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临床试验

Let's partner to deliver patient-centric, innovative solutions that redefine the possibility of drug development. Learn how to accelerate patient recruitment and optimize protocol design while reducing patient burden and increasing retention.

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患者情报:在COVID-19时代设计临床试验

在COVID-19时代,患者对新疫苗和新疗法的上市迫不及待。这就是为什么即使在这些充满挑战的时代,科文斯仍然比以往任何时候都更加专注于了解患者对参与临床试验的看法。 As social distancing has become the new normal, the need to understand changes in preferences associated with interest in trial participation should be taken into account when developing protocols.

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COVID-19(冠状病毒)大流行期间的NASH临床研发

The COVID-19 pandemic has brought unprecedented challenges in clinical development. Travel restrictions, social distancing and the fear of contracting the disease are impeding conventional trial conduct. Typically, routine patient and monitoring visits to healthcare facilities are now the exception, study coordinators and site staff have increased demands on their time and, in some cases, layoffs have rendered some sites incapable of continuing as usual. To help keep patients safe and allow trials to progress, regulatory authorities worldwide have issued guