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Elevate transparency with strategic & hands-on services

Leverage a team of regulatory writing and clinical trial transparency experts, with a minimum of seven years' experience. Our medical writing and disclosure services include regulatory writing, protocol registration, results disclosure, plain language summaries and redaction. If your team is stretched too thin or you want to improve policies and processes, our team is ready to assist you in maximizing your regulatory and disclosure compliance and minimizing your risk.

How it helps

As a sponsor, you will know how difficult it is to manage your clinical trial submissions and disclosure requirements. There are so many moving parts before, during, and after each study, including tracking: multiple trials, ever-changing regulations, submission deadlines, and much more.

Whether you're a large, mid-size or small pharmaceutical company, your organization can benefit from outsourcing regulatory and disclosure-related tasks to:

Streamline high-quality submissions

Ensure regulatory compliance

Be inspection-ready

Increase patient engagement

Defend brand reputation

We are ready to assist in maximizing compliance and minimizing risk

Related resources

Infographic preview of The 9 Hidden Costs of Clinical Trial Disclosure.
OCT 06, 2023
Infographic
薬事規制関連支援サービス

9 Hidden Costs of Trial Disclosure

From system implementation to protocol registration and process assessment, hidden costs lurk at every step of the clinical trial disclosure process.

Trial Diversity from a Disclosure Perspective
JUN 03, 2024
Article
薬事規制関連支援サービス

Trial Diversity from a Disclosure Perspective

At Citeline’s TrialScope EXTRA event, this session focused on clinical trial diversity from FDA action plans and the perspective of disclosure compliance.

Trial Summaries-Improving Patient-Centric Communications resource-card-thumbnail
JUL 01, 2023
Whitepaper
薬事規制関連支援サービス

Trial Summaries Improving Patient-Centric Communications

The Pharma R&D Annual Review 2023 Supplement looks at new active substances (NASs), drugs launched onto the market for the first time, during 2022

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弊社の専門家
医薬品開発プロセスにおいて、規制は見過ごすことができない分野であり、多くの関係者に影響が及びます。Citelineの規制情報、ソリューション、およびサービスは、組織のコンプライアンス維持を支援します。Pink Sheetの20人以上のグローバルなジャーナリストチームは、バイオシミラー、ジェネリック医薬品、ブランド名/イノベーター医薬品など、提出から承認までの医薬品申請の進捗状況を追跡しています。臨床試験の開示に関して業界をリードする専門家が、TrialScope Disclose、TrialScope Intelligence、TrialScope Atlasソリューション、および開示サービスに関与しています。
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