Regulatory Transparency and Disclosure Expertise
Strategy, clinical trial postings, writing, and tech-enabled data anonymization solutions治験データにおける透明性確保と情報開示への要求は高まり続けています。Disclosing clinical trial information and creating transparency of data are key to increasing engagement, trust, and data utility. These, in turn, are expected to spur new products and therapeutic indications, which can lead to a competitive advantage with Clinical Investigators.
Certara provides expertise and technology-enabled services, not only to meet transparency and disclosure requirements, but also to enhance the engagement of study participants, their caregivers and healthcare professionals, and the general public. We address your specific initiatives and risk tolerance while maintaining compliance according to established policy, guidelines, and industry watchdog measures.
As key opinion leaders, Certara’s transparency and disclosure experts speak regularly at major transparency and disclosure events worldwide.
Data anonymization and redaction management powered by artificial intelligence
Our ClinGenuity Redaction Management System (CRMS) artificial intelligence (AI)-powered 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 that they require. In addition, our experts assist sponsors with the authoring of anonymization reports.
We have processed over 6500 reports (15 million pages) to date and completed 65+ European Medicines Agency (EMA) Policy 0070 submissions. Our redaction process supports EMA, Food and Drug Administration (FDA), and Health Canada (HC) redaction and anonymization requirements, with an average of 1 dossier published by HC or EMA each month.
Accurate and efficient clinical trial postings
Using a proven methodology, we’ve supported sponsors with thousands of trial postings to global disclosure databases.
- Reliable and comprehensive assessment of your current compliance with postings on clinicalTrials.gov, clinicaltrialsregister.eu*, EudraCT, and other applicable worldwide registries
- Experienced consulting and project leadership across process components 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 of 31 January 2023, all initial clinical trial applications in the EU/EEA must be submitted through the Clinical Trials Information System (CTIS). However, EU CTR (clinicaltrialsregister.eu) will continue to display information on EudraCT trials. EudraCT remains available for amendments, creation of PIP/Art 46 third country files updating of EudraCT trials’ statuses and relevant submission of results.
Incorporating the patient voice
Engaging with patients and caregivers is a key part of clinical trial recruitment and retainment. Plain language documents can not only help companies meet regulatory requirements but can also increase patient engagement by encouraging health literacy and improving understanding about clinical trials.
Certara’s customizable plain language templates incorporate public health communication best practices to simplify document creation, and deliver easy to understand documents.
Featured Experts
Evan Richardson Director, Regulatory Services
Maryanne Loscalzo Associate Director, Regulatory Operations
Evan Richardson Director, Regulatory Services
Maryanne Loscalzo Associate Director, Regulatory Operations
成果を重視する熟練した薬事申請のプロフェッショナルです。eCTD申請、米国FDA対応、プロジェクトマネジメントを専門としています。本分野において15年以上の経験を有し、世界各国の規制当局に対する承認申請に携わった実績があります。
Maryanneは、eCTD申請、FDAとのコミュニケーション、プロジェクト管理を専門とする、実績重視の薬事専門家です。この分野で 20年以上の経験を有し、さまざまな規制当局への規制当局提出を成功させてきた実績があります。
成果を重視する熟練した薬事申請のプロフェッショナルです。eCTD申請、米国FDA対応、プロジェクトマネジメントを専門としています。本分野において15年以上の経験を有し、世界各国の規制当局に対する承認申請に携わった実績があります。
Maryanneは、eCTD申請、FDAとのコミュニケーション、プロジェクト管理を専門とする、実績重視の薬事専門家です。この分野で 20年以上の経験を有し、さまざまな規制当局への規制当局提出を成功させてきた実績があります。
