1. Easy TMF Introduction & Demo for QED Clinical Services
Easy TMF
Electronic Trial Master File
Ensuring documents completeness and compliance for Clinical Trial
Easy TMF Introduction & Demo for QED Clinical Services

2. Challenges in Managing TMF
Access to study related documents : Generally via s, on CD/DVD, or Hard Copies that become difficult to collaborate, manage and control.
Notification : Mostly never automated and have to be initiated on a need basis
Indexing and Searching : Use stovepipe legacy software solutions that are not enterprise-wide, thus being incomplete and incomprehensive.
Document Exports : Very time consuming and requires a lot manual processes if a solution is not present.
Security : Cannot control printing and distribution of documents within or outside the organization. Thereby resulting in pilferage and misuse of sensitive and proprietary.
Audit Trial : User activity and document access information not available or not maintained, there by resulting in queries during internal or agency audits.
System Integration : Integration various software solutions that cater to various business needs almost impossible.

3. WHY? Because we make things EASY
EASY global access, 24/7/365
EASY to show significant cost savings over traditional TMF
EASY standardization and centralization of files
EASY risk mitigation
EASY reporting and audit trails

4. MANAGING TRIAL DOCUMENTS FROM START TO FINISH
Before the trial: Accelerating trial start up
During the trial: Improving trial document visibility
After the trial: Simplifying access and retrieval of trial documents

5. BEFORE THE TRIAL: ACCELERATING TRIAL START UP
Define a logical document structure and create placeholders for required documents
Identifying missing documents and alerting the responsible parties
Simplifying document review and approval via automated workflows
DURING THE TRIAL: IMPROVING TRIAL DOCUMENT VISIBILITY
Enables the trial manager to synchronize documents across investigational sites and provide role-based access and visibility to sponsors, CRO Staff and IRB/IEC members
Track inspection track readiness and trial status
AFTER THE TRIAL: SIMPLIFYING ACCESS AND RETRIEVAL OF TRIAL DOCUMENTS
On completion of trial, makes transferring of the file and responding to subsequent requests for documents much simpler
Rapid document search and retrieval
Automatically set and enforced access and retention policies

6. TMF Paper to Electronic Evolution
Paper TMF Repository
Easy TMF Trial Enabler
Paper based, localized TMFs
Myriad interpretations of requirements
Multiple copy/ master record confusion
Document “graveyard”
No integration with master metadata
Closed/ Locked Environment
Repetitive, error prone process
Manual retention & litigation Holds
Significant scramble for audit/ inspection
Centralized global electronic TMF.
Leverage TMF reference Model.
Sole authoritative artifacts
Active workflows to support study conduct
Robust metadata for search & retrieval
Open Secure Access
Automated workflows support CT process
Coordinated, automated RM processes
Continuous readiness for audit/inspection

7. Easy TMF Overview

8. Value User

9. Easy TMF Overview

10. Key Features
Standards, Quality and Regulatory Compliance, including FDA, QSR and 21CFR Part 11 for Electronic Signature and Traceability
Customizable
Inbuilt Strong Approval Workflows
Role based access
Multiple Projects can run with Team based access
Cloud based Solution accessible through Browser

11. eTMF Demonstration

12. eTMF Index Structure

13. Documents, Status, Approver, Type, Rev]

14. Audit Trail

15. About us
An ingenious solutions provider for all verticals in clinical research.
Managed by experienced industry veterans having expertise in various domains of clinical research.
Team of talented professionals who consistently strive to meet your expectations.
We believe that technology can bring value addition to your business requirements.
e-Solutions is a viable model of delivery in clinical research that increases quality & saves time + cost.

16. Thank you Contact us sudhir.patel@quinaryglobal.com
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