Customized and ready-to-use solutions
The Phoenix™ platform is the industry’s premier software for managing, analyzing and reporting pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) data.
Phoenix Technology Services was established to help our clients leverage Phoenix software, systematize “best practices”, and to take advantage of modeling and simulation trends in both pre-clinical and clinical development. These services, led and implemented by Certara’s professional team of PK/PD software experts, include customized and ready-to-use solutions that span the breadth of the Phoenix platform.
PKAssist for CDISC compliance
PKAssist™ leverages Certara’s team modeling and simulation experts to build configurable software solutions to fill procedural gaps, automate routine processes, and integrate analysis tools with source data systems. 맞춤형 PKAssist 응용 프로그램은 데이터베이스 커넥터처럼 간단할 수 있으며, 규정 준수 데이터 관리 및 CDISC(Clinical Data Interchange Standards Consortium)규정 준수 파일 생성을 포함한 완전한 자동화 분석 및 보고 솔루션과 같이 복잡할 수도 있습니다.
Implementation of Certara Integral
The Phoenix Technology Services team supports your implementation and integration of Certara Integral, a single, validated, 21 CFR Part 11 compliant data repository that streamlines clinical pharmacology workflows.
Integral is a next-generation cloud-based, software as a service (SaaS), validated data and model repository with an intuitive user interface for collecting, managing, and storing multiple types of data sets for analysis, sharing, and reporting of clinical pharmacology, pharmacometric, and all other clinical data.
Validation for Phoenix WinNonlin, NLME and Integral
회사는 미국 FDA의 21 CFR Part 11, 의약품국제조화회의(International Conference on Harmonization of Technical Requirements, ICH)의 기술 요건, EudraLex Annex 11 및 기타 규제 당국의 지침 문서에서 요구하는 대로 소프트웨어 실행에 사용되는 유효성 검사 단계를 수동으로 작성하고 수행하는 데 상당한 시간과 리소스를 투자해야 합니다.
Our validation consulting for Phoenix WinNonlin, NLME , and Integral leverages Certara’s team of validation professionals to meet FDA and OECD compliance requirements.
