Data plays a critical role in all stages of the drug development lifecycle, aiding in preclinical testing, clinical trials, and regulatory approval. Software is essential for accelerating these processes by efficiently managing and integrating diverse data sources, enabling computational modeling and simulation, providing predictive analytics, enabling efficient review of data, identifying trends, facilitating collaboration, and ensuring regulatory compliance. With Certara’s software tools, researchers can make data-driven decisions, streamline workflows, enhance knowledge sharing, and expedite the overall drug development timeline. The utilization of solutions like Pinnacle 21, Integral, SEND Explorer, or CODEx enhances efficiency, improves success rates, and ultimately contributes to the development of safe and effective drugs in a faster and more cost-effective manner.
Pinnacle 21 Enterprise Software
P21’s clinical data standardization, compliance and automation suite is the next generation cloud platform to optimize your end-to-end trials. Faster study setup and quicker SDTM insights mean earlier decision making. Greater regulatory compliance and data quality maximize your chances of submission approval. And that means lifesaving drugs can be brought to market faster than ever before!
Certara Integral Data Repository
Certara’s compliant repository Integral significantly improves the clinical pharmacology and biostatistics workflow, providing data that is traceable, reproducible, and secure as well as enabling better-informed drug development decisions.
CODEX Clinical Trials Outcomes Database
A.I. powered software CODEX is revolutionizing how clinical trial data can be approached, enabling clinical investigators, trial managers and coordinators to gain new value from internal and external data that can positively influence recruitment strategies, drug target efficacy and overall trial design.
SEND Explorer®
SEND Explorer is a validated, web-based application designed by scientists to provide advanced viewing, data summarization, and visualization capabilities for nonclinical study data. The software also allows companies to make the most of their investment in creating SEND datasets for regulatory submissions by making study data and associated visualizations easily accessible to scientists for internal decision-making.
Repurposed data and advanced analytics can be used to validate a surrogate endpoint. A surrogate endpoint is a substitute endpoint for a clinically meaningful endpoint in clinical trials. It is often used when it is impossible or very time-consuming to measure an intervention’s direct effect on morbidity or mortality. The validity of surrogate endpoints is based on their ability to predict the clinical outcome of interest reliably.1 Surrogacy, or the assessment of a surrogate endpoint as a measure of efficacy and safety for a particular drug class, is generally evaluated through randomized clinical trial (RCT) data.
What factors should be taken into consideration when assessing (or designing) visualizations of nonclinical study data in SEND format? What changes can make a good visualization better, and what pitfalls should be avoided? In this first webinar in a series on “Getting the Most Out of Your SEND Data”, Joyce Zandee, VP of Product Development and SEND Explorer Product Lead at Certara will share recommendations that will help you gauge the effectiveness of data visualizations you are currently using for SEND data (and beyond!) or those you are considering for purchase.
Innovative leader with 20 years of clinical research and healthcare experience, specializing in acquisition, management, and transformation of clinical biospecimen and digital health assessment data. Collaborative creator of tech-enabled solutions for the pharmaceutical industry. Accomplished, analytical director possessing strong interpersonal and communication skills with experience in managing multi-functional teams at both a strategic and tactical level. Key strengths include driving transformational change, strategic planning and execution, spearheading business process improvement initiatives, and building high-performing organizations. Built and introduced countless strategies within R&D to achieve efficiencies and resolve process and application gaps. Experienced in operations oversight and guidance, including resource and financial projections and prioritization.
Having worked in the Pharmaceutical industry her entire career, Joyce has developed a passion for partnering with scientists to design tools which allow them to interact with their study data, to visualize patterns and trends, and to communicate relationships with other scientists. She has been thrilled to see SEND Explorer help organizations embrace a culture of analytic excellence and data-informed decision-making, putting the right tools in the hands of bench scientists and drug development team leaders alike.
Nick Brown is Director, Global Portfolio Leader for Certara.AI; the life sciences-specialized GPT platform. Nick has over 10 years of experience driving AI adoption and customer success across life sciences, federal government and other industries. Prior to Certara, Nick led marketing at Vyasa (now Certara.AI) assisting in the launch and go-to-market strategy for the Layar data platform. He is a graduate of the University of New Hampshire and resides in Andover, MA.
Innovative leader with 20 years of clinical research and healthcare experience, specializing in acquisition, management, and transformation of clinical biospecimen and digital health assessment data. Collaborative creator of tech-enabled solutions for the pharmaceutical industry. Accomplished, analytical director possessing strong interpersonal and communication skills with experience in managing multi-functional teams at both a strategic and tactical level. Key strengths include driving transformational change, strategic planning and execution, spearheading business process improvement initiatives, and building high-performing organizations. Built and introduced countless strategies within R&D to achieve efficiencies and resolve process and application gaps. Experienced in operations oversight and guidance, including resource and financial projections and prioritization.
Having worked in the Pharmaceutical industry her entire career, Joyce has developed a passion for partnering with scientists to design tools which allow them to interact with their study data, to visualize patterns and trends, and to communicate relationships with other scientists. She has been thrilled to see SEND Explorer help organizations embrace a culture of analytic excellence and data-informed decision-making, putting the right tools in the hands of bench scientists and drug development team leaders alike.
Nick Brown is Director, Global Portfolio Leader for Certara.AI; the life sciences-specialized GPT platform. Nick has over 10 years of experience driving AI adoption and customer success across life sciences, federal government and other industries. Prior to Certara, Nick led marketing at Vyasa (now Certara.AI) assisting in the launch and go-to-market strategy for the Layar data platform. He is a graduate of the University of New Hampshire and resides in Andover, MA.