Providing solutions that keep the pain out of compliance
Pharmaceutical companies and other sponsors of clinical trials are under increased pressure to disclose data and documents in accordance with regulations and requirements that include the European Medicines Agency (EMA) Policy 0070, European Union Clinical Trial Regulation (EU CTR) and Health Canada Public Release of Clinical Information (PRCI). As the demand for increased transparency and disclosure continues to grow, so does the need for more advanced anonymization and redaction solutions to meet changing regulations and the needs of patients, study participants, and their caregivers.
As the leading technology and services provider in clinical trial transparency and disclosure, Certara, provides technology-enabled advanced anonymization and redaction services for posting regulatory documents and clinical trial data in the public domain. These services include compliance assessment, consulting and project leadership, and remediation planning.
Certara has been at the forefront of the transparency movement since the inception of EMA Policy 0043 including the support of proactive report disclosure by large pharma before regulations were introduced. Certara was the first to provide an artificial intelligence (AI)-enabled redaction technology solution with built in patient privacy algorithms to the marketplace.
“Thank you so much for providing all the documents required for the XXX NDS PRCI project, including the proposed redaction documents for personal information and confidential business information, anonymization report, and CBI control sheet.”
– Regulatory Director, Global biotechnology company
Data anonymization and redaction management powered by artificial intelligence
The Clingenuity Redaction Management System (CRMS) artificial intelligence-powered anonymization and redaction solution is supported by expert reviewers who ensure that trials with specific challenges, such as small populations or rare diseases, receive the customized approach they require. In addition, our experts assist sponsors with the authoring of anonymization reports.
Features of our anonymization process include:
- Validated and 21 CFR Part 11 compliant system
- Powered by natural language processing (NLP)
- Risk based questionnaire to set individual risk thresholds
- Multi-system generated risk assessment for optimal balance between risk and utility
- Reusable templates
- Systematized approach to quality control review
- Customizable publishing formats
Using the CRMS, we have redacted over 15 million report pages to date and work with 40+ sponsors annually.
Technology paired with in-house Transparency Specialists
Recognizing the importance of optimizing the utility of your clinical data while still maintaining patient privacy, we employ our global team of in-house Transparency specialists to assure your compliance with the evolving regulatory requirements for quantitative risk and advanced anonymization of trial data.
From clear-cut to more challenging thresholds and determinations based on population size and disease, we work with your team to come up with the optimal approach.
Strategic consulting services
Our transparency and disclosure experts address sponsor-specific initiatives and risk tolerance while maintaining compliance according to established agency guidelines and industry watchdog measures.
- Experienced consulting and project leadership to ensure that transparency requirements are met in the most optimal manner
- Preparation of remediation plans and creation of future robust processes, including policies, Standard Operating Procedures, and Work Instructions
- Routine and expedited clinical trial registration and disclosure of results, including redaction of clinical trial protocols and statistical analysis plans
As key opinion leaders, our anonymization and redaction experts speak regularly at major transparency and disclosure events worldwide.
CBI/CCI identification
Preparing anonymized and redacted reports for regulatory agency submissions that remove Company Business Information (CBI) for Health Canada and Commercially Confidential Information (CCI) for EMA presents a major challenge for sponsors.
The ability to identify the intellectual property that sponsors want to protect versus what is already in the public domain is an extensive activity that calls on finite legal and regulatory resources within sponsor organizations. We address this for our sponsors by offering a unique consulting team that has expertise with both regulatory and legal backgrounds.
Our team of experts are able to:
- Simplify the CCI/CBI identification process by conducting a detailed informative session for your team on the industry best practices for CCI/CBI
- Provide consultation on the identified CCI/CBI based on our extensive experience
- Annotate the reports and develop a justification table by utilizing our automated system to make your submission regulator-ready
Our process has saved sponsors a great deal of frustration. Additionally, sponsors have seen a reduction in agency review of their CBI/CCI.
当社のエキスパート
Evan Richardson Senior Director, Transparency and Disclosure, Certara
Trevor Standish Product Director
Evan Richardson Senior Director, Transparency and Disclosure, Certara
Trevor Standish Product Director
Evan Richardson began his career in the pharmaceutical industry 18 years ago, and today he is the Senior Director of Transparency and Disclosure services at Certara. His experience includes drugs, biologics, and medical devices and he has worked for both service providers and in industry across organizations of all sizes. Evan has worn many hats throughout his career, including roles in regulatory affairs, regulatory operations, quality management, and project management. In his current role, Evan leads a global team of subject matter experts supporting Certara’s clients in meeting their regulatory requirements for the disclosure of clinical data.
Trevor Standishは、製薬、金融、マーケティングなどさまざまな業界で革新的なソフトウェア製品の開発・導入に10年以上の経験を持つプロダクト・ディレクターです。製品SDLC管理、UI/UXデザイン、AI/MLシステム、イノベーションなど様々な分野に精通する顧客重視のチームリーダーす。
Trevorは、ソフトウェア開発ライフサイクルの管理、グローバル製品戦略とロードマップの定義、アジャイル手法への移行におけるチームのリーダーとして豊富な経験を有しています。さまざまな業界会議で発表し、グローバル営業チームを支援してきました。
サターラでは強力なリーダーシップを発揮し、製品ポートフォリオを管理し、戦略的製品ロードマップを定義しました。
Evan Richardson began his career in the pharmaceutical industry 18 years ago, and today he is the Senior Director of Transparency and Disclosure services at Certara. His experience includes drugs, biologics, and medical devices and he has worked for both service providers and in industry across organizations of all sizes. Evan has worn many hats throughout his career, including roles in regulatory affairs, regulatory operations, quality management, and project management. In his current role, Evan leads a global team of subject matter experts supporting Certara’s clients in meeting their regulatory requirements for the disclosure of clinical data.
Trevor Standishは、製薬、金融、マーケティングなどさまざまな業界で革新的なソフトウェア製品の開発・導入に10年以上の経験を持つプロダクト・ディレクターです。製品SDLC管理、UI/UXデザイン、AI/MLシステム、イノベーションなど様々な分野に精通する顧客重視のチームリーダーす。
Trevorは、ソフトウェア開発ライフサイクルの管理、グローバル製品戦略とロードマップの定義、アジャイル手法への移行におけるチームのリーダーとして豊富な経験を有しています。さまざまな業界会議で発表し、グローバル営業チームを支援してきました。
サターラでは強力なリーダーシップを発揮し、製品ポートフォリオを管理し、戦略的製品ロードマップを定義しました。
