Technology that powers operational efficiencies

According to analysis by the Tufts Center for the Study of Drug Development, the average cost to develop and gain marketing approval for a new drug is $2.55 billion. A quarter of this cost is in content creation and meeting regulatory requirements.

Certara has developed leading technologies that save time and resources during the regulatory preparation and submission process, so you can get your therapeutics and medical devices to market faster.

As key opinion leaders, our regulatory technology specialists speak regularly at major industry events, including transparency and disclosure conferences, DIA meetings, PHUSE, and RAPS Regulatory Convergence.

Maximize your Data Fitness Score with Pinnacle 21

Pinnacle 21 offers a broad suite of solutions for your data needs: (スペック設定、割付、クリーニング、チェック、比較、変換、コンバージョン)を提供します。

Validation: Analyze your data quality, see issues that affect FDA/PMDA review, and get insights into fixes with our leading engine.

Issue management: Delegate, fix, or explain issues across decentralized teams and sites.

Define.xml: Create 100% compliant Define.xml files with our intuitive, automated designer.

Reviewer’s guide: Advocate for your data and share their full context in our xDRG creator.

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Maximize your Data Fitness Score with Pinnacle 21
GlobalSubmit eCTD Submissions Management Software

GlobalSubmit eCTD 承認申請管理
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Efficiently publish, validate and review electronic submissions.

  • GlobalSubmit PUBLISH:eCTD パッケージ作成および品質管理に対応したより効率性に優れた機能を搭載
  • GlobalSubmit VALIDATE:承認申請を計画する地域における申請文書の技術的有効性を検証
  • GlobalSubmit WebReview:オンデマンドの合理化された申請文書レビュー機能

GlobalSubmit CROSSCHECK:ブックマークとハイパーリンクの技術的な有効性を検証する品質管理プロセスを効率化することで、承認申請時に審査官が正しい項目を参照できるように支援

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Synchrogenix eCTD オーサリングテンプレート一式

We’ve paired our technical experts with our team of leading regulatory professionals to create a comprehensive eCTD authoring template suite. Based on our thirty plus years of planning, writing and publishing hundreds of global submissions, our template suite simplifies document creation and review and establishes a standardized approach to document development across different disciplines to ensure efficiencies.

  • 規制エキスパートに管理された、規制当局が発出する最新のガイダンスが記載された教本
  • 標準化されたショートカットおよびシンボルを含む、専門分野別のツールバー
  • 進行中のすべての段階で、アクセスできる専的な助言と技術的なサポート

With toolbar features such as automatic formatting and easy table creation/conversion, our users spend approximately 50% less time on document formatting.

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Synchrogenix eCTD Authoring Template Suite
Synchrogenix Writer

Synchrogenix Writer

当社の専門家と技術対応のサービス提供を適用することで、安全性レポートを強化します。

一貫性を保ちながら、大規模ナラティブプロジェクト完了までの時間を短縮します。

  • Use Synchrogenix Writer’s narrative builder features to efficiently manage thousands of narratives to full completion, including review, in a fraction of the time
  • テンプレートは、データベースロック前のデータを使用して開発/テストできるため、データベースロック後のデータを使用して追加の作業を行う必要はありません。
  • ナラティブセット全体のスピード、品質、一貫性を高める
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Engage with Patients via PODIUM

As a complement to our commitment to enhance engagement of patients, caregivers, clinicians, and patient advocates in drug development, we’ve created PODIUM. Using our secure PODIUM platform, sponsors can receive valuable responses throughout the clinical trial process from patient groups within specified therapeutic areas.

  • Inform protocol feasibility by engaging with patients in the study planning/development stage
  • Provide feedback on documents intended for patient use, including informed consent forms and patient summaries of EU Risk Management Plan

Allow patient groups an opportunity to provide comments and assess readability of the plain language summary

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Engage with Patients via PODIUM
Optimize your Medical Communications with BaseCase

Optimize your Medical Communications with BaseCase

Visualize your complex data, optimize medical communications, and create intuitive interactive apps – all without programming. Using Certara’s BaseCase platform, you can develop a range of content that presents key messages and outcomes in a clear and easy-to-understand way.

  • Engage your audience at congress’ & symposiums with dynamic and interactive versions of presentations and publications to maintain audience attention.
  • Educate your customers with relevant and tailored product information such as, clinical trial & plain language summaries, treatment pathways, and epidemiological research.
  • Communicate product value to key opinion leaders and stakeholders to ensure your product gets the right exposure, and to facilitate clear value-based discussions during meetings.
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Justin Savesky
Justin Savesky Sr. Director, Regulatory Science Technology

Justin has been immersed in the technology field for regulatory science for over eight years. He leads Synchrogenix technology commercialization efforts, including product strategy and management.

Gabriella Mangino
Gabriella Mangino Product Manager, Synchrogenix

Gabriella Manginoは、患者ナラティブ制作やプロジェクトリーダーとして製薬会社に長年従事してきました。現在Synchrogenix のプロダクトマネージャーである Manginoは、コマーシャルグループやサービスグループと協力し、当社の技術を駆使したオーサリング機能をサポートするソフトウェアの開発と改善に貢献しています。

Nirpal Virdee
Nirpal Singh Virdee Global Head of Transparency & Disclosure

Nirpal comes with over 18 years of Life Sciences experience. He is a subject matter expert in the Clinical Development, Regulatory Landscape, Transparency and Disclosure space. He is considered an industry thought leader, having globally presented at conferences. He has sat on industry advisory panels. At Synchrogenix , Nirpal is accountable for business development, client management and consulting for technology enabled services.

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