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Welcome to Binteca Clinical SiteOS

Binteca Clinical SiteOS is Binteca (Pty) Ltd.'s Pan-African Clinical Site Operating System & Trial Management Platform. This instance is deployed exclusively for EzCRO Inc. (Johannesburg, South Africa) — connecting academic hub hospitals to community health center spoke clinics across South Africa and beyond.

ℹ️
This is a UAT (User Acceptance Testing) environment. You are working in a safe, fully functional staging environment at https://ezcro.mpondoland.com. All data entered here is for testing purposes. No live patient data is ever entered in UAT.

Who is this guide for?

  • Clinical Research Coordinators (CRCs) — managing participant visits, eSource capture, and stipend disbursals.
  • Principal Investigators (PIs) & Sub-Investigators — reviewing site performance, regulatory milestones, and trial status.
  • Sponsor / CRO Representatives — running feasibility assessments, reviewing retention KPIs, and monitoring regulatory readiness.
  • Regulatory Affairs Staff — tracking SAHPRA milestones, ALCOA+ audit readiness, and eTMF compliance.
  • Site Managers / SMO Leads — overseeing the full hub-spoke network and sentinel surveillance readiness.

What you can do in EzSiteOS

🌐
Explore Clinical Site Network
Browse hub hospitals and spoke community clinics across South Africa, Kenya, and Uganda.
Run Feasibility Assessments
Generate real-time protocol feasibility scorecards for sponsor RFPs in under 60 seconds.
📋
Log Patient Encounters
Capture GCP-compliant eSource records with cryptographic ALCOA+ audit stamps, even offline.
👥
Manage Participant Retention
Send multilingual protocol nudges and trigger instant mobile money stipend disbursals.
🚨
Sentinel Surveillance
Monitor syndromic outbreak signals across all sentinel nodes and activate emergency protocols.
🛡️
Regulatory & eTMF Audit
Track SAHPRA milestones, ICH-GCP compliance, ALCOA+ data integrity, and Africa clinical trial advantage metrics.
💡
Quick Start Tip Use the sidebar on the left (or the ☰ button on mobile) to jump to any module's guide at any time. Each section is independent — you don't need to read from top to bottom.
Platform Architecture

Platform Overview

EzSiteOS is built on a Hub & Spoke architecture — the same model used by leading global CROs — adapted for the realities of the African healthcare landscape: intermittent connectivity, community-centered care, and a uniquely diverse patient population.

Hub & Spoke Architecture

The EzCRO network connects two types of clinical sites:

  • Academic Hubs — Tertiary academic hospital research centers (e.g., Charlotte Maxeke, Groote Schuur, King Edward VIII). These carry full cold-chain infrastructure, -80°C ultra-low biobanking, GCP-certified Principal Investigators, and NHREC-accredited ethics committees.
  • Primary Care Spokes — Community Health Centers embedded in high-density townships (Soweto, Khayelitsha, Umlazi). They are where participants actually live and receive primary care — delivering the patient catchment that drives EzCRO's superior retention rates.
  • Pan-African Expansion Nodes — Partner sites in East Africa (Nairobi, Entebbe) for multi-country trial capability and vaccine/pathogen-X coverage.

Key Performance Metrics

The performance strip at the top of every page shows live network metrics:

  • Hub & Spoke Nodes — Total active sites in the network.
  • Cohort Retention (85–96% target) — The most critical KPI; EzCRO's differentiator versus global competitors.
  • Ethics Turnaround (≤ 6 weeks target) — Average time from protocol submission to SAHPRA / NHREC approval.
  • Pandemic Surge Activation — Standing readiness to activate trials within 72 hours of an outbreak signal.
  • Major GCP Violations — Always zero. Non-negotiable.

