{"head":{"title":"How to Build a Clinical Trial Management System | OceanLab","description":"How to build a clinical trial system: sites, visits, eConsent, safety reporting, trial master file, Part 11 controls, integrations and cost drivers.","canonical":"https://oceanlab.in/build/clinical-trials"},"slug":"clinical-trials","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":"tomoshibi","industry":"pharma","projectType":"eConsent & recruitment","country":"jp","tags":["healthcare","enterprise"],"compliances":["PMD Act","J-GCP","MHLW eConsent guidance","APPI","Japanese ER/ES guideline","21 CFR Part 11","Act on Electronic Signatures"],"cover":{"src":"/case-studies/tomoshibi/01-home.png","width":1440,"height":1000}},"text":{"en":{"title":"Tomoshibi - Trial Recruitment and eConsent Platform for a Japanese SMO","description":"Designed and built a clickable recruitment and eConsent platform for a Japanese site management organisation: a pre-screen leads pipeline with contact SLAs, a consent status view against the current IRB-approved version, and a participant consent record with every signature, quiz result and question a monitor needs to see.","category":"Pharma & Life Sciences / eConsent & Recruitment","client":"Mizunagi Clinical Partners"}}},{"meta":{"slug":"umlindi","industry":"pharma","projectType":"Pharmacovigilance","country":"za","tags":["healthcare","enterprise"],"compliances":["Medicines Act 101 of 1965","SAHPRA PV guideline","ICH E2A","ICH E2B(R3)","ICH E2C(R2)","ICH E2D","POPIA","ECT Act"],"cover":{"src":"/case-studies/umlindi/01-home.png","width":1440,"height":1000}},"text":{"en":{"title":"Umlindi - Pharmacovigilance Safety Database with Regulator Clocks","description":"Designed and built a clickable safety database for a South African generic medicines company: one intake inbox for calls, emails, web forms, rep and partner reports, case processing with MedDRA coding and WHO-UMC causality, medical review sign-off, and a submission clock that counts every SAHPRA and partner deadline from Day 0.","category":"Pharma & Life Sciences / Pharmacovigilance","client":"Suurveld Pharmaceuticals"}}}]}