Easy TMF Introduction & Demo for QED Clinical Services www.quinaryglobal.com Easy TMF Electronic Trial Master File Ensuring documents completeness and compliance for Clinical Trial Easy TMF Introduction & Demo for QED Clinical Services www.steepgraph.com www.quinaryglobal.com

Challenges in Managing TMF Access to study related documents : Generally via Emails, 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.

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

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

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

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

Easy TMF Overview

Value User

Easy TMF Overview

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

eTMF Demonstration

eTMF Index Structure

Documents, Status, Approver, Type, Rev]

Audit Trail

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.

Thank you Contact us sudhir.patel@quinaryglobal.com info@quinaryglobal.com Contact Number +91 9740233593 www.quinaryglobal.com