Technology Stack

  • Offline-first design — The eSource eCRF module queues records locally and syncs when connectivity is restored, critical for spoke clinics with intermittent internet access.
  • 21 CFR Part 11 / ALCOA+ compliance — All encounter records are cryptographically hashed (SHA-256) with a tamper-evident audit trail.
  • WhatsApp / SMS gateway — Automated multilingual visit reminders in isiZulu, isiXhosa, Sesotho, Swahili, and English.
  • Ozow / Mobile Money integration — Instant transport stipend disbursals triggered at nurse check-in, eliminating cash handling risks on-site.
🏥
Regulatory Frameworks Supported SAHPRA (South African Health Products Regulatory Authority) · ICH-GCP E6(R2) & E6(R3) · FDA 21 CFR Part 11 · African Medicines Agency (AMA) · NHREC Ethics Accreditation
Getting Started

Getting Started

Follow these steps to orient yourself in EzSiteOS for the first time. The entire workflow is browser-based — no software installation is required.

Step-by-Step: Your First Session

  1. Open the platform — Navigate to https://ezcro.mpondoland.com in any modern browser (Chrome, Firefox, Safari, Edge). The platform works fully on mobile phones and tablets.
  2. Check the connection badge — In the top-right navigation bar, the green "Online (Sync Active)" badge confirms the platform is live and your eSource queue will sync in real time. If you see "Offline — Data Queued", your records are being saved locally and will sync automatically when connectivity returns.
  3. Read the performance strip — The teal metrics bar below the header gives you an instant snapshot of the entire EzCRO network: total sites, retention rate, ethics turnaround, surge readiness, and GCP violation count.
  4. Navigate the module tabs — Six modules are accessible from the tab bar beneath the performance strip. Tap or click any tab to switch modules. On mobile, the tab bar scrolls horizontally — swipe to reveal all six tabs.
  5. Explore the Hub-Spoke Network first — The Hub-Spoke Network tab (🌐) is your starting point. Click any site card to inspect its full capability profile: investigators, cold-chain, biobanking, retention rate, and linked spokes.
  6. Run a Feasibility Assessment — Switch to the Automated Feasibility tab (⚡), set your protocol parameters, and click Generate Feasibility Scorecard. This takes under 5 seconds and produces a site allocation recommendation.
  7. Log a test encounter — In the Offline eSource / eCRF tab (📋), fill in the participant encounter form and click Log Encounter & Cryptographic ALCOA+ Audit Stamp. The encounter appears immediately in the audit trail with a SHA-256 hash.

Interface Orientation

  • Top Navigation Bar — Brand logo, connection status, environment badge (UAT), and regulatory compliance badge (SAHPRA / 21 CFR Part 11).
  • Performance Strip — Live key performance indicators for the entire EzCRO network.
  • Module Tabs — Six functional modules. Swipe horizontally on mobile.
  • Workspace Content — The main panel below the tabs, specific to each active module.
  • Footer — Platform metadata: estate control plane, UAT host, and port.
⚠️
Do not enter real patient data in UAT. This environment uses simulated data for training and testing purposes. Real participant identifiers, real health data, and real stipend transactions must only ever be entered in a validated production environment with a Data Management Agreement in place.

Simulating Offline Mode

Click the Simulate Offline Mode button in the top-right navigation to test the offline-first eSource behavior. In offline mode:

  • The connection badge changes to "Offline — Data Queued".
  • Encounter records are queued locally in the browser.
  • When you click Simulate Offline Mode again to restore connection, queued records sync automatically to the audit trail.
  • This demonstrates how spoke clinic coordinators can capture data in a rural clinic with no internet and have it sync when they regain connectivity.
Module 1

🌐 Hub-Spoke Network Explorer

The Network Explorer gives you a real-time view of every clinical site in the EzCRO network — from Johannesburg's academic hubs to community health centers in Khayelitsha and partner nodes in Nairobi.

How to Use This Module

  1. Filter by site type — Use the chip buttons at the top of the site list to filter by: All Sites, Academic Hubs (3), Primary Care Spokes (3), or Pan-African Nodes (2).
  2. Select a site — Click any site card in the left column. The right panel (Site Detail) updates immediately with the site's full capability profile.
  3. Review the site detail — The detail panel shows: site type and status, province/country, number of GCP investigators and study coordinators, cold-chain infrastructure, biobank capacity, average ethics turnaround, active trial slots, therapeutic areas, cohort retention rate, and connected spoke clinics.

