citeline-regulatory

Welcome to Citeline

From early stage portfolio decisions, clinical research and development, regulatory compliance and approval, to commercial planning and analysis, Citeline offers a suite of complementary pharmaceutical business intelligence tools and solutions to support your business strategy.

【新機能】 AI Importer を搭載

AI Importer を活用することで、臨床試験プロトコルを事前入力された登録フォームへと変換し、試験登録をより簡単・迅速に行うことが可能です。

  • プロトコル文書から主要なデータ項目を抽出し、フォームに自動入力。手作業による再入力を排除。
  • USDMやICH M11など、グローバルレジストリ要件に準拠。数千件の試験プロトコルで学習されたAIにより、正確なデータ構造化と完全な監査証跡を実現
  • 試験登録および試験データ提出をサポート。主要レジストリにおける開示要件を加速するため、関連項目を抽出

【新機能】 AI Importer を搭載
Explore case studies
A person in a blue shirt sits at a desk working on a client's clinical trial disclosure.
AUG 14, 2025
サービス活用事例
薬事規制関連支援サービス
How Citeline Services Help Sponsor with Global Clinical Trial Disclosure
In this case study, a large pharmaceutical sponsor in the rare disease space sought regulatory writing expertise from Citeline for a global submission.
Medical writing expert typing on a laptop keyboard with a blurred document on the screen.
AUG 14, 2025
サービス活用事例
薬事規制関連支援サービス
Citeline Expands Biotech’s Bandwidth with Regulatory & Medical Writing Services
In this case study, Citeline expands the bandwidth, expertise, and resources of a mid-size biotech to help handle its regulatory writing requirements.
Disclosure as a Service Case Study resource card thumbnail
DEC 01, 2019
サービス活用事例
薬事規制関連支援サービス
Small But Growing Biotech Manages Disclosure, Maintains Compliance, & Keeps Its Promise to Patients
While most large study sponsors place a high priority on transparency, smaller sponsors are not as quick to jump on the bandwagon. This one’s an exception.
Explore product flyers
''
APR 14, 2025
Product Information
薬事規制関連支援サービス
Get the Answers You Need Faster – A Guide to Citeline Regulatory Solutions
Clinical trial disclosure can be a heavy burden for biopharma. This guide provides an overview of how Citeline helps throughout the regulatory process.
Professionals accessing TrialScope Disclose to track trial compliancy and awareness of regulations.
Product Information
薬事規制関連支援サービス
Accelerated Clinical Trial Disclosure Starts Here
Manage the complexity of clinical trial disclosure and the risk of non-compliance by automating data entry and reporting to registries
Sponsors accessing TrialScope Intelligence for regulations and requirements.
Product Information
薬事規制関連支援サービス
Prepare for New Clinical Trial Disclosure Regulations
A centralized, interactive repository of the critical regulatory knowledge needed for global clinical trial disclosure compliance
Trial participants accessing TrialSummaries.com to learn more information about trials in plain language.
Product Information
薬事規制関連支援サービス
Trial Transparency Starts Here
This user-friendly portal aggregates clinical trial results summaries across sponsors
Citeline professionals providing hands on disclosure services.
Product Information
薬事規制関連支援サービス
TrialScope Services Flyer
Hands-on clinical trial disclosure services, from regulatory writing to registration to results
Citeline may contact you about relevant products, services, and content. To opt out of these communications or to manage what you receive, please visit our Preference Center.

Your information will be used in accordance with our Privacy notice.