IPP - DRUG DEVELOPMENT SUPPORT FOR CTEP

“CTEP的药物开发支持”合同为癌症治疗评估计划(CTEP)管理事务部(RAB)和研究药物处(IDB)提供一系列支持服务。该合同的主要目标是提供技术和行政基础设施，以支持FDA监管赞助商的合规，履行药物合作者协议的条款，并协助临床试验的征集。支持任务包括：1)准备、跟踪、提交和分发与CTEP药物开发相关的文件和FDA提交的文件；2)跟踪包括生物标记物在内的研究抗癌药物的信息；3)支持安全监测和不良事件报告；4)支持合作者协议活动；5)为研究试剂开发和监管活动提供一般技术和行政支持。

The “Drug Development Support for the CTEP” contract provides support to the Cancer Therapy Evaluation Program (CTEP) Regulatory Affairs Branch (RAB) and Investigational Drug Branch (IDB) for a spectrum of support services. The main objective of this contract is to provide a technical and administrative infrastructure to support FDA regulatory sponsor compliance, to fulfill the terms of pharmaceutical collaborator agreements and to assist in the solicitation of clinical trials. The support tasks include: 1) the preparation, tracking, submission and distribution of CTEP drug development related documents and FDA submissions; 2) tracking information regarding investigational anti-cancer agents including biomarkers; 3) support safety monitoring and adverse event reporting; 4) support collaborator agreement activities and 5) provide general technical and administrative support for investigational agent development and regulatory activities.