Understanding Site Types

Academic Hub Sites

  • Full cold-chain: 2-8°C, -20°C, and -80°C ultra-low freezer capability.
  • NHREC-accredited in-house ethics committee — enables fast-track protocol approvals (avg. 4.8–5.5 weeks).
  • Principal Investigators trained in ICH-GCP E6(R2).
  • Biobank capacity: 28,000–50,000 aliquots on-site.

Primary Care Spoke Nodes

  • High patient catchment (180,000–550,000 patients in the surrounding community).
  • Transit biobanking (3,800–5,000 aliquots) — samples collected and transported to hub on cold chain.
  • Embedded in the community — driving EzCRO's superior 89.8–96.4% retention rates (vs. global average of ~65%).

Pan-African Expansion Nodes

  • Status: Pre-Qualified — undergoing site qualification and regulatory pathway alignment.
  • Specialized in emerging pathogen panels, zoonotic disease, and vaccine trial readiness.
💡
Sponsor / CRO Tip When evaluating EzCRO for your protocol, select Academic Hub sites first for Phase I–II trials requiring ultra-low cold chain and ethics infrastructure. Layer in spoke sites for Phase III enrollment velocity in high-catchment communities.
Module 2

⚡ Automated Feasibility Engine

The Feasibility Engine enables sponsors and CRO development partners to generate a real-time protocol matching scorecard in under 60 seconds — without sending an RFP email and waiting weeks for a response.

How to Run a Feasibility Assessment

  1. Select Therapeutic Indication — Choose the trial's disease area from the dropdown: Infectious Disease (HIV, TB, Emerging Pathogens), Metabolic, Cardiovascular, Oncology, Respiratory, Women's Health, or Pandemic Preparedness / Vaccine.
  2. Set Trial Phase — Choose Phase I through Phase IV. Phase I and II assessments are scored against hub site capacity. Phase III and IV benefit from spoke site enrollment velocity.
  3. Enter Sample Size — Input the number of participants required (20–5,000). The engine calculates whether EzCRO's network can enroll this cohort within your timeline.
  4. Set Target Enrolment Timeline (Months) — How many months do you have to achieve full enrollment? The engine compares this against projected enrolment velocity across matched sites.
  5. Cold Chain Requirement — Check the box if your protocol requires -80°C ultra-low biobanking and cold-chain logistics. Hub sites all have this; spoke sites have 2-8°C and -20°C only.
  6. Click "Generate Feasibility Scorecard" — The evaluation result appears in the right panel within seconds.

Reading the Feasibility Output

  • Feasibility Score (out of 100) — Scores ≥ 85 are graded "HIGHLY FEASIBLE — RECOMMENDED FOR IMMEDIATE ACTIVATION". Scores below 85 are graded "FEASIBLE WITH EXTENDED SPOKE RECRUITMENT".
  • Matched Sites — The list of sites whose therapeutic areas match your indication, with projected individual recruitment shares.
  • Projected Enrolment Timeline — The estimated months to achieve full enrollment at current site capacity.
  • Projected Retention Rate — EzCRO's network-average projected retention for your cohort.
  • Regulatory Path — The recommended ethics and regulatory pathway (SAHPRA Fast-Track or standard CTA).
  • Feasibility Reference ID — A unique ID (e.g., FS-A3B2C1D0) you can reference in sponsor communications.
📊
What drives the score? The score is calculated from: indication-matched site count, GCP investigator capacity relative to sample size, alignment of projected enrolment velocity with your timeline, and cold-chain readiness. Sites are never fabricated — the engine draws directly from the live site database.
Module 3

📋 Offline eSource / eCRF

The eSource module is the clinical data capture engine for spoke clinic coordinators working in the field. It is designed to work fully offline and produce cryptographically verified 21 CFR Part 11 / ALCOA+ compliant audit records.

Who uses this module?

Primarily: Study Coordinators and GCP-Certified Nurses at spoke clinic nodes who need to capture participant visit data regardless of internet connectivity.

