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Clinical Trial Operations Management

Bring clarity, speed, and control to global research portfolios with a unified system of record.

Isos for Clinical Trial Operations

Clinical research organizations running complex trials often rely on spreadsheets, email, meetings, and disconnected systems to manage critical work. That makes it harder to maintain visibility, coordinate handoffs, manage protocol changes, and respond to blockers across distributed teams.

Isos helps solve that with a clinical operations execution layer built on Atlassian. We design the workflow model, configure the tools, and implement the solution so teams can standardize work, reduce status chasing, and scale operations with more control. The result is a clearer, more scalable way to manage trial execution alongside CTMS, eTMF, and EDC.

Solutions for Clinical Trial Operations

Study Start-Up Coordination

Standardize intake, approvals, handoffs, and site activation work so teams can identify blockers earlier and move studies forward with less manual follow-up.

Protocol & Amendment Workflow Management
Coordinate protocol-related work across stakeholders with clearer ownership, traceability, and workflow discipline.
Cross-Functional Trial Execution
Bring operational work, status, dependencies, and reporting into one shared workspace so clinical operations, PMO, and supporting teams can work from the same view of progress.
Operational Visibility & Reporting
Give teams and leaders better visibility into work status, resource demands, and delivery risk through dashboards, reporting, and workflow-based execution.

Why Partner With Us?

You need a partner that can understand your operating model, design the right workflows, and deliver a solution your teams can actually use.

Atlassian expertise at scale

We're an Atlassian Platinum and Enterprise Solution Partner with specializations in Service Management, Cloud, and Enterprise Strategy and Planning. We bring deep platform knowledge to complex delivery work.

Experience that translates to outcomes

We have deep experience across industries, including healthcare and life sciences, and a track record of helping organizations improve workflows, visibility, and operational performance.

Services built around your needs

Isos combines process design, implementation, optimization, integration, and change support to deliver solutions that fit how your teams work.

A proven delivery approach

We use a structured, phased approach that starts with discovery and planning, then moves through build and transition with clear alignment to business goals.

Our Clinical Trial Operations Management Solution includes:

The Isos Clinical Trial Operations Management solution combines strategy, configuration, and delivery support into one repeatable engagement model.

Process & Workflow Design

We map and standardize how operational work should move across teams, from study start-up through ongoing trial execution.

Atlassian Configuration

We configure Jira, Confluence, Jira Service Management, Assets, and Rovo to support workflows, ownership, dashboards, automation, and reporting.

Implementation & Optimization Services

We support process optimization, implementation and configuration, integration, and organizational change management, training, and rollout so the solution works in practice, not just on paper.

Outcomes You Can Expect

Faster study start-up

Standardized workflows, automation, and early visibility into blockers help studies move forward with less friction.

Lower operational overhead

Replace manual status reporting, duplicate updates, and scattered coordination with an efficient operational model.

Better visibility & traceability

Give teams a clearer view of ownership, status, dependencies, and change across trial operations.

More scalable operations

Support growth, distributed teams, and more complex trials without adding the same level of administrative burden.

Proof in Practice

For the Knight Family DIAN-TU at Washington University in St. Louis, Isos helped strengthen operations for global Alzheimer’s clinical trials across 38 sites in 15 countries. Isos implemented six Jira projects, centralized study data with Assets, and added automations for trial workflows.

One enhancement alone saved 12 hours of manual work per week for a single drug arm, while the broader solution improved visibility into task ownership and status and reduced the need for meetings and status updates.

 

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Frequently Asked Questions

How is this different from a CTMS?

This solution is not a CTMS replacement: it acts as an execution and coordination layer that works alongside CTMS, eTMF, and EDC. It helps teams manage operational workflows, ownership, reporting, and cross-functional coordination around those systems.

Is this a software product or a services engagement?

It’s a solution delivered through services. Isos combines process design, Atlassian configuration, implementation, integration, and change support to create a repeatable operating model for clinical trial operations.

What kind of use cases does this support?

Study start-up coordination, protocol and trial management, patient or participant tracking, site start-up tracking, site-facing communication portals, cross-team collaboration, and reporting are relevant use cases.

Will this work in regulated environments?

The solution is designed to work alongside required validated systems rather than replacing them. That makes it well-suited for operational coordination and workflow management around regulated clinical processes.

Why Atlassian?

Atlassian is a strong fit because it supports configurable workflows, enterprise scalability, governance, and cross-functional collaboration.

Resources for You

Explore how Isos helps clinical teams improve study execution, reduce operational burden, and scale trial operations with better workflow design and visibility.

Let’s Improve Your Clinical Trial Operations

Tell us where trial operations are slowing down. We’ll learn how your teams work today, where coordination breaks down, and what you need to improve visibility, workflow consistency, and execution across studies. Then we’ll outline next steps using Atlassian, without disrupting your core clinical systems.

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