At the Site
Reminders Depend on Someone Remembering
Coordinators call and text participants from personal handsets between visits. When a coordinator is on leave or leaves the study, the contact history leaves with them.
Unified Trial Messaging Hub
Study Messaging in One Compliant Hub.
Clinera Communications brings participant reminders, site queries and safety broadcasts into one role-scoped workspace. Teams can send across Email, SMS, WhatsApp and In-App while every delivery, read and reply stays audit logged.
- Email, SMS, WhatsApp and In-App
- 21 CFR Part 11 Audit Log
- Event-Driven Triggers
- Role-Scoped Channels
The Problem
Where Trial Communication Breaks Down.
Communication failures rarely show up as communication failures. They show up as an empty visit slot, a query sitting open past its SLA or a participant who stopped answering three weeks ago and nobody noticed.
Across the Study
Queries and Notices Get Buried
Monitoring queries, protocol amendments and safety notices travel by email, so responses scatter across threads and nobody can say with certainty who read what.
At Inspection
No Record That Holds Up
Unencrypted email and personal messaging apps produce no auditable trail, which turns a simple inspection question into a manual reconstruction exercise.
The Solution
One Hub for Every Trial Conversation.
Clinera Communications brings participant messaging, site-to-sponsor correspondence and monitoring queries into a single role-permissioned workspace that sits on top of your study record. Messages, visit reminders, broadcast alerts and query nudges are logged with cryptographic timestamps as they are sent, so compliance evidence is produced by normal use rather than assembled afterwards.
01
Four Channels, One Thread
Email, SMS, WhatsApp and in-app messages sit in the same conversation record, whichever route the recipient prefers.
02
Role-Scoped Access
Coordinators, monitors, sponsors and participants each see only the channels their role permits.
03
Automated Outreach
Visit reminders, pending ePRO nudges and query escalations fire on study events without staff intervention.
04
Audit-Ready by Default
Every send, delivery and read event is written to an immutable log with sender, recipient, timestamp and channel.
How It Works
From Study Setup to Inspection Evidence.
Configuration happens once per study. After that the hub runs off study events, and the audit record builds itself.
Connect the Study
Sites, arms, visit schedules and participant contact preferences are pulled from the Clinera study record, so no separate contact list is maintained.
Set Channels and Rules
Choose a channel per message type, set failover timing, define who can broadcast to sites and approve the message templates.
Messages Dispatch on Events
Scheduled visits, incomplete questionnaires and ageing queries trigger outreach automatically. Staff message manually inside their scoped channels.
Everything Stays Retrievable
Send, delivery and read events land in the Part 11 log, searchable later by keyword, date range, site or participant ID.
Capabilities
Core Features and Capabilities.
Four feature blocks cover the delivery layer, the channel structure that keeps conversations separated by role, the automation that removes routine outreach from coordinator workload, and the compliance controls underneath all of it.
Feature 01
Omnichannel Delivery Engine
Reach each recipient through the medium they actually read, and escalate automatically when they do not.
- WhatsApp Business API - Branded appointment reminders and survey links sent to the participant's handset.
- SMS Gateway - High-deliverability global dispatch for notifications and one-time security codes.
- Email Pipeline - HTML-formatted formal trial communications with delivery, open and bounce tracking.
- In-App Notification Drawer - Real-time badges and alert counters inside Clinera for site staff and CRAs.
- Smart Delivery Failover - An unread in-app push steps up to WhatsApp after 30 minutes, then to SMS if it remains undelivered.
Delivery Engine
Channel Failover
01
In-App
Unread After 30 Min
02
Delivered to Handset
03
SMS
Fallback Alert Sent
04
Formal Notice Logged
Feature 02
Role-Scoped Channel Workspaces
Keep conversations in purpose-built channels instead of one shared inbox.
- Coordinator to Participant Threads - Keep logistical support close to the visit schedule without exposing personal numbers.
- Site to Sponsor Workspace - Centralize protocol notices, operational updates and sponsor follow-ups.
- CRA to Site Query Channel - Link data clarifications to the query, form or participant record they concern.
- Urgent Safety Broadcasts - Send time-sensitive notices to active investigators and retain delivery/read evidence.
Workspace Access
Role-Scoped Channels
CoordinatorParticipants, Visits, Site QueriesFull
CRAOpen Queries and Source ClarificationMonitor
SponsorProtocol Notices and Site BroadcastGovern
ParticipantOwn Reminders and Support ThreadLimited
Feature 03
Automated Event-Driven Nudges and Reminders
Take routine trial outreach off the coordinator's task list.
- Visit Reminders - Send 48-hour and 2-hour reminders based on the active visit schedule.
- Pending ePRO Nudges - Prompt participants when a questionnaire remains incomplete inside its response window.
- Query Escalation SLA - Escalate ageing data queries to the right role before they block cleaning and lock.
Automation Rule
Visit 04 Adherence
1
48h Before Visit
Email and WhatsApp Reminder Sent
2
2h Before Visit
SMS Fallback if Unread
3
ePRO Incomplete
Coordinator Nudge Generated
4
Query Ageing
CRA Escalation After SLA Threshold
Feature 04
21 CFR Part 11 Audit Trail and PHI Privacy
Built for healthcare compliance rather than retrofitted to it.