How to Log a Patient Encounter

  1. Select the Clinical Trial — Choose the active trial from the dropdown (e.g., EZ-2026-HIV04 Phase IIb Antiretroviral).
  2. Select the Clinic Node — Choose the spoke clinic where the visit is occurring (Soweto Chiawelo, Khayelitsha CHC, or Umlazi Gateway).
  3. Enter Participant Code — Enter the participant's anonymized study code (e.g., SOW-1049). Never enter a participant's real name or government ID here.
  4. Select Visit Protocol Milestone — Choose the visit type: Screening & Informed Consent, Day 1 First Dose, Week 4 Safety Follow-Up, Week 12 Primary Endpoint, or Week 24 Final Cohort Visit.
  5. Record Vitals — Enter the four mandatory vitals: Blood Pressure (format: 120/80), Heart Rate (bpm), Temperature (°C), and Weight (kg). All values are validated for physiological plausibility.
  6. Enter IP Lot Number — Record the Investigational Product lot number and kit identifier from the dispensed supply.
  7. Enter Transport Stipend Amount (ZAR) — Record the stipend amount per the approved ethics stipend schedule for this site and visit type.
  8. Sign off as GCP Coordinator — Enter your name and GCP certification number (e.g., Sister N. Khumalo, RN (GCP-SA-4412)). This forms the attributable signature per ALCOA+.
  9. Click "Log Encounter & Cryptographic ALCOA+ Audit Stamp" — The record is immediately added to the audit feed on the right with a SHA-256 hash, timestamp, and sync status.

Understanding the Audit Trail

Each logged encounter displays in the Verified eSource Log (Audit Trail) panel with:

  • Encounter ID — Unique identifier (e.g., ENC-2026-8803).
  • SHA-256 Hash — A cryptographic fingerprint of the complete record. Any subsequent modification would produce a different hash, making tampering detectable — satisfying FDA 21 CFR Part 11 §11.10(e).
  • Sync Status"Online Queue" means live sync; "Offline Queue" means stored locally pending sync.
  • Offline Capture indicator — Flagged if the record was originally captured without internet connectivity.
⚠️
ALCOA+ Requirement: Contemporaneous Entry Encounter data must be entered at the time of the participant visit — not from paper notes transcribed hours or days later. Post-hoc entries must be logged as amendments with an explicit reason-for-change in a production system.

Offline Mode Behavior

When the platform is in offline mode (or the device loses connectivity mid-session):

  • The encounter form remains fully functional — you can still capture all fields.
  • Records are stored in the browser's local queue.
  • The Offline Queue badge on the encounter card updates with the count of unsynced records.
  • When internet connectivity is restored, queued records sync automatically — no manual intervention required.
Module 4

👥 Retention & Stipends

EzCRO's 85–96% cohort retention rate is its most powerful clinical advantage. This module manages the two key tools that make that retention possible: automated multilingual protocol visit nudges and instant mobile money transport stipend disbursals.

Automated Multilingual Nudges

Participants in EzCRO trials receive automated visit reminders through WhatsApp and SMS, in their home language, days before their scheduled visit.

  1. Select the Target Language — Choose from: isiZulu (KwaZulu-Natal / Gauteng), isiXhosa (Eastern Cape / Western Cape), Sesotho (Free State / Gauteng), Swahili (East Africa Nodes), or English. The message preview updates instantly.
  2. Review the Message Template — The preview box shows the exact message participants will receive, including the participant-specific clinic name, date, and trial reference. All messages follow the Ethics-approved participant communication script.
  3. Click "Send Batch Nudges" — Sends the reminder to all participants with visits in the upcoming 7-day window. The system shows the count of upcoming visit participants.
📱
Why multilingual matters Clinical trial drop-out in South Africa often has nothing to do with adverse events — it's logistical. Participants miss visits because they didn't understand the appointment reminder (sent in English), couldn't afford transport (solved by stipends), or felt disconnected from the research process. Multilingual nudges address the first barrier directly.

Instant Transport Stipend Disbursals

Transport stipends are reimbursements approved by the ethics committee to cover the cost of travel to the clinic. EzSiteOS automates their disbursal through Ozow instant EFT and mobile money platforms.

  • Trigger — Stipend disbursals are automatically triggered when the nurse checks in the participant at the start of the visit (linked to the eSource encounter log).
  • Methods — Instant EFT (linked to participant's bank account) or Mobile Money (for unbanked participants).
  • Ethics Reconciliation — 100% of disbursals are reconciled against the ethics-approved stipend schedule. No cash handling on-site.
  • Audit — The disbursal log shows each transaction: participant code, clinic, amount, and payment method. All entries are timestamped and immutable.

Key Retention Metrics

  • Network Average Retention — 94.5% (target range: 85–96%).
  • Scheduled Visits (Next 7 Days) — 148 upcoming appointments across all spoke clinics.
  • Confirmed Appointments — 139 confirmed (93.9% confirmation rate).
  • Automated Reminders Sent — 412 WhatsApp/SMS reminders dispatched this cycle.
  • Total Stipends Disbursed MTD — R 486,250 disbursed month-to-date, 100% ethics-reconciled.
Module 5

🚨 Sentinel Surveillance

EzCRO's standing sentinel surveillance network is part of its Service 03: Pandemic Preparedness & Rapid Response. When outbreak signals exceed baseline thresholds, EzCRO can activate a full clinical trial in 72 hours — faster than any standard trial startup process.

Understanding the Surveillance Console

The console has two panels:

  • Pandemic Response State Card — Shows the current network readiness status (Standing Surveillance & Early Signal Detect) and provides the surge activation control.
  • Sentinel Surveillance Feed — A real-time table of syndromic signal readings from each sentinel node, updated continuously.

Reading the Surveillance Feed

Each row in the surveillance table represents one sentinel node:

  • Node & Site — The sentinel node name and its spoke clinic.
  • Syndromic Indicator — The specific pathogen screen or syndromic panel being monitored (e.g., ILI Screen, Acute Febrile Syndromic Cluster, Atypical Respiratory PCR Multiplex).
  • Weekly Volume — The number of cases presenting with that syndromic pattern in the past 7 days.
  • Baseline Deviation — How far the current volume is from the site's 3-year baseline (e.g., +14.1% = Watch Alert; -2.4% = Below baseline, normal).
  • Signal Status — One of three states:
  • NORMAL_BASELINE — Within acceptable deviation; no action required.
  • WATCH_ALERT — Deviation exceeds 10%; enhanced monitoring and notification to the SMO lead.
  • CLEAR_MONITORED — Actively monitored but below baseline; low-risk status.

The 72-Hour Rapid Protocol Surge

The "Activate 72-Hour Rapid Protocol Surge" button triggers EzCRO's emergency trial activation protocol:

  • All 8 network sites are alerted simultaneously.
  • Cold-chain logistics are prioritized for investigational product transport.
  • Pre-approved IRB/ethics fast-track frameworks (already in standing approval) are triggered.
  • GCP investigators are placed on standby at hub sites within 24 hours.
  • Sentinel nodes begin intensive sampling under the activated protocol within 48 hours.
  • First Participant In (FPI) is achievable within 72 hours of activation.
🚨
UAT Note: Surge Activation is Simulated In this UAT environment, clicking "Activate 72-Hour Rapid Protocol Surge" runs a simulation only. No real alerts are sent. In production, this action triggers real notifications to Principal Investigators, the SMO network, and the SAHPRA Emergency Use Authorization desk.
Module 6

🛡️ SAHPRA & eTMF Regulatory Audit

The Regulatory module gives investigators, sponsors, and regulatory affairs staff a continuous, inspection-ready view of EzCRO's compliance posture — across SAHPRA, ICH-GCP, FDA 21 CFR Part 11, and the African Medicines Agency (AMA).

SAHPRA Milestone Tracker

This timeline tracks the standard South African regulatory pathway for a clinical trial:

  • Protocol Submission (Day 0) — The formal submission of the protocol dossier to SAHPRA and the NHREC-accredited ethics committee. Status: ✅ Completed.
  • Ethics Review (Week 4.8 avg) — The NHREC accredited committee's review and approval of the protocol, informed consent forms, and participant communication materials. Status: ✅ Approved.
  • IMP Import Permit Verification — SAHPRA's review and issuance of the Investigational Medicinal Product (IMP) import permit. Status: ⏳ Under Review (ETA 3 Days).
  • First Patient In (FPI) Target — The date by which the first participant is enrolled and the first dose administered. Target: ≤ 7 days post import permit clearance.

