Industry standards are continually evolving, creating an environment of rapid change. With change comes challenges. This webinar will identify current eCTD submission challenges, provide applicable solutions and take a look ahead at what’s to come.
Researchers use D360 to query research data efficiently across different data sources and to create visualizations for both small molecules and biological agents. The result? Our industry-leading software D360 enables large pharma to search across the wealth of data and small biotech to keep research nimble and focus R&D expertise on science versus time-consuming data … Continued
Performing individual and population PK/PD analyses requires knowledge and experience with multiple tools to meet desired analysis outcomes within a timely manner. Certara’s Phoenix Platform provides access to the most sophisticated PK/PD workbench tools available today enabling greater ease of use and more efficient pharmacometric workflows, and offers features that support compliance and efficiency. In … Continued
PK/PD data comes from multiple sources, making it challenging to efficiently search, visualize, and analyze your data, and remain compliant for regulatory submissions. Especially with the large volumes of PK/PD data required for today’s complex clinical trials. With Certara’s Integral data and model repository, you’ll streamline your PK/PD workflows and ensure compliance with regulatory requirements … Continued
Have you ever wondered what it would be like to be a Regulatory or Medical Writer in the pharmaceutical industry? Certara’s global regulatory writing team includes PhDs, MDs, PharmDs, scientists, and nurses with backgrounds across all functional areas (Document Quality, CMC, Nonclinical, Clinical, and Regulatory). Our team is growing, and we’re looking for people with … Continued
Physiologically-based pharmacokinetic (PBPK) modeling is being increasingly used in drug development to avoid unnecessary clinical drug–drug interaction (DDI) studies and inform drug labels. Thus, regulatory agencies are recommending more rigorous demonstration of the prediction accuracy of PBPK platforms in their intended use. During this webinar, we present a framework for qualification of the Simcyp Simulator … Continued
Transparency and disclosure efforts are an integral part of medical writing for submissions. Sponsors receive requests from regulators at European Medicines Agency or Health Canada post-submission to share their clinical data publicly but are often overwhelmed with the “who’s and “how’s of the cumbersome and costly efforts to meet these requests. With time working against … Continued
PK/PD data comes from multiple sources, making it challenging to efficiently search, visualize, and analyze your data, and remain compliant for regulatory submissions. Especially with the large volumes of PK/PD data required for today’s complex clinical trials. With Certara’s Integral data and model repository, you’ll streamline your PK/PD workflows and ensure compliance with regulatory requirements … Continued
Performing individual and population PK/PD analyses requires knowledge and experience with multiple tools to meet desired analysis outcomes within a timely manner. With Certara’s Phoenix Platform, you can provide your scientists the tools they need to efficiently perform PK/PD modeling and simulation to support your drug research and development. During this webinar, we’ll be discussing … Continued
Certara’s Synchrogenix™ Writer is a purpose-built writing software for the Pharmaceutical industry that encompasses automation, organization, and collaboration to generate your regulatory submission documents. The software is designed to minimize complexity, help accelerate timelines, and enhance management of large scale medical writing initiatives. Certara understands the effort and complexity that goes into the authoring of … Continued
