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Features and Capabilities

A single point of access for users with a set of modules integrated in one platform.

Site Start-Up

Trial Master File

E-Archive

Remote Quality Control

Investigation Site File

Site Start-Up

Reduce site activation timelines

Orchestrated Site Start-Up speeds site activation and keeps sites engaged throughout the entire trial.
Every study stakeholder knows what tasks to complete by when
Automated workflows reduce manual follow-ups and ensure no critical step is missed.

Operational Efficiency

Reduce burden on study teams and give them complete oversight
Eliminate paper/email-based manual processes
Reduce manual labor in distributing, processing and signing site start up documents.

Sponsor Visibility

Get real-time oversight of site start-up progress
Create, manage and access site regulatory binders in one place
Easily manage all site activation activities from a single view — search, filter, and attach documents, track progress, and related communications in one centralised system

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Investigator Site File (ISF)

Operational Excellence

Sites get an advanced eISF solution with the following features: e-signatures, automated tasks, advanced workflows, digital delegation log, version controls, access controls, inspection readiness.
Reduce administrative site burden
Decrease document cycle times

Workflow automation

Sites create workflow standardization across their procedures
‍Centralize all documents in one platform
‍Gain real-time visibility into document status across all studies

Data Integrity & Compliance

Perform continouos auditing to avoid last minute stress for insepction preparation
Increase data quality and transparency. Identify risks with real time monitoring and dashboards
Compliant Electronic Signatures

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Remote Quality Control (RQC)

Continuous Quality Oversight

Enables centralized, real-time review of doumnts. Hold monitoring visits from anywhere
Identifies quality gaps early to avoid inspection issues
Supports proactive compliance across sites

Collaborative Review & Querying

Leave comments and query, validate easily tasks and documents
Guide sites on required next steps in real time
Automated alerts for pending tasks. Automatically route documents from a site’s eISF to a sponsor’s eTMF

Role-Based Review & Audit Trails

Assign reviewer roles by function, region, or study
Maintain complete, time-stamped audit trails
Ensure transparency and compliance at every step

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Trial Master File (eTMF)

Sponsor-Centric Customization

Fully mapped to the DIA TMF Reference Model Configurable workflows and metadata fields
Adaptable templates to match sponsor SOPs
Scalable setup for studies of all sizes

Real-Time Oversight & QC

Real-time visibility into TMF completeness and compliance
Built-in quality checks and audit trails
Enhances inspection readiness and transparency

Customizable Interoperable

Fully customizable roles and permissions
Supports multi-sponsor, multi-site collaboration
Seamless integration with sites eISF

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E-Archive

Secure Long-Term Archiving

Compliant with GxP and FDA 21 CFR Part 11
Guaranteed long-term readability and accessibility
Robust backup and disaster recovery processes

Regulatory-Ready & Validated

Aligned with the DIA TMF Reference Model
Supports audit trails and inspection readiness
Fully validated to meet global regulatory standards

Seamless Integration & Retrieval

Easily integrates with TMF/ISF systems. Export documents in compliant formats anytime
Quick document retrieval with smart search
Role-based access and version control

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Thank you for your interest in our product. We will get back to you soon and communicate the next steps.

Best Regards, The Allyfe Team.

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Get an informative, quick demo.

Features and Capabilities

Site Start-Up

Reduce site activation timelines

Operational Efficiency

Sponsor Visibility

Investigator Site File (ISF)

Operational Excellence

Workflow automation

Data Integrity & Compliance

Remote Quality Control (RQC)

Continuous Quality Oversight

Collaborative Review & Querying

Role-Based Review & Audit Trails

Trial Master File (eTMF)

Sponsor-Centric Customization

Real-Time Oversight & QC

Customizable Interoperable

E-Archive

Secure Long-Term Archiving

Regulatory-Ready & Validated

Seamless Integration & Retrieval

Request Demo

Contact Allyfe