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GoResearch.live

Electronic data capture for clinical trials, observational studies, and patient registries with real-time validation and FDA 21 CFR Part 11 compliance.

Solution by 2KMM
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Overview

GoResearch™.live is a fully validated Electronic Data Capture (EDC) platform developed by 2KMM, a contract research organization (CRO) with over 20 years of experience supporting clinical trials and observational studies. The platform is designed for pharmaceutical, biotechnology, medical device, and healthcare research organizations that require flexible, compliant, and technology-driven data collection solutions for modern clinical research.

2KMM operates as a full-service CRO, offering expertise across clinical operations, data management, biostatistics, medical writing, and safety monitoring. Its services and tools are built in accordance with GCP, FDA 21 CFR Part 11, and GDPR requirements, and the organization holds ISO 9001 and ISO/IEC 27001 certifications. To date, 2KMM has supported 59 studies across 14 countries, involving over 52,000 patients and more than 3,500 investigators.

GoResearch™.live — EDC Platform Capabilities

  • No-code setup of customizable electronic Case Report Forms (eCRFs)
  • Real-time data validation to support data integrity throughout the study
  • Full compliance with FDA 21 CFR Part 11, GCP, and GDPR
  • Supports traditional, hybrid, and decentralized study models
  • Secure API for integration with external systems, enabling electronic source data (eSource) and Real World Data (RWD) collection
  • Real-time oversight tools to monitor study progress and data quality

Companion Tools

  • GoResearch™ App: A mobile application for patients or clinicians supporting data collection via electronic questionnaires (ePRO, eCOA) and connected mHealth devices. Provides instant data transfer to the study database and supports study alerts and reminders. Available for Android and iOS.
  • GoInsights™: A platform for building custom data collection or presentation tools, including ePRO, eCOA, eIC, and investigator training modules. Supports various data entry options and multimedia content. Hardware-agnostic and fully responsive; can operate standalone or integrated with GoResearch™.

Electronic Data Collection Services

  • eCRF design and development
  • Data management plans and data validation plans
  • Query management and medical coding
  • Support for ePRO, eCOA, and eIC data collection

Rescue Studies and Statistical & Data Quality Audits

  • Development of effective strategies for rescue studies
  • Protocol assumptions verification
  • Study population size validation
  • Statistical analysis plan reviews
  • Statistical calculations validation
  • Data quality audits

Clinical Operations

  • Project management
  • Study documentation development and management
  • Site and patient recruitment
  • Study monitoring
  • Site management

Biostatistics

  • Protocol development support
  • Statistical analysis plans
  • Statistical design and analysis
  • Final and interim study reports
  • Randomization and blinding

Medical Writing

  • Protocols and investigator brochures
  • Narratives and case narratives
  • Clinical study reports (CSR)
  • Manuscripts and abstracts

Safety Monitoring and Pharmacovigilance

  • Adverse events monitoring
  • Safety database maintenance
  • SAE, SUSAR, and USADE reporting
  • Safety management plans and safety guidelines
  • Periodic safety reports

GoResearch™.live and the broader 2KMM CRO service portfolio are built to integrate with external data sources including mobile devices, medical devices, and medical system databases. The platform has been used in academic and postgraduate settings, including workshops at the Jagiellonian University, and 2KMM has participated in EU-funded research under the Horizon 2020 programme. The organization is also a technological partner of the Polish Association for Good Clinical Practice (GCPpl).

Meta

Domain
Clinical Trial Management
Subdomain
Electronic Data Capture (EDC)
Software type(s)
Workflow Automation
Deployment type(s)
Cloud / SaaS
Industry vertical(s)
Academic / ResearchBiotechCROMedical DevicesPharma
Development stage(s)
ClinicalPost-Market & RWE
Target user(s)
Research ScientistQA / Regulatory AffairsClinical / Diagnostic Professional
Compliance standard(s)
21 CFR Part 11GDPRGxPHIPAAISO 27001