message and will get back to you shortly.

Abbiamo ricevuto il tuo messaggio e ti ricontatteremo al piu' presto.