New Services Portfolio Supports Users of Certara’s Gold Standard Phoenix Software
PRINCETON, NJ – Feb. 25, 2016 – Certara®, the global biosimulation technology-enabled drug development company, today announced the introduction of Phoenix® Technology Services. These services, led and implemented by Certara’s professional team of biosimulation (modeling and simulation) experts, include customized and ready-to-use solutions that span the breadth of the Phoenix platform. Phoenix is the industry’s premier software platform for managing, analyzing and reporting pharmacokinetic (PK), pharmacodynamic (PD), and toxicokinetic (TK) data. Certara has developed these services to leverage the enormous power of Phoenix by systematizing the ‘best practices’ of its more than 6,000 users and making those practices available to all biopharm organizations.
“Biosimulation has had a profoundly positive impact on drug development and is now expected by global regulators. In fact, 95 percent of the 45 new drugs approved by the US Food and Drug Administration (FDA) in 2015 used the technology to inform label claims. Additionally, the industry trend is toward moving R&D decision-making around drug viability earlier in the development process and using biosimulation to inform that process,” said Certara Chief Executive Officer Edmundo Muniz, MD, PhD. “The Phoenix Technology Services portfolio is being introduced to help our clients leverage Phoenix software to take advantage of these trends in both pre-clinical and clinical development.”
Certara is introducing several new services within the Phoenix Technology Services portfolio:
- Phoenix Workflow Template Services have been developed to optimize R&D productivity, analysis time, standardize calculations and output, minimize quality control checks, and achieve regulatory compliance. Although any Phoenix workflow can be saved as a template, creating reusable templates for handling large amounts of data sets across different studies with varying numbers of treatments, analytes, matrices, and doses requires expertise and significant development time. Templates for discovery PK, pre-clinical and clinical PK are now available ready to use or can be customized for specific workflows and parameters. These pre-packaged templates include serial and sparse sampling for TK studies and CDISC SEND, which will provide sponsors and CROs with more effective knowledge transfer between databases and enable robust protocols for regulatory submission.
- Phoenix プラグイン開発サービス は、母集団 PK 解析用データ作成、First-in-Human アロメトリックスケーリング、CDISC データエクスポート、および投与・治療群無作為化などに対応したツールによって、解析業務および承認申請において要求されるデータの生成や取得を支援し、データの流れを合理化します。これらのプラグインは、ラボラトリー情報管理システム（Laboratory Information Management System、LIMS）、試験プロトコル、化合物管理、投与/治療方法、無作為化、およびCDISCへの申請を含む上流および下流のシステムの双方にPhoenixを統合します。
- PKS Repository Services では、お客様の環境における Phoenix Knowledgebase Server™ (PKS) および PKS Online のインストールを支援することで、21 CFR Part 11 への準拠と Phoenix のバイオシミュレーションデータの完全な監査証跡およびバージョン管理機能による管理を実現したデータ保管環境を構築します。These service solutions cover implementation, migration, integration, and validation support which optimizes regulatory readiness.
- Validation Services for Phoenix WinNonlin®, NLME™, and PKS leverage Certara’s team of in-house validation experts for IQ and OQ documentation, thus eliminating the burden on a client’s internal project team to meet regulatory compliance requirements for computer system validation.
Clients can learn more about these services here and by attending the 2016 Phoenix Roadshow to be held in Basel, Switzerland; Cambridge, UK; Raleigh, NC; San Diego, CA; Chicago, IL; Princeton, NJ; Boston, MA; Shanghai, China; and Osaka and Tokyo, Japan.
Certara is a global biosimulation and regulatory writing company, committed to optimizing drug development decisions. Its clients include hundreds of international biopharmaceutical companies, leading academic institutions, and key regulatory agencies. Certara’s solutions, which span drug discovery through patient care, increase the probability of regulatory and commercial success by using the most scientifically-advanced modeling and simulation technologies and regulatory strategies. For more information, visit www.certara.com.
Ellen Leinfuss, 609-216-9586
Chief Marketing Officer
Lisa Osborne, 206-992-5245
Rana Healthcare Solutions