ALCOA+ Data Integrity Standard

All data captured in EzSiteOS meets the five ALCOA+ pillars mandated by FDA and ICH:

  • ✅ Attributable — Cryptographic digital sign-offs by GCP-certified staff. Every record is tied to a named, certified investigator or coordinator.
  • ✅ Legible — Native digital source records with no handwritten transcription. Eliminates transcription errors that are the most common cause of data queries.
  • ✅ Contemporaneous — Records are timestamped at the exact moment of patient visit — not from paper notes entered later.
  • ✅ Original — The eSource record is the original source document. There is no paper CRF that is "the original."
  • ✅ Accurate — Automated sanity range validation on all vitals and eligibility criteria at point of entry.

Africa Clinical Trials Advantage

This panel articulates EzCRO's strategic differentiator for international sponsors:

  • 1.4 Billion patients — The world's most genetically diverse patient pool across 54 countries, enabling diversity-driven trial design and broader generalizability of results.
  • 4% → 15% — EzCRO's mission to grow Africa's share of global clinical trial activity from the current 4% to 15% — increasing access to investigational medicines for African patients and accelerating global drug development.
  • Zero Major GCP Audit Non-Conformances — EzCRO's unbroken record across all trials and inspections.
📋
For Regulatory Affairs Staff The SAHPRA Milestone Tracker is the at-a-glance reference for inspection readiness. If a milestone is shown as Under Review or Pending, escalation to the Regulatory Affairs Lead at EzCRO should be triggered if the ETA is overdue by more than 2 working days.
Compliance Reference

⚖️ Compliance & ALCOA+ Reference

EzSiteOS is built from the ground up for regulatory inspection readiness. This section explains the key frameworks that govern its operation and what they mean for your day-to-day work.

FDA 21 CFR Part 11 — Electronic Records & Signatures

21 CFR Part 11 is the US FDA regulation governing electronic records and electronic signatures in clinical trials. EzSiteOS complies through:

  • SHA-256 cryptographic hashing of all encounter records — tamper-evident and non-repudiable.
  • Timestamping at point of data entry — satisfying the "contemporaneous" requirement.
  • Named-person digital attribution on every record — satisfying the "attributable" requirement.
  • Audit trail preservation — all records are append-only; amendments create new entries rather than overwriting.

ICH-GCP E6(R2) & E6(R3)

The International Council for Harmonisation Good Clinical Practice guidelines define the global standard for trial conduct. Key obligations in EzSiteOS:

  • Investigators must be identified by name and GCP certification number in every eSource record.
  • Informed consent must be documented before any trial procedure — represented by the Screening & Informed Consent visit milestone in the eCRF.
  • Adverse events must be flagged explicitly — the Adverse Events Reported field in the encounter form triggers escalation protocols in a production system.

SAHPRA — South African Health Products Regulatory Authority

SAHPRA is the national medicines regulator for South Africa. Clinical trials require:

  • SAHPRA Clinical Trial Application (CTA) approval before First Patient In.
  • NHREC-accredited ethics committee approval.
  • IMP Import Permit for any investigational product manufactured outside South Africa.
  • Annual safety reporting and SUSAR (Suspected Unexpected Serious Adverse Reaction) reporting within 7–15 days of occurrence.

ALCOA+ in Practice

When you are entering data in the eSource module, always ask yourself:

  • Is this record attributable to me specifically, with my GCP number? ✅
  • Is the data entry legible and unambiguous? ✅
  • Am I entering this data right now, at the patient's visit? (If not, flag it as an amendment.) ✅
  • Is this the original source — not a transcription from paper? ✅
  • Are my vitals entries accurate — not rounded or estimated? ✅
📌
Inspection Readiness Standard EzSiteOS is designed so that an inspector from SAHPRA, FDA, or EMA can sit down at any workstation and trace any data point from the audit trail back to the original encounter, the coordinator who entered it, the visit protocol milestone, and the investigational product lot — all in under 3 minutes.
Reference

📚 Glossary

Key terms used throughout EzSiteOS and clinical research in the African context.

