Regulatory & Compliance

TrialScope Disclose

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The most widely trusted solution for clinical trial disclosure management

Managing clinical trial disclosures can be tedious and error-prone, opening the door to non-compliance. TrialScope Disclose provides a better way.

Our centralized platform automates data entry and reporting for Clinicaltrials.gov, CTIS, and more. This reduces manual effort so you can focus on bringing new treatments to patients, not paperwork.

Accelerated clinical trial disclosure starts here

TrialScope Disclose keeps you ahead of changing regulations and evolving expectations, empowering you to maintain global disclosure compliance from a single, centralized platform.

How it helps

Everyone benefits from better transparency around clinical trials. But in a complex and ever-evolving regulatory landscape, navigating the clinical trial disclosure process can be difficult for even the most diligent sponsors. Register the right data in the right place at the right time. TrialScope Disclose is powered by an intelligent disclosure rules engine that uses automation to keep you compliant across registries, even as regulations evolve.

Automated submissions to Clinical Trials

How do we help?

Improve speed and accuracy - automate submissions to ClinicalTrials.gov using validated fields.
Work more efficiently - slash data entry, review and approval times by up to 85%.
Collaborate with confidence - work whenever, wherever with field-level commenting and verified e-signatures.
Report your way - choose from pre-defined templates or ad-hoc creation.
Meet deadlines with ease - keep track of due dates with our proprietary disclosure rules library.
Tighten up your team - clarify tasks and timelines with role assignments and configurable workflows.
Always be audit ready - you’re well prepared with our full log conforming to 21 CFR Part II/Annex 11.
Repurpose trial data - sync your data across forms and registries.

It can help you to:

validate your data against field-level registry requirements.
evaluate your trials to determine what must be disclosed, on which registry, and by what date.
alert you of impending deadlines and can be modified to match internal policies/business rules.

TrialScope Disclosure Services

We’re here to help your organization master the complexities of disclosure any way we can — including doing the work for you. Our team of experts can act as an extension of your team and take your most time-consuming, cumbersome disclosure activities off your plate — from protocol registration through results posting — so you’re free to focus on the big picture.

What's included

Simplify and centralize disclosure compliance operations globally

Automate data entry and streamline processes to reduce manual effort and submit trial information quicker and more accurately

Mitigate regulatory risk, avoid penalties, build public trust and enjoy peace of mind

Easily track where you’re compliant, where you’re falling short and why — across your entire clinical trial portfolio

Re-use your approved trial data across different forms and global registries

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.