{"head":{"title":"Pharma and Life Sciences Software Development | OceanLab","description":"Pharma software we build: clinical trial management, eConsent, pharmacovigilance, GMP lab systems and medical rep CRM, with Part 11 controls built in.","canonical":"https://oceanlab.in/software/pharma"},"slug":"pharma","stats":{"builds":5,"countries":5,"systems":5},"featured":[{"meta":{"slug":"kopiec","industry":"pharma","projectType":"Clinical trial operations","country":"pl","tags":["healthcare","enterprise"],"compliances":["EU CTR 536/2014","Polish Clinical Trials Act 2023","ICH E6(R3) GCP","EU GMP Annex 11","21 CFR Part 11","GDPR","DIA TMF Reference Model"],"cover":{"src":"/case-studies/kopiec/01-home.png","width":1440,"height":1000}},"text":{"en":{"title":"Kopiec - Clinical Trial Management System for Sites, Visits and Milestones","description":"Designed and built a clickable clinical trial management system for a Warsaw contract research organisation running phase II and III trials in seven countries: a portfolio dashboard with CTIS notification deadlines, study timelines planned against actual, an 11-step site activation tracker and monitoring visit reports signed with a stated meaning.","category":"Pharma / Clinical Trial Operations","client":"Brzezina Clinical Research"}}},{"meta":{"slug":"cuvette","industry":"pharma","projectType":"Lab inventory (LIMS)","country":"ie","tags":["healthcare","enterprise"],"compliances":["EU GMP (EudraLex Vol. 4)","EU GMP Annex 11","21 CFR Part 211","21 CFR Part 11","ALCOA+ data integrity","FDA OOS guidance","ICH Q1A(R2)","EU GMP Annex 15","USP <1058>","Misuse of Drugs Acts (Ireland)","EU Regulations 273/2004 and 111/2005"],"cover":{"src":"/case-studies/cuvette/01-home.png","width":1440,"height":1000}},"text":{"en":{"title":"Cuvette - 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