- Immutable Message Log - Every send, delivery and read event is retained with sender, recipient, timestamp and channel metadata.
- PHI and PII Auto-Masking - External payloads stay generic while identifiable detail remains inside the encrypted portal.
- Role-Based Visibility - Sponsors, monitors, investigators, coordinators and participants only see the conversations their role authorizes.
Compliance Record
Message Audit Log
EventChannelTimestamp
SentWhatsApp10:00:04
DeliveredWhatsApp10:00:11
ReadWhatsApp10:03:54
ReplyIn-App10:04:18
External Payload
You have a study reminder. Open the secure portal to view details.
Use Cases
What Teams Run Through the Hub.
Four recurring jobs account for most of the messaging volume on a running study.
Visit Adherence
Reminders at 48 hours and 2 hours, delivered through the channel each participant responds to, with rescheduling handled in the same thread.
Fewer Missed Visits
Query Turnaround
Monitoring queries carry their own thread tied to the eCRF form, so the context is never separated from the data issue.
Faster Query Closure
Safety and Protocol Broadcasts
Urgent notices reach active investigators and sites, while delivery and read state is recorded automatically.
Provable Notification
Participant Support and Retention
Participants can ask logistical questions without exchanging personal phone numbers with study staff.
Better Retention
Workflow
Role-Based Workflow and Benefits.
The same message log serves four different jobs. Coordinators chase attendance, monitors chase queries, sponsors govern site communication, and participants get reminders they can act on.
RoleKey Capabilities in Clinera CommunicationsKey Benefit
Coordinator (CRC)
Manage appointment reminders, send direct participant nudges and answer visit questions.
Fewer no-shows and fewer participants lost to broken contact.
CRA / Monitor
Message coordinators about open queries and request source document clarification in the query thread.
Faster query resolution without long email chains.
Sponsor / CRO lead
Broadcast protocol notices to all sites, review communication history and track site responsiveness.
Governance over site communication and safety announcements.
Trial Participant
Receive visit reminders by WhatsApp or SMS and ask coordinators logistical questions.
Stays informed and supported across the full study.
Why Clinera Communications
What Makes Clinera Communications Different.
01
One Record Across Channels
A WhatsApp reminder, an email follow-up and an in-app reply belong to the same thread and the same audit entry, so nobody reconstructs a conversation from three systems.
02
Privacy Enforced at Send Time
External payloads are masked automatically. Participants receive a generic reminder and a secure link, which keeps identifiable detail inside the encrypted portal rather than in a phone message history.
03
Evidence Without Extra Work
The Part 11 log is a by-product of normal use. When an inspector asks who was notified of a protocol amendment and when, the answer is a search rather than a week of email retrieval.
Specifications
Technical and Security Specifications.
Clinera Communications is deployed as part of the Clinera platform and inherits its security, audit and access-control model.
- Channels Supported
- Email (SMTP / SES), SMS (Twilio / Infobip), WhatsApp Business API, web push and in-app messaging over WebSockets.
- Security Protocols
- AES-256 encryption at rest, TLS 1.3 in transit and ISO 27001 certified infrastructure.
- Search Engine
- Full-text indexing so data managers and auditors can search message history by keyword, date range, site or participant ID.
- Audit Logging
- Immutable log of every send, delivery and read event, with sender ID, recipient ID, timestamp and channel metadata retained for 21 CFR Part 11 evidence.
- Access Control
- Role-based visibility rules applied per channel, so monitors, investigators and sponsors see only what their role authorizes.
- Delivery Logic
- Configurable failover between channels with per-step timing, plus delivery, open and bounce tracking on email.
FAQ
Frequently Asked Questions.
Can Trial Participants Reply Directly to SMS or WhatsApp Messages?+
Yes. Replies are routed automatically into the assigned site coordinator's secure Clinera Communications inbox, which creates a two-way thread that is audit-logged like any other message.
Is Patient Health Information Protected When Sending WhatsApp or SMS Messages?+
Yes. External messaging payloads are designed to exclude PHI and PII. The participant receives a generic notification, for example that an appointment is coming up, with a secure link to view the details inside the encrypted portal.
What Happens if a Participant or Coordinator Does Not Read a Message?+
Delivery failover handles it. A message can start as an in-app push and, if it stays unread for a defined period, step up to WhatsApp and then to SMS. Each attempt and its outcome is recorded against the same thread.
Can an Auditor Retrieve the Full Communication History for a Site or Participant?+
Yes. The message log is immutable and fully indexed, so history can be searched by keyword, date range, site or participant ID and exported with sender, recipient, timestamp and channel metadata intact.
Do Sponsors and Monitors See Private Messages Between Coordinators and Participants?+
Not unless their role explicitly permits it. Channels are scoped by role, and RBAC policies control which conversations each user can open. Sponsors and CRAs typically see study-level and query channels rather than participant threads.
Get Started
Schedule a Clinera Communications Demo.
Bring one visit schedule and your current reminder process. We will configure the channels, failover rules and broadcast permissions live on the call.