Document Management

Digital Services

Automation Driven TMF Solutions

Sponsors need to ensure that their Trial Master File (TMF) solution is regulatory compliant and always inspection and submission ready. Syntel’s TMF management solution is designed as a managed service to ensure your clinical trial dossiers are always compliant, consistent and complete.

We manage, modernize and automate global clinical operations processes with robotic process automation, reference models, CRO collaboration and digital solutions to ensure high quality trial documentation so you can bring new life-saving products to market faster.

Our Services 

  • Process Consulting: Define and migrate your TMF repository to the new structure and enable migration to the new structure, ensuring you stay abreast of regulatory and industry changes.
  • TMF Processing: Handle TMF content with assembly line based scanning, indexing and meta-tagging services. By employing automation tools and rigorous process controls, all tasks are strictly monitored and quality checked to eliminate errors, reduce risk, and drive process improvement.
  • Quality Management: Complete data synchronization with automated checks, continuous quality and reporting throughout the trial lifecycle using three workflow levels: 
    • TMF remediation and issues resolution
    • TMF gap analysis and completeness checking
    • TMF reconciliation and remapping
  • Information Security Management: Ensure clinical data security, including physical media, cryptography, tamper proofing, and document administration with strict access controls.
  • Archival, Retention, and Retrieval Services: Manage file rooms, barcoding, receipt, and shipment of documents with advanced metadata tagging, search, and retrieval services.

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, and unique automation approach allow us to support your audit and inspection needs, as well as handle ad hoc volume requests driven by changing business needs.

The Syntel Advantage

  • 20%+ increase in the overall productivity
  • 50% faster turnaround time for request handling
  • Savings of 20-40% year on year, by automating TMF operations
  • SLAs exceeding 98% for a quality controlled and compliant document repository

Real World Evidence

Increasing development costs and demand for personalized therapy are pushing the cost of many drugs out of the reach of people who need them. The Life Sciences industry is also changing the way it demonstrates and communicates the value of medicines both on the market and in development.

Syntel draws on our deep life sciences experience to create integrated IT and knowledge process services that combine real-world research and data from a variety of sources with our SyntBots® automation platform to help efficiently and cost effectively develop the next generation of drugs that will create value for patients.

Our Services 

  • Data Management and Analytics
  • End-to-End document digitization and management
  • Clinical research feasibility consulting
  • Safety and risk management
  • Cost analysis
  • Primary and secondary database study and analytics
  • Administration support
  • Technical support
  • Epidemiologic (observational) studies and research
  • Patient reported outcomes

The Syntel Advantage

  • Automated, semi-automated or manually configured platforms to integrate traditional data sources
  • Reduced per unit cost for effective data
  • An evolved, robust real-world evidence framework to prove product value to payers and providers
  • SyntBots automated machine learning and analytics for a variety of data sources and structures

Clinical IT Services

With diversified work teams working 24*7 across the globe, the complexity and cost of clinical data management has increased significantly. Syntel’s integrated Clinical IT Services help clients achieve accuracy, speed and flexibility to meet their clinical trial needs.

Our Services 

  • IT strategy consulting
  • Clinical application support
  • Clinical trial management systems
  • Electronic Patient Reported Outcome (ePRO) Systems
  • Electronic data capture
  • Clinical drug supplies management systems
  • IVRS and IWRS Implementation
  • Clinical trial process management
  • Clinical end user training

The Syntel Advantage

  • Integrated compliance and regulatory framework for better quality assurance
  • Faster infrastructure and team set-up for quick turnaround
  • Specialized data mapping team, enhancing Clinical Data Management process and delivering improved data models for better analytics and study
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