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I have 9+ years experience in testing profile. I am keen learner and recently I have done validation for eCaselink domain as per WHO Guideline 21 part 11 CFR for pharmaceutical.I worked as quality control associate and my roles and respnsibil...Show More
eCaseLinkTM 10.0 (eSource, EDC)http://dsg-us.com/index.html
eCaseLinkTM 10.0 (eSource, EDC)
eCaseLink (EDC),eSource is a web based software application that provides clinical data management for the clinical trial industry (Pharmaceutical, Life Sciences and medical device industries) over the Internet. It is unique user-friendly presentation layer of web based eCRFs, appear within your browser window that are identical to the traditional paper CRFs, is a product feature solely offered by DSG that makes the transition from paper to virtual data collection easier, time saving and cost effective. An Electronic Data Capture (EDC) system is a computerized system designed for the collection of trial data in a electronic format for use in human clinical trials.Show More Show Less
SkillsManual Testing Team Foundation Server (TFS) Spira Team SQL Testing Framework Integration Testing Jira
ToolsTFS Spira Team Postman
eCaseLinkTM 8.0 (EDC)http://dsg-us.com
eCaseLinkTM 8.0 (EDC)
eCaseLink (EDC) is a web based software application that provides clinical data management for the clinical trial industry (Pharmaceutical, Life Sciences and medical device industries) over the Internet. It is unique user-friendly presentation layer of web based eCRFs, appear within your browser window that are identical to the traditional paper CRFs, is a product feature solely offered by DSG that makes the transition from paper to virtual data collection easier, time saving and cost effective. An Electronic Data Capture (EDC) system is a computerized system designed for the collection of trial data in a electronic format for use in human clinical trials.
Enables sponsors and CROs to streamline study setup and efficiently manage the execution of complex clinical trials, eCaseLink EDC consistently delivers clean data, quick and efficient work flow, accelerated reporting and analysis.Show More Show Less
DSG’s eCaseLinkTM Safety system streamlines the safety recording, reporting process, data entry on Serious Adverse Events (SAEs), and can store documents associated with the safety event that facilitate the generation and tracking of queries.
eCaseLink Safety enables medical monitors to record the SAE information received allowing manual data entry into forms, as well as completed specific fields mapped from the eCaseLink EDC system. Key events, such as dates and the eCRF status are all easily tracked and managed. It has a configurable workflow with a multi-level approval process that integrates with other regulatory and management systems. A user can view a single case or span across multiple protocols and easily generate tracking reports.Show More Show Less
Clinical Trial Management System (CTMS)http://dsg-us.com/dsg-product-ctms.html
Clinical Trial Management System (CTMS)
Clinical Trial Management System application. Accessible anywhere in the world via an Internet connection, ClinDirect provides a centralized database for sharing clinical trial information. Information about the sponsor, protocol, and investigators, and CRA monitoring visit reports are also available online, in real-time. Role-based security provides various levels of access control. An e-Signature function facilitates the electronic workflow of the visit monitoring forms. Investigator visit monitoring reports entered into a relational database, making their content available to any user anywhere in the world with an Internet connection and the proper security credentials. Reports can be generated in real-time, showing the planned-versus-actual status of monitoring activities and exposing protocol deviation and adverse event reporting issues in a timely manner. DSG’s unique approach validates that the online visit monitoring form questionnaire is filled out completely; that comments exist for questions with negative answers. The online form is then routed via electronic workflow using an e-Signature design. E-mail notifications are available, and all actions write to an Audit Trail. DSG’s CTMS solution makes the content of the monitoring visit forms available online, in real-time for review by members of the project team. Advanced reporting functions provide easy access to metrics, workflow events, action items, documents collected, and protocol deviations. DSG’s CTMS is configurable. The configuration process begins with a discussion of the desired access control levels and electronic workflow of the monitoring visit reports. The online monitoring visit report form questionnaires are customized to the needs of the particular sponsor/study. The Investigator information is then loaded into the product’s relational database and users are defined to the system. Customized reporting is available.Show More Show Less
eCaseLink Mobile Apphttp://dsg-us.com/dsg-product-epro.html
eCaseLink Mobile App
This is HIV clinical Trail survey application which is run on window 8.0 tablet. End users first register households through web application and then sync the data from server to device. One/more participant would be register under one household by filling questionnaires form. The purpose of this app is collects, manages, and analyzes clinical data of multiple participants by filling the questionnaire and then sync back to device to server for analyzing data through various reports.
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