Regulatory & Compliance

TrialScope Atlas

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The what, when, where & why of clinical trial information disclosure

Clinical trial sponsors are challenged to manage global disclosure requirements and answer questions about their regulatory compliance. Often, they rely on CROs and local affiliates to manage clinical trial disclosure, making it difficult to track requirements and manage compliance.

TrialScope Atlas helps to reduce costs, mitigate risk — and stay in compliance — by consolidating your disclosure requirements into a single automated dashboard.

Clinical trial sponsor ensuring compliance

Never miss a deadline again

How it helps

Atlas enables clinical trial sponsors to quickly and accurately provide an answer to the question: Am I compliant? In doing so, Atlas reduces the risk of non-compliance by providing real-l time access to consolidated, global disclosure compliance performance metrics.

How it works

Atlas is your all-in-one clinical trial disclosure tracking and management tool.

On a single, easy-to-use dashboard, you can:

Enter your summary clinical trial data — the platform scans for what’s relevant, globally
Receive automated prompts for evolving regional and national disclosure requirements — in real time
Track your disclosure performance against requirements and policies

What's included

Library of global compliance rules

Industry experts and our user community define compliance rules that automatically determine where and when clinical data must be disclosed – , with links to sources for each rule. Pre-set rules based on industry knowledge are continually being updated and modified.

Add rules to match your policy

Add rules from the library that reflect policies and standard operating procedures, enabling greater transparency than the law requires.

Manage on your performance

Automated task notifications and track compliance with performance dashboards that offer a snapshot of global compliance. Users can see what was disclosed and what was missed and then compare performance against current policies and the law.

Our experts

When it comes to the drug development process, regulatory is one area that simply cannot be overlooked; too much is at stake. Citeline’s regulatory intelligence, solutions and services help ensure that your organization maintains compliance.

Pink Sheet’s global team of over 20 journalists tracks marketing application progress from submission to approval, covering biosimilars, generics, brand name/innovator drugs and more.

The industry’s leading experts on clinical trial disclosure inform our TrialScope Disclose, TrialScope Intelligence and TrialScope Atlas solutions as well as our Disclosure Services.