Case Study 4: A Full Data Management Solution

Working in a Collaborative Environment The Scenario: A phase II study was being managed by a CRO that had non-dedicated teams, escalating costs, with project timelines slipping on almost every deliverable. RA eClinica Solution: RA eClinica assumed responsibility for entire data management activities consisting of Data Management, Study Build / EDC Development, and Statistics andContinue reading “Case Study 4: A Full Data Management Solution”

Case Study 3: Out-of-Box Solution

The Scenario: The Sponsor required a solution to effectively manage and control users (internal and external). RA eClinica Solution: RA eClinica collaborated with the Sponsor to develop and implement a user management system that involved training tracking record (LMS), user access request, Role-based access control Develop, deploy and host the clinical documentation service and provideContinue reading “Case Study 3: Out-of-Box Solution”

Case Study 2: Supporting the Sponsor with Database Transfer Solution

Assisting the Sponsor with Database Transfer Solution     The Scenario: The Sponsor required a large safety and data management team to assist for a submission deadline requiring the transfer of data to a new safety database for clinical trials and post-marketed products. RA eClinica Solution: RA eClinica responsible for AE/SAE reporting, safety coding, NDAContinue reading “Case Study 2: Supporting the Sponsor with Database Transfer Solution”

Case Study 1: Stand Alone Satellite Office Solution

Integrated Into Sponsor’s Clinical Data Management (CDM) Environment         The Scenario: The Sponsor was in need of a data management team to function in an integrated manner as an extension of the Sponsor’s CDM team. Based on geographic and offices constraints, coupled with the large volume of work, hiring individual contract resourcesContinue reading “Case Study 1: Stand Alone Satellite Office Solution”

Drug Information Update- FDA approves new drug treatment for nausea and vomiting from chemotherapy

Drug Information Update- FDA approves new drug treatment for nausea and vomiting from chemotherapy FDA Division of Drug Information: Know the Moment It Happens The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA. TheContinue reading “Drug Information Update- FDA approves new drug treatment for nausea and vomiting from chemotherapy”

Medical Device Safety and Recalls: Dräger Medical, Evita V500 and Babylog VN500 Ventilators – Faulty Batteries

Medical Device Safety and Recalls: Dräger Medical, Evita V500 and Babylog VN500 Ventilators – Faulty Batteries A recall has been issued for the Dräger Medical, Evita V500 and Babylog VN500 Ventilators – Faulty Batteries . The battery (part of the PS500 Power Supply Unit) that powers the Evita V500 and Babylog VN500 Ventilators does notContinue reading “Medical Device Safety and Recalls: Dräger Medical, Evita V500 and Babylog VN500 Ventilators – Faulty Batteries”

Medical Device Safety and Recalls: Covidien, Puritan Bennett 980 Ventilators – Amount of Air Delivered May Be Lower Than Programmed

Medical Device Safety and Recalls: Covidien, Puritan Bennett 980 Ventilators – Amount of Air Delivered May Be Lower Than Programmed A recall has been issued for Covidien, Puritan Bennett 980 Ventilators – Amount of Air Delivered May Be Lower Than Programmed . When the ventilator is in neonatal Volume Control Plus (VC+) mode with activeContinue reading “Medical Device Safety and Recalls: Covidien, Puritan Bennett 980 Ventilators – Amount of Air Delivered May Be Lower Than Programmed”

Drug Information Update – FDA approves new orphan drug to treat rare autosomal recessive disorder

Drug Information Update – FDA approves new orphan drug to treat rare autosomal recessive disorder FDA Division of Drug Information: Know the Moment It Happens The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.Continue reading “Drug Information Update – FDA approves new orphan drug to treat rare autosomal recessive disorder”

Drug Information Update- Updated Warnings for Safe Preparation and Handling of Treanda (bendamustine HCl) Injection for Intravenous Administration

Drug Information Update- Updated Warnings for Safe Preparation and Handling of Treanda (bendamustine HCl) Injection for Intravenous Administration FDA Division of Drug Information: Know the Moment It Happens The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug productContinue reading “Drug Information Update- Updated Warnings for Safe Preparation and Handling of Treanda (bendamustine HCl) Injection for Intravenous Administration”

Drug Information Update- Updated Warnings for Safe Preparation and Handling of Treanda (bendamustine HCl) Injection for Intravenous Administration

Drug Information Update- Updated Warnings for Safe Preparation and Handling of Treanda (bendamustine HCl) Injection for Intravenous Administration FDA Division of Drug Information: Know the Moment It Happens The Division of Drug Information (DDI) is CDER’s focal point for public inquiries. We serve the public by providing information on human drug products and drug productContinue reading “Drug Information Update- Updated Warnings for Safe Preparation and Handling of Treanda (bendamustine HCl) Injection for Intravenous Administration”