Certara delivers customized solutions to meet evolving global transparency requirements. From accurate clinical trial postings to AI-powered data anonymization, we help you navigate the complex regulatory landscape with precision and ease. By incorporating patient-centric approaches and leveraging advanced technology, we ensure compliance while enhancing trust and engagement with all stakeholders.
Clinical Disclosure
Advanced data privacy and compliance solutions for regulatory submissions
Learn more about clinical disclosure
Explore best practices for transparency and disclosure in clinical trials and advance your compliance goals.
Enhance engagement, compliance, and trust
AI-driven redaction services
We combine cutting-edge AI technology with expert oversight to streamline the redaction process while ensuring patient privacy.
Global regulatory expertise
Leverage our experienced team to navigate complex regulations across global jurisdictions.
Custom risk assessments
We utilize risk-based questionnaires and multi-system assessments to optimize the balance between utility and risk.
Proven track
record
With over 15 million report pages redacted and 40+ sponsors annually, we deliver trusted results.
AI-powered anonymization & redaction solutions
Our advanced, AI-driven anonymization and redaction services combine TrialAssure’s cutting-edge technology with expert review to protect sensitive patient data while ensuring compliance with rigorous regulatory standards. Designed to handle the complexities of modern clinical trials, our adaptive and precise anonymization and redaction solutions empower you to focus on advancing groundbreaking medical research without compromising confidentiality.
Certara: Innovating clinical trial transparency
Our offerings
Clinical protocol registration made simple
Effortlessly register your clinical protocols and comply with global requirements across various registries, including: ClinicalTrials.gov, EudraCT, now transitioned to CTIS and other worldwide registries.
Streamlined CTA submissions
Ensure smooth Clinical Trial Application submissions with our expertise in handling the new CTIS platform for European trials.
Transparent and accurate results reporting
Our services support clinical study results postings across leading registries including posting on: ClinicalTrials.gov, EudraCT/CTIS, and additional global registries.
Regulatory Redaction & Anonymization
- Redaction of CTA documents for Clinical Trial Information System (CTIS) submissions.
- Dossier redaction and anonymization compliant with EMA Policy 0070 and Health Canada PRCI standards.
Lay Language Documents
Lay protocol synopses (LPS), Lay summaries of results (LLS), Informed consent forms (ICF), Individual return of results
Meet our experts
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Experts
Evan Richardson
Senior Director, Regulatory Operations and Clinical Disclosure
Evan's experience in the pharmaceutical industry includes drugs, biologics, and medical devices. He has worked for both service providers and in industry over the past 18 years. In his current role, Evan leads a global team supporting Certara’s clients in meeting regulatory requirements for the disclosure of clinical data.
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Experts
Anaya Rehman
Senior Transparency Specialist
Anaya has more than 10 years of experience in healthcare, academic research, and the pharma industry. She provides technical leadership and subject matter expertise for the clinical trial transparency and disclosure team at Certara.
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Experts
Honz Slipka
Senior Transparency Specialist
With a research background in neuroscience, and experience in health information technology, Honz has a thorough understanding of data analysis, regulatory standards, and best practices in the field of clinical data privacy.
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Experts
Michele Andrush
Associate Director of Disclosure Services
Michele specializes in working with Certara’s valued partners to improve all Disclosure services. She is passionate about helping sponsors exceed new compliance regulations and benefit from transparency in the drug development process.
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Our team of seasoned professionals is ready to support your clinical trial transparency and disclosure needs. Whether you’re navigating global regulatory requirements or looking to enhance patient engagement, we’re here to help you succeed.
Over 6500 reports processed with precision.
Trusted partner for 65+ EMA Policy 0070 submissions.
AI-powered tools for efficient data anonymization.
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Your questions answered
What is clinical trial transparency and disclosure?
Clinical trial transparency and disclosure refer to the processes of sharing trial data to meet regulatory requirements, foster trust, and enhance engagement.
How does Certara support compliance?
Certara provides tailored solutions, including data anonymization, clinical trial postings, and plain language documents, to ensure compliance with global standards.
What technologies does Certara use?
Our AI-driven ClinGenuity Redaction Management System streamlines redaction and anonymization processes with expert oversight.
