TrialScope Disclosure Services

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Managing clinical trial submissions and disclosure requirements is challenging with conflicting application needs and document burden. With many moving parts, including tracking multiple trials, changing regulations, and submission deadlines, our services can help you:

Streamline high-quality submissions

Ensure regulatory compliance

Be inspection-ready

Increase patient engagement

Safeguard your brand reputation

From protocol registration, results disclosure, and redactions we offer a range of hands-on services to help companies small and large manage their clinical trial transparency and disclosure processes in line with local and global requirements and regulations.

How it helps

If your team is stretched thin or you want to simply improve policies and processes, we can act as an extension of your team to provide the expertise and help you to maximize compliance and minimize risks.

Leverage our qualified team of regulatory and disclosure experts, each with over seven years of experience, to support your specific disclosure challenges and needs, helping you to reduce risks of noncompliance, avoid sanctions and fines, and any reputational damage to your business.

Our services include:

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

Protocol Registration

Results Disclosure

Plain Language Summaries

Redaction

How it works

You don't have to manage disclosure compliance alone. Outsource your disclosure tasks to reduce submission cycle times and increase efficiency. Select the services you need and scale them to fit your organization priorities, and changing regulatory needs:

Protocol Registration
Plain Language Summaries (Results and Protocol)
CTIS/EudraCT-specific tasks
Results Disclosure
Redaction
Advisory Services / Workshops

A person standing in front of a glass wall with sticky notes.

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。

Speak to a specialist

Request a demo with a Citeline expert to see how our services make the clinical trial disclosure process easier.

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