ALCOA+
Attributable, Legible, Contemporaneous, Original, Accurate — the five pillars of data integrity mandated by FDA and ICH for clinical trial records. The "+" adds Complete, Consistent, Enduring, and Available.
AMA
African Medicines Agency — the continental regulatory body established under the African Union to harmonize medicines regulation across Africa.
CRO
Contract Research Organization — a company that provides research support services to pharmaceutical, biotechnology, and medical device industries. EzCRO is a Pan-African CRO.
CTA
Clinical Trial Application — the formal regulatory submission to SAHPRA required before a clinical trial can commence in South Africa.
eCRF
Electronic Case Report Form — the digital equivalent of the paper CRF used to record protocol-mandated data for each participant at each visit.
eSource
Electronic source data — the primary, original capture of clinical data in electronic form, as opposed to paper. In EzSiteOS, all eSource records are the original source documents.
eTMF
Electronic Trial Master File — the complete regulatory filing for a clinical trial, containing all essential documents required by ICH E6. EzSiteOS maintains inspection-ready eTMF status continuously.
FPI
First Patient In — the date and time the first participant is enrolled in a trial and receives the first dose or intervention. A key milestone tracked in the SAHPRA Milestone Tracker.
GCP
Good Clinical Practice — the international ethical and scientific quality standard for designing, conducting, recording, and reporting trials involving the participation of human subjects (ICH E6).
Hub Site
An academic tertiary hospital research center in EzCRO's Hub & Spoke network. Carries full cold-chain, biobanking, and ethics infrastructure.
ICH
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use — the global body that produces GCP and other pharmaceutical standards.
ILI
Influenza-Like Illness — a syndromic surveillance indicator comprising fever, cough, and myalgia. One of the key signals monitored by EzCRO's sentinel nodes.
IMP
Investigational Medicinal Product — the drug or biologic being tested in the clinical trial. Import of IMP into South Africa requires a SAHPRA import permit.
NHREC
National Health Research Ethics Council — the statutory body under South Africa's National Health Act that accredits Research Ethics Committees (RECs).
PI
Principal Investigator — the medically qualified individual responsible for the conduct of a clinical trial at a given site. Must be GCP-certified.
SAHPRA
South African Health Products Regulatory Authority — the national regulator for medicines, medical devices, and clinical trials in South Africa.
SHA-256
Secure Hash Algorithm 256-bit — the cryptographic hash function used by EzSiteOS to generate tamper-evident fingerprints of all eSource encounter records.
SMO
Site Management Organization — manages the operational conduct of clinical trials at research sites. EzCRO is both a CRO and an SMO network.
Spoke Site
A primary care / community health center in EzCRO's Hub & Spoke network. Located where participants live, driving superior retention rates vs. urban hospital-only trial models.
SUSAR
Suspected Unexpected Serious Adverse Reaction — a serious, unexpected adverse event that may be causally related to the investigational product. Must be reported to SAHPRA within 7 (fatal/life-threatening) or 15 (other) calendar days.
TMF
Trial Master File — the essential document filing for a clinical trial, demonstrating that the trial was conducted in accordance with GCP and applicable regulations.
21 CFR Part 11
US FDA regulation (Title 21, Code of Federal Regulations, Part 11) governing electronic records and electronic signatures. Requires audit trails, access controls, and tamper-evident records for clinical trial data.
FAQ

❓ Frequently Asked Questions

Answers to the most common questions from first-time EzSiteOS users.

General

Q: Do I need to install any software?

No. EzSiteOS runs entirely in your browser. It works on Chrome, Firefox, Safari, Edge, and mobile browsers (iOS Safari and Android Chrome). No app download is required.

Q: What happens if I lose internet mid-session?

EzSiteOS is offline-first. Any encounter data you enter while offline is queued in your browser's local storage. When connectivity is restored, records sync automatically to the audit trail. You will see the connection badge update from "Offline — Data Queued" to "Online (Sync Active)" when sync completes.

Q: Is this the production system?

No. This is the UAT (User Acceptance Testing) environment at https://ezcro.mpondoland.com. All data here is simulated. The production system is a separate, validated environment with full data management agreements and live participant data protections. Contact the EzCRO IT team for production access credentials.

eSource / eCRF

Q: What is the Participant Code format?

Participant codes follow a site-prefix + sequential number format, e.g., SOW-1049 (Soweto site, participant 1049), KHA-2099 (Khayelitsha site), UML-3011 (Umlazi site). Never use a participant's real name, ID number, date of birth, or phone number as an identifier in any field.

Q: What if I made a mistake in a submitted encounter?

In a production system, you cannot delete or overwrite an encounter (per 21 CFR Part 11 and ALCOA+). Instead, you submit a correction/amendment record that references the original Encounter ID, states the original incorrect value, the corrected value, and the reason for change. Contact your site's Data Manager for amendment procedures.

Q: What does the SHA-256 hash prove?

The hash is a cryptographic fingerprint of the entire encounter record at the moment it was saved. If anyone subsequently modifies even a single character in the record, the hash will be different. This proves the record has not been tampered with — a core requirement of 21 CFR Part 11 §11.10(e) (Audit trails).

Feasibility

Q: Can I use the feasibility output in a sponsor proposal?

The UAT feasibility output is for training and demonstration purposes only and must not be included in formal sponsor proposals. In production, feasibility reports carry a unique reference ID and can be formally submitted to sponsors as part of an RFP response. Contact EzCRO's Business Development team for production feasibility reports.

Q: Why does the feasibility score sometimes say "FEASIBLE WITH EXTENDED SPOKE RECRUITMENT"?

This verdict appears when the projected enrollment velocity (based on matched site capacity) would exceed your target timeline, OR when the sample size is large enough that spoke sites need to be activated to supplement hub enrollment. It is not a negative result — it means the trial is still feasible, just with a fuller site activation plan.

Retention & Stipends

Q: Can I send nudges in a language not listed?

The current release supports isiZulu, isiXhosa, Sesotho, Swahili, and English. Additional language support (Afrikaans, Chichewa, Hausa, Amharic) is on the product roadmap for Phase 2. Contact the EzCRO Product team to prioritize your language.

Q: Are stipend amounts fixed?

No. Stipend amounts are protocol-specific and ethics-approved. They vary by visit type (a screening visit may carry a different amount than a final cohort visit), site location, and transport distance. The ethics committee reviews all stipend schedules to ensure they are reasonable and not coercive. EzSiteOS enforces the approved schedule — coordinators cannot disburse amounts above the approved limit without a protocol amendment.

Surveillance

Q: What triggers a WATCH_ALERT status?

A WATCH_ALERT is triggered when a sentinel node's weekly case volume exceeds 10% above the 3-year baseline for that indicator at that site. The threshold is calibrated per site and per season to avoid false positives from predictable seasonal spikes (e.g., winter flu season).

Support

📞 Support & Contacts

For questions about using EzSiteOS, reporting technical issues, or requesting production access, use the contacts below.

EzCRO Inc. — Key Contacts

  • Platform Support (UAT) — For technical issues with the EzSiteOS UAT environment: support@ezcro.africa
  • Regulatory Affairs — For SAHPRA milestone queries, SUSAR reporting guidance, and ethics escalations: Contact your assigned Regulatory Affairs Lead at EzCRO.
  • Data Management — For eCRF query resolution, eSource amendments, and data lock procedures: Contact your assigned Data Manager.
  • Business Development — For production feasibility assessments, sponsor RFP support, and clinical partnership enquiries: bd@ezcro.africa
  • EzCRO Websitehttps://ezcro.africa

Platform Technical Information

  • Service Nameezsiteos
  • UAT URLhttps://ezcro.mpondoland.com
  • Service Port3800
  • Health Checkhttps://ezcro.mpondoland.com/healthz
  • Version0.1.0
  • Regulatory Compliance — SAHPRA / ICH-GCP E6(R2) / 21 CFR Part 11
  • Estate Control Plane — JCDS (JolaCorp Control Plane)
  • UAT Hostmpondoland.com
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Ownership & Deployment Architecture Binteca Clinical SiteOS is developed, maintained and owned by Binteca (Pty) Ltd as part of the Binteca Health suite. This instance is deployed for client EzCRO Inc., a Pan-African Clinical Research Organization (CRO) and Site Management Organization (SMO) network headquartered in Johannesburg, South Africa.

Client Mission (EzCRO Inc.): To grow Africa's share of global clinical trial activity from 4% to 15% — ensuring that Africa's 1.4 billion people have access to the medicines being developed for a globally diverse patient population.

Built on Africa. Built for the World.