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
由人工智能驱动的数据匿名化和编辑管理
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. 此外，我们的专家还协助申办方法撰写匿名报告。
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
- 常规和快速临床试验注册和结果披露，包括临床试验方案和统计分析计划的编辑
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.
我们的专家
Evan Richardson 监管服务总监
Trevor Standish产品总监
Evan Richardson 监管服务总监
Trevor Standish产品总监
Evan 是一位经验丰富、以结果为导向的监管事务专业人士，专门致力于 eCTD 提交、FDA 交流和项目管理。凭借超过 15 年的经验，他在向各监管机构成功提交监管文件方面拥有良好的记录。
Trevor Standish 是 Certara 产品总监，在制药、金融和营销等多个行业创建和实施创新软件产品方面拥有十多年的经验。他是一位以客户为中心的团队领导者，在产品 SDLC 管理、UI/UX 设计、人工智能/ML 系统和创新等多个领域拥有专业知识。
Trevor 在管理软件开发生命周期、确定全球产品战略和路线图以及领导团队向敏捷方法过渡方面拥有丰富的经验。他曾在各种行业会议上发表演讲，协助全球销售团队，并在高管圆桌会议上发言。
他曾在 Certara、Concentric、Synchrogenix 和 Fifth Third Bank Corp 等公司任职，展现了出色的领导能力，管理产品组合，并制定了战略性产品路线图。
Evan 是一位经验丰富、以结果为导向的监管事务专业人士，专门致力于 eCTD 提交、FDA 交流和项目管理。凭借超过 15 年的经验，他在向各监管机构成功提交监管文件方面拥有良好的记录。
Trevor Standish 是 Certara 产品总监，在制药、金融和营销等多个行业创建和实施创新软件产品方面拥有十多年的经验。他是一位以客户为中心的团队领导者，在产品 SDLC 管理、UI/UX 设计、人工智能/ML 系统和创新等多个领域拥有专业知识。
Trevor 在管理软件开发生命周期、确定全球产品战略和路线图以及领导团队向敏捷方法过渡方面拥有丰富的经验。他曾在各种行业会议上发表演讲，协助全球销售团队，并在高管圆桌会议上发言。
他曾在 Certara、Concentric、Synchrogenix 和 Fifth Third Bank Corp 等公司任职，展现了出色的领导能力，管理产品组合，并制定了战略性产品路线图。
