Our platform helps you leverage past regulatory data to find evidence-backed answers to your most complex questions.
Quickly piece together the detailed development timelines of relevant products without having to sift through thousands of documents. Visualize the studies that were submitted and the events leading up to regulatory decisions.
The impracticality of sifting through an abundance of scientific knowledge means there's a huge amount of redundancy in drug research and development. Utilizing our platform means you can learn from past development strategies and leverage the work of your peers, including their wins and mistakes.
Many questions on past approvals remain unanswered due to their complexity. The information in the regulatory databases is disconnected, making it impossible to see the full picture. Our technology helps answer the most complex questions to equip you with all the details you need to make a decision.
The information critical to your decisions is hidden in an overload of alerts and newsletters. Regulatory intelligence teams rely on our platform to detect and monitor key topics of interest wherever they arise across the regulatory knowledge bases.
Conduct the most comprehensive regulatory research on any topic of interest. Simply enter your keyword and apply any relevant filters including date ranges, document sections, products, medical conditions, biomarkers, and regulatory designations.
Annotate and extract data points of interest directly from the documents. Leverage search logs, tags, highlights, and more to organize information in your own way.
Using our platform, a regulatory intelligence team was able to search the boxed warning sections of all product labels to discover products with a hepatotoxicity warning. All documents associated with these products were then searched for examples of approved Risk Evaluation and Mitigation Strategies (REMS) implemented to manage these risks.
Not all Diffuse Large B Cell Lymphoma (DLBCL) studies listed in a clinical trial registry supported regulatory decisions. A few clicks on our platform revealed which regulatory-reviewed studies support approvals.
Using the right approach to assess the immunogenicity risk of monoclonal antibodies is important, with past regulator feedback a key consideration. Our platform was used to quickly pinpoint interactions with- and feedback from the regulators on the topic from the review packages of approved monoclonal antibodies.
We help our users quickly find evidence-backed answers to complex regulatory questions by leveraging past data.
Based in Toronto, Canada, Cedience is a team of software engineers, data scientists, and regulatory affairs professionals who share a passion for solving the real challenges in drug development. Our team uses Natural Language Processing (NLP) and Machine Learning (ML) to overcome common issues within the industry.
To support the development of new drugs and biologics, the regulatory authorities publish and maintain a large body of knowledge. This information typically includes webpages, guidance documents, notices, regulations, and product labels. In addition, it often covers product-specific assessments and reviews, correspondence documents, milestone meeting minutes, advisory committee deliberations, information requests, letters, and more.
This level of support and transparency from the regulators is welcomed by the industry but it comes with significant challenges.
Cedience addresses these challenges, bridging knowledge gaps and equipping drug development teams with the information they need to support their decisions.
By automatically centralizing and integrating the regulators’ databases, our SaaS platform enables you to answer complex questions on precedents in minutes instead of days, and generate unique datasets that can augment your regulatory intelligence activities.