Streamline Clinical Trials with Cloudbyz Unified eClinical Platform

In a Tufts CSDD study of 257 sponsors and CROs, companies used an average of six applications to support each clinical study, and 77% reported difficulty loading data into their primary EDC system because of compatibility, technical and integration challenges (Tufts CSDD via GlobeNewswire).

Six applications means six places where the same study, site, subject and visit are set up, and a set of interfaces that copy data between them on a schedule. Every interface is something to build, validate, monitor and fix when either side changes. When CTMS, EDC, eTMF, safety and financials share one platform and one data model, those interfaces between them are not needed, and the data each team sees is the same data, at the same time.

Separate systems versus one platform

1. Data is set up once

Studies, sites, investigators and visit schedules are created once and used by every module. That removes the reconciliation work that follows when the same site is spelled differently in three systems, and it makes study start-up faster because nothing is re-keyed.

2. Everyone sees real-time data

When enrolment is entered in EDC, it appears in CTMS dashboards straight away, rather than after the next scheduled sync. Clinical operations leaders can see enrolment, visit completion, open queries, monitoring status and TMF completeness together, from records that are already current.

3. No interfaces to build or maintain between modules

Point-to-point interfaces between systems need to be specified, built, validated and monitored, and re-tested when either side is upgraded. When modules share one data model, there are no interfaces between them to maintain. Integrations are still needed with systems outside the platform, such as central labs or a hospital's EHR, but the internal ones go away.

4. Payments follow the work

A completed visit in EDC or CTMS can drive the earned amount in the site budget. Finance does not wait for a report from clinical operations, and sites can be paid against data that is already in the system.

5. Safety and documents stay connected

An SAE entered at the site can be shared with the safety case instead of being re-entered. Monitoring reports, site documents and approvals can be linked to the eTMF as they are created. Both reduce reconciliation and support the traceability that ICH E6(R3) expects from computerised systems (ICH E6(R3), EMA Step 5).

6. One login, one role model, one audit trail

Users, roles and permissions are managed once. Site staff and monitors have fewer accounts to manage, and auditors can follow a record from site entry to report in one trail rather than matching logs from several systems.

Questions to ask about any "unified" eClinical suite

• Do the modules share one data model, or are they connected by interfaces?
• When enrolment is entered, how soon does it appear in the CTMS dashboard?
• Is a site or study set up once, or in each module?
• Do completed visits drive site payments without an export?
• Is there one login and one role model across modules?
• Is there a single audit trail across modules?
• Can you start with one or two modules and add others later?
• Which external integrations are available for labs, EHRs and sponsor systems?

What this means by role

• Clinical operations directors and associate directors: one real-time view of enrolment, monitoring, data and documents across studies.
• Clinical operations managers and CTMs: less time reconciling numbers between systems before status meetings.
• Clinical data managers: fewer data loads and no internal interfaces to monitor.
• eTMF managers: documents and monitoring evidence reach the TMF as they are created.
• Quality and compliance directors and QA auditors: one audit trail and one validation scope for the connected modules.
• CRAs, CRCs and principal investigators: fewer logins, and less re-entry of the same information.

How Cloudbyz approaches this

Cloudbyz eClinical is built natively on Salesforce as one platform. CTMS, Study Start-Up, CTFM, eTMF, EDC, ePRO and eCOA, RTSM, Safety and Pharmacovigilance and Patient Recruitment share the same data model, with portals for sites, sponsors, CROs and patients. Because the modules are part of one platform rather than separate systems, they do not need interfaces between them: a site, subject or visit recorded in one module is available in the others, and dashboards show the data in real time.

The platform is modular, so an organisation can start with one or two products and add more later. Cloudbyz also offers integrations with external systems where a study needs them. How much reconciliation this removes depends on which modules are in use and how each study is configured.

The Cloudbyz AI agents, built on Agentforce, run on the same platform and data, including the CRA Monitoring Copilot, Protocol Intelligence Agent, Financial Navigator and AI eTMF Agent, each with a defined limit on what it may do.

Frequently asked questions

What is a unified eClinical platform? A set of clinical trial applications, such as CTMS, EDC, eTMF, safety and financials, that share one data model, so information entered in one is available in the others without interfaces.

Does a unified platform remove the need for all integrations? It removes integrations between its own modules. Systems outside the platform, such as central labs, EHRs or a partner's systems, still need integrations.

How does a unified platform give real-time data? Because every module reads and writes the same records, a change in one is visible in the others immediately, rather than after a scheduled transfer.

See the whole suite on one platform

Book a demo or visit cloudbyz.com.