TMF Management

Digital Services

Introducing Next Generation Digital TMF (dTMF) Services from Syntel

Sponsors need to ensure that their trial dossiers are regulatory compliant and always inspection and submission ready. Now, Syntel has pioneered a new digital approach to manage, modernize and automate global Trial Master File (TMF) operations with process automation, reference models, CRO collaboration and digital solutions to ensure high quality trial documentation.

Syntel’s Digital TMF (dTMF) solution is designed as a managed service to ensure your clinical trial dossiers are always compliant, consistent and complete – enabling you to bring life savings drugs to market faster. Through an intelligent automation approach, we manage, modernize and streamline your global clinical operations and transform core business services to deliver increased productivity, cost and time savings.

Syntel services and solutions meet FDA, MHRA and EMA audit requirements. Our extensive knowledge of ICH E6 guidelines, the DIA reference model and 21 CFR Part 11 requirements allow us to support your audit and inspection needs, and our automated solutions mean we can handle any volume requests driven by your changing business needs.

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Offerings

Process Consulting

  • TMF platform and process assessment
  • Modernization and migration planning 
  • Upgrade to TMF Reference Model v3.0 or OASIS Model
  • TMF restructuring and customization

TMF Processing

  • Assembly line model to scan, index and meta-tag TMF content 
  • Strict monitoring and quality checks to eliminate errors, reduce risk, and drive process improvement

TMF Automation

  • SyntBots® powered automation of core business services 
  • Clinical operations management, modernization and automation
  • Reference models, CRO collaboration and digital solutions

Quality Management

  • TMF remediation and issue resolution
  • TMF gap analysis and completeness checking
  • TMF reconciliation and remapping 
  • Data synchronization with automated checks to eliminate human error

Archival, Retention, & Retrieval Services

  • Manage file rooms, barcoding, receipt, and shipment of documents 
  • Advanced metadata tagging, search, and retrieval services

IT Services

  • L1 & L2 support for eTMF tools
  • eTMF tool testing and analytics 
  • Application maintenance

eTMF Migration

  • Platform, reference model and document migration for eTMF
  • TMF implementation support, including database migration, integration, testing & validation
  • Migration from ICH GCP E6 Guidelines to DIA reference model
  • Mapping CROs and Sponsor TMF structure to the model

 

The Syntel Advantage

 
  • Deep, cross functional experience handling TMF services for global pharmaceutical, medical device and biotech clients
  • Business-ready infrastructure and a dedicated center of excellence (COE) to quickly scale up to support new engagements or volume expansions
  • Extensive suite of tools and accelerators to support TMF operations, including workflow management, quality control,  chain of custody, metadata control, and secure, centralized monitoring portals
  • Product agnostic approach with support for leading eTMF products and platforms
  • Well defined SOPs, business processes, work instructions and QA plans, with the flexibility to adapt our solution to your organization’s maturity and comfort level
  • Defined roadmap to achieve digital TMF driven by quality assurance and compliance
  • Understanding of domain and regulatory requirements including ICH, OASIS, DIA TMF reference model
  • Dedicated team of Quality, Risk and Compliance champions to ensure audit and inspection ready documents

Success Stories

Global Pharma Company Automates TMF Processes with Syntbots®

The client, a top 10 global pharmaceutical company engaged Syntel to provide end-to-end Trial Master File (TMF) services. Later, as the document inventory increased, they began to face issues such as decentralized processes and a high level of inefficient manual work. They asked Syntel to explore how the TMF process could be automated through the SyntBots intelligent automation platform.

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