Clinical Trials
Standardising Study Execution, Site Coordination & Compliance with goPLIMS
- Clinical trials suffer from protoco! deviations, documentation gaps, and fragmented communication across CROs, sponsors, and sites
- Teams rely on email, spreadsheets, EDC add-ons, and disconnected systems, slowing study execution
- Site readiness, monitoring, and compliance data are scattered, creating audit risk
- No unified execution platform linking study teams, vendors, and clinical sites
- Manual tracking of site readiness, monitoring actions, deviations, and study tasks
- Slow communication cycles between CROS, sponsors, and sites
- Fragmented documentation (protocols, amendments, logs, approvals, training records)
- Limited visibility into study progress, risk items, and compliance status
- Unified study execution platform connecting sponsors, CROs, and clinical site
- Structured workflows for deviations, RFls, decisions, and change control
- Structured workflows for deviations, RFI’s, decisions, and change control
- Real-time dashboards for study progress, site performance, and risk tracking
ActionR: Replace excel sheets to collaborate with cross-functional teams: meeting management
RFI-M: Structured RFl workflows for site queries and clarifications
DecisionM: Decision logging with rationale, approvals and audit trial
ChangeM / DeviateM: Protocol change control & deviation management
FormM: Create and manage field execution of digital forms/records online
EDocM + E-SignM: Controlled documents, SOPs, protocols, amendments, and digital approvals
TrackR: Live dashboards for study progress, site performance, and compliance status
PunchM: Manage snags / defects online for all site-level findings
Metric
Protocol Deviation Close-Out Time
Site Readiness Accuracy
Documentation Traceability
Decision Cycle Time
Target KPI
30-50% faster
95% real-time visibility
100% audit-ready
Reduced by 20-30%