FDASmart Inc. EDC & CDM Solutions

Transcription

1 FDASmart Inc. EDC & CDM Solutions

2 Our Services Validation of EDC Products as per Client Requirement with compliance with FDA s CFR 21 Part 11 Training on EDC Rave Helps to prepare SOPs and SWIs related with Rave Clinical study build using Rave Configuration of User Interface (UI) and workflow Collecting Protocol Requirement from Sponsor/CRO Outline the DM focus on Protocol review for Study Build Develop clinical database as per CDISC-SDTM standard Understand the regulations as they impact Data Management Annotation of ecrfs Best Practices in ecrf development Assisting on UAT Documentation preparation

3 Rave EDC/ CDM Services We have analyzed the EDC market and prepared the Validation Plan which can match all the requirements from the Sponsor/CRO with the compliance to FDA CFR 21 Part 11. Our special training course from Rave SMEs (Subject Matter Expert) will helps to understand therapeutic development using Rave Our training to end user on Rave EDC as per specific Study requirement will helps to capture all the real time data on time from the Investigator/Site personnel Extensive technology implementation in Rave has improved the access to real time metadata and extract them to submit regulatory authorities. FDASmart will assist the Sponsor/CRO to develop the customization on DB We have completed Medidata Rave validation for Cognizant Technology Services (CTS) and assisted them to prepare the SOPs and SWIs related with processes to compliance with FDA regulations Our service on development offered as same as off-shore cost to manage the clinical trial under budget

4 Why Rave? RAVE platform helps clients manage the business of electronic clinical data management better than any one else. Designed to reduce the latency of information flow, optimize decisionmaking and improve resource allocation and safety, flexible, enterprise-class workflow and web-based technology assists global life sciences and research organizations to accelerate the process of bringing life-enhancing treatments to market. Streamlined collection, verification, consolidation and analysis of clinical research data gives front line investigators, data managers and executives powerful tools to make more precise decisions earlier, reduce costs and drive efficiency. Real time access to clinical data Increased design flexibility of ecrfs Improved clinical data accuracy, completeness and integrity Faster clinical study build in Medidata Rave 21 CFR Part 11 compliance Sophisticated edit checks customized to your needs

5 Clinical Data Configuration FDASmart will assist to configure the below areas: Setting up Marking Groups and Review Groups Role creation and setting up Actions Security Group settings Workflow settings User Interface settings Field Edit Checks settings Deviation settings Clinical View Settings elearning configuration Locale settings DDE settings Amendment Manager settings PDF generator settings

6 Clinical Data Management User / Site Administration FDASmart will assist to provide/manage the below areas: User Account creation Managing user account on behalf of Sponsor/CRO Managing elearning training Instructor-Led Training to the User Managing site assignment Managing Study assignment Create Sites and Site Groups Site Assessment for using Rave product Lab maintenance and setting up Lab Analytes and maintain the Ranges for the Study Setting up Investigator, Cap, Target for the Site

7 ecrfs development FDASmart will assist to develop the below areas: Study settings and create the Draft ecrf development as per CDISC-SDTM standard Setting up Log forms and Record forms Setting up View Restrictions and Entry Restrictions Folder and Visit settings Setting up SAS formats for standard Data Extractions Setting up Data dictionaries, Unit dictionaries, Coding Dictionaries Publish and Push the CRF Version for different environments like Development, Testing, UAT and Production ***FDASmart Rave experts will assist the Sponsor/CRO to get all the development of ecrfs done quickly with some standard best practices and Global library practice.***

8 Edit Checks development FDASmart will assist to develop the below areas: Develop the Data Validation Specification to validate the ecrfs Setting up Standard edit checks Development of Complex edit checks and derivations Development of various edit check actions like Query, Set Calendar, Deviations, Form/Folder setting, Source Data Verification and Review settings Configuration of edit checks for multiple Subject Status and validating multiple Visit structure in the Study Setting up Global Library edit checks to use across all studies for the Sponsor/CRO ***FDASmart Rave experts will assist the Sponsor/CRO to get all the development of edit checks done quickly with some standard best practices and Global library practice.***

9 Custom Function development FDASmart will assist to develop the below areas: Analyze the requirement as per Rave configuration and find the Custom Functions from the provided validations Develop the Custom Function Specification to validate the complex configuration Setting up Unique Subject ID, Folder validation, Functional validation which is not covered under edit checks Development of customized SAE configuration Development of various dynamic links Development of Randomization functionality for the Study Setting up Global Library Custom Functions to use across all studies for the Sponsor/CRO ***FDASmart Rave experts will assist the Sponsor/CRO to get all the development of Custom Functions done quickly with some standard best practices and Global library practice.***

10 On Demand Services FDASmart will assist to On Demand Service for the below areas: Clinical Research and EDC capturing all the live data and needed for periodical analysis. Will assist to get SAS on demand and other data reporting activities Conduct periodical Site Assessment for technical usage and provide periodical training on EDC for Site personnel Preparation of SWIs and SOPs for practicing Rave as per Team structure for Study build activities Setting up Lab Administration which is very complicated in the Clinical Research Using our SmartInspect technology wherever required on Clinical Trial phase ** FDASmart Rave experts will assist the Sponsor/CRO to get all the development of edit checks done quickly with some standard best practices and Global library practice. **

11 Why Us FDASmart Can Assist to Reduce Cost on Clinical Study Development FDASmart is committed to using our experience in this comprehensive suite of industry-leading EDC platforms to meet our client s need. This experience enables us to provide full services and training across any of these systems, regardless of client need. FDASmart performs all Data Management services and hosts data for studies. FDASmart has dedicated EDC experts who develop site and monitor training to ensure the most efficient use of the EDC applications. FDASmart offers US FDA Part 11 training online, Medidata Rave custom training at your facility if desired. Call us for details. ** FDASmart Rave experts will assist the Sponsor/CRO to get all the development cost reduced from the budget and ensures to meet the High Quality of the deliverables **

12 Thank You Contact Details FDASmart assist to Reduce Cost on Study development In USA : In India : 7 Barlow Court, Amawaik, 2/7, Tagore Park Society, New York Nehrunagar Cross Road Rbalani@fdasmart.com Ambawadi, Ahmedabad Office: Gujarat Cell: Dharamvir@fdasmart.com Office: Cell: