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.
Elevate transparency with strategic & hands-on services
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
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。
Citeline Regulatory & Compliance solutions
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A specialist is ready to speak to you regarding your interests and find the solutions that are right for you.
