Clinical Trials

Have Questions?

• 什么是FSP？

  FSP代表功能服务提供商，是关于提供定制的全局解决方案，使客户能够有效地管理其临床试验组合。这包括提出质量人员，智能流程和深度技术专业知识，以直接在客户的业务上工作。越来越多的制药和生物技术公司正在转向该模型以减少其开销，并使其运营更加壮大，更高效。CovanceFSPX®是功能服务提供商，您可以通过强大的协作和质量承诺来提供可自定义的解决方案。Learn more about FSP.

• What are Decentralized Clinical Trials, Virtual Clinical and Hybrid Clinical Trials?

  The need to transition from a site-centric approach to a more patient-centric clinical trial model led to innovations that reduce patient burden by reducing the amount of travel needed, allowing more services to be performed at or near the patients’ homes and incorporate new ways of identifying and enrolling trial participants. First called “virtual trials,” meaning investigator sites would play little role, the industry rapidly learned that most trials would involve a hybrid approach, including both traditional and novel technologies. Now this spectrum of trials is usually termed “Decentralized Clinical Trials” or DCT for short. We deliver a patient-centric ecosystem of conveniently located resources all connected by a single technology platform. An example of a DCT model is our solution that includes connecting LabCorp’s U.S.-based Patient Service Centers, global partnerships with reputable retail pharmacies, as well as home health phlebotomy and nursing service providers, with a best-in-class technology platform. We can pair site-based patient recruitment with web-based direct-to-patient outreach.Learn more about DCTs.

• When should Phase IV trials be considered for drug development?

  第IV阶段试验在现实世界中进行“。因此，它们可以补充，在某些情况下更换III阶段试验。如果您的药物用于罕见/孤儿指示，则终原疾病或其中III期试验认为是不道德的，则IV期试验可能对调节剂是优选的。对于晚期细胞和基因治疗，应考虑第IV期试验和随附的长期随访研究。Learn more about Phase IV trials.

• How can Phase IV studies/trials, and Phase IIIb trials be combined to explore new indications?

  探索新的适应症之前批准products requires an appropriate level of safety and efficacy data to be collected to satisfy regulators. Depending upon the target indication, a Phase IV study may suffice to generate the real-world evidence (RWE) needed. However, where more thorough investigation is required, a Phase IIIb clinical trial or a Phase IV trial may be required. Our aim is to maximize efficiency by working with you to determine the most appropriate approach for your product and target indication.

• How does Covance utilize proprietary data to improve clinical study outcomes?

  • Only Covance combines one of the world’s largest sources of de-identified lab results and patient intelligence data with investigator data from the majority of global clinical trials that provide insights to increase efficiencies and effectiveness in clinical drug development.
  • LabCorp Data – using LabCorp’s real-world, de-identified clinical laboratory data on over 150 million patients, we can assess populations who meet your protocol’s eligibility criteria and accurately model the impact that the protocol inclusion/exclusion criteria will have on the patient pool size.
  • Covance Central Labs Data – Covance generates more clinical trial data than anyone else in the world. Our global proprietary data helps us predict future investigator performance and capacity to run multiple studies.
  • Patient Direct – we have access to ~150 million patients and have a rapidly growing database of people who have given us permission to reach out directly to them for participation in clinical studies.Learn more.

• 什么是Covance综合临床药理学溶液？

  Drug development is a complex and challenging pathway to navigate. In today’s environment with ever more complex drugs and drug targets, it is essential to think beyond the four walls of a traditional clinical pharmacology unit in order to optimize early clinical development. An integrated development platform, including the resources, experience, expertise and infrastructure necessary to design and execute early clinical studies is an effective way of mitigating risk. A multidisciplinary team that understands the market and the molecule can devise a regulatory strategy and an early clinical development plan that aims to efficiently determine whether or not a drug candidate should continue to be developed. Effective use of the integrated platform allows for efficient determination of whether or not the drug achieves sufficient levels in the relevant physiologic compartment, whether it interacts with its intended target as anticipated and whether it has any unanticipated or otherwise untoward biological effects. Increasingly, this requires not only strong clinical pharmacology expertise, but also access to biomarker testing and project management staff that can guide a protocol seamlessly from cohorts of normal healthy volunteers in a clinical pharmacology unit to cohorts of patients at multiple investigative sites.了解有关临床药理学的更多信息.

Covance Insights.

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