Drug Development Program Management Services

Powerful decisions are driven by insights; insights are gathered from experienced interpretation and the ability to connect the dots between the outcome of one study and the implications for the next. Our experienced team of program managers will guide you through your studies, and the decisions you need to make between studies, to reveal opportunities for your program, maximizing your ROI along your development journey.

Whether your goal is to bring your molecule through commercial approval or to divest at the appropriate point of development, our dedicated team of experts connects you to insights that will maximize the potential of your asset. We see the drug development process as a series of objectives, and manage programs to efficiently meet each of them in a timely fashion.

Engage with experienced scientists who offer a broad range of drug development expertise in efficacy/lead optimization, toxicology, metabolism, CMC, clinical development, as well as regulatory strategy and submissions for any compound or indication. We understand the process holistically, so we can effectively work with you on a high-level strategy. Once initiated, your program manager will communicate program status through collaboration, reports and daily interaction with you.

The drug development journey is riddled with questions. How you answer them determines your unique pathway towards approval.

• Is the therapeutic target or disease pathway validated?
• Can we identify a lead candidate?
• 我们可以制定领导候选人吗？
• Is it safe to give to humans?
• 药物是否在人体临床条件下工作？

我们的计划经理在帮助您回答这些问题方面是有效的，以便在您的期望目的地上有效地进入计划。

我们的计划经理制定了集成策略，以帮助您识别和发展您最佳的领导人候选人。从早期表征和开发批次的制定，到non-GLP screening为了早期识别药理学 - 或毒性相关的问题 - 我们可以帮助您向您的最佳候选人前进。

我们的计划经理无缝地整合了完整的密封阵列非界面服务，包括铅优化，安全药理学, toxicology, pathology,drug metabolism and pharmacokinetics, to assure successful design and conduct of your program — all the way up to and through IND/CTA submittal and/or approval.

通过访问我们的全球临床资源单位，您的计划经理将您的第一次学习提出与监管批准相互作用。每个单位都配备了医生，临床药学家，项目经理，临床研究员和数据管理人员，以确保及时执行您的学习协议。

我们的计划经理团队可帮助您将化合物转化为Phase IIa。我们将您联系到我们的临床和药学工作人员进行学习设计和行为，我们的生物分析员工相关PK / PD参数and to our Central Laboratories for safety monitoring.

Whatever your destination, with a Covance program manager as your partner, you’re set up for success.