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
Certara의 규정 준수 저장소 Integral은 임상 약리학 및 생물통계학 워크플로를 크게 개선하여 추적 및 재현 가능하며 안전한 데이터를 제공할 뿐만 아니라 더 나은 정보에 입각한 신약 개발 의사결정을 내릴 수 있게 합니다.
CODEX Clinical Trials Outcomes Database
A.I. 기반 소프트웨어 CODEx는 임상 시험 데이터에 접근하는 방법을 혁신하여 임상시험 시험자, 임상시험 관리자 및 코디네이터가 모집 전략, 약물 목표 효과 및 전체 임상시험 설계에 긍정적인 영향을 미칠 수 있는 내부 및 외부 데이터로부터 새로운 가치를 얻을 수 있도록 합니다.
SEND Explorer®
SEND Explorer는 비임상 연구 데이터에 대한 고급 보기, 데이터 요약 및 시각화 기능을 제공하기 위해 과학자들이 설계한 검증된 웹 기반 애플리케이션입니다. 또한 이 소프트웨어를 사용하면 과학자들이 내부 의사 결정을 위해 연구 데이터 및 관련 시각화에 쉽게 액세스할 수 있도록 하여 회사가 규제 제출을 위한 SEND 데이터 세트를 만드는 데 투자를 최대한 활용할 수 있습니다.
용도 변경된 데이터 및 고급 분석을 사용하여 대리 평가변수를 검증할 수 있습니다. 대리 평가변수는 임상시험에서 임상적으로 의미 있는 평가변수에 대한 대체 평가변수입니다. 이는 이환율이나 사망률에 대한 개입의 직접적인 영향을 측정하는 것이 불가능하거나 시간이 많이 걸리는 경우에 자주 사용됩니다. 대리 평가변수의 타당성은 관심 있는 임상 결과를 안정적으로 예측할 수 있는 능력을 기반으로 합니다.1 대리 또는 특정 약물 종류에 대한 효능 및 안전성의 척도로서 대리 평가변수의 평가는 일반적으로 무작위 임상시험(RCT) 데이터를 통해 평가됩니다.
SEND 형식의 비임상시험 데이터 시각화를 평가(또는 설계)할 때 어떤 요소를 고려해야 합니까? 좋은 시각화를 더 좋게 만들 수 있는 변경 사항과 피해야 할 함정은 무엇입니까? "Getting the Most Out of Your SEND Data" 시리즈의 첫 번째 웨비나에서 Certara의 제품 개발 부사장이자 SEND Explorer 제품 리드인 Joyce Zandee는 현재 사용 중인 데이터 시각화의 효과를 측정하거나 SEND 데이터(및 그 이상!) 또는 구매를 고려 중인 데이터를 위해 도움이 되는 권장 사항을 공유합니다.
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.
