Clinevo Technologies
Aarti Singh is a Senior QA & CSV Consultant specializing in pharmacovigilance (PV), clinical trials, and quality management systems (QMS) at Clinevo Technologies since August 2022. Responsibilities include overseeing central QA activities, reviewing software development lifecycle (SDLC) and computer system validation (CSV) documentation, and ensuring compliance with GAMP5, 21 CFR Part 11, and EU annex regulatory requirements. Aarti is adept at implementing ISO9001:2015 and ISO27000 quality SOPs, managing CSV documentation, and conducting quality training sessions for various teams. Prior experience includes roles as a Subject Matter Expert at Sarjen Systems Pvt. Ltd., Content Writer at Times24 TV, and a Social Media Marketing Intern at DigiGrowHub. Aarti holds a Bachelor of Pharmacy degree from Iimt Group of Colleges.
Clinevo Technologies
Overview: Founded in 2016, we are an IT Services and Software Development Company specialized in developing and implementing robust technology solutions for Life Sciences domain. We help Pharma, Biotech and CROs in reducing their time and cost in Clinical trials by implementing innovative technologies that Data warehousing, Analytics, Collaboration, Automation, and Artificial Intelligence. With our unmatched combination of domain experience & technology expertise, we are committed to delivering the most efficient and practical end-to-end solutions with HIPAA, GXP, CSV, 21 CFR Part 11 and other applicable regulatory guidelines. Our unmatched domain experience and technology to deliver best solutions. Vision: Our vision is to Improve Healthcare by Reducing Time and Cost of Clinical Trials by developing and implementing innovative technologies. Mission: Develop and Implement an integrated platform for Life Sciences Industry that enables data warehousing, Analytics, Collaboration, Automation and AI across the clinical research enterprise. Our Products: Safety: Clinevo OnePharmacovigilance Clinevo Safety (PV Database) MICC Intake Website Intake Signal Detection Safety Analytics Clinical: Clinevo One Clinical Trial Platform Clinical Trial Mamanegement System (CTMS) Electronic Trial Master File (eTMF) Remote Source Data Verification (r-SDV) / Remote Monitoring Electronic Investigator Site Files (eISF) Electronic Data Capture (EDC)/ eCRF Master Data Management (MDM) Meta Data Repository (MDR) Quality: Clinevo One Quality Management System (OneQMS) Document Management System (DMS) Training Management System/ Learning Management (eLearn) Datawarehouse: Clinical Data Warehouse & Automation Console