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Country Summary page: Sourced from our relevant regulatory requirements pages and data fields for this country or region.
Requirements page: Your place to easily assess for a country what types of clinical trial data must be reported, when they must be reported and how they must be reported, such as in registries and formats.
Registry page: Detailed information relating to each national or regional clinical trial registry/database, worldwide. Please note that we do not cover academic or patient registries.
Disclose Perspectives Page: Exclusive articles by experienced journalists and disclosure experts to help you understand and anticipate disclosure and transparency developments, learn best practices and gain perspective on disclosure and transparency in context.
Analysis: Strategic advice and commentary from thought leaders in the field and updates on key trends.
Disclosure Developments: Key announcements in disclosure requirements and updates on related activities impacting this sector, such as enforcement actions, changes in decision makers, industry and patient advocacy and conference discussions.
Document Library page: Central resource for all documents issued by health authorities that are the sources for our database, plus professional English translations when relevant. Provided in PDF. The document library gives you additional detail and confidence in your understanding.
Glossary Page. Definition of terms related to clinical study/trials, and specific terminology applied to disclosure/transparency. This list provides the definition of terms related to clinical study/trial, including specific terminology applied to disclosure and transparency. Links to global international sources are provided as much as possible. The geographic coverage is mentioned (e.g., global or concerned country if country-specific). Abbreviation is provided when relevant.
How far back in time does the coverage go?
TrialScope Intelligence was launched Nov. 14, 2022 and covers all the requirements and updates from this point forward.
What information and sources does TrialScope Intelligence use? How many sources do you monitor overall?
We monitor hundreds of sources daily to capture all information that is relevant to the clinical trial disclosure function. Primary sources are health authority websites and the trial registry websites.
How often is TrialScope Intelligence updated?
We assess and review the accuracy of all content after it is curated from regulatory documents. The timelines for when added or updated information is uploaded depends on its size and complexity. Our updates would typically occur within 24-48 hours of publication by health authorities, but there may well be a longer lead time for major changes or creation of a new registry.
What is the process for updating TrialScope Intelligence?
We have a dedicated team of analysts and research managers experienced in this domain. The analysts monitor developments in the field continuously, and revise monitoring procedures as needed. They assess regulations for relevance, significance, and clarity; analyze and answer areas of uncertainty and then manually curate the information for the database. Research managers organize and input data and source documents, conduct QA (quality assurance) and publish validated new and updated data into the database.
What is the process for updating TrialScope Intelligence with Disclose Perspectives?
Our writers attend pertinent conferences and monitor regulatory and related news developments and trends. After assessing whether new information or ideas enhance understanding of the disclosure field, they may conduct further research or interviews before creating an article.
Who is responsible for updating TrialScope Intelligence?
Our core team of experts in regulatory intelligence and in the specific disclosure and transparency field train and supervise our analysts and validate database content. They have extensive experience in meeting customer needs with biopharma regulatory information and in understanding and working with disclosure regulatory requirements in industry and trial settings. Journalists experienced in reporting specialized policy and business information for biopharma professionals write and edit our Perspectives articles.
Does TrialScope Intelligence cover requirements for medical devices?
We currently cover requirements only for drugs, biologics and vaccines.
We plan to explore covering medical devices later, with input on our customers’ needs and interests.
Will customers be able to ask regulatory questions to experts?
Yes. The Ask the Analyst feature allows users to submit questions and get timely feedback from subject matter experts.
TrialScope Intelligence’s experts will assist customers with questions specific to clinical trial disclosure, how to build effective search strategies within the tool, and creative approaches to help answer their critical business questions. Our standard service offers up to three hours of analyst support per request, and Citeline’s Platinum clients enjoy up to four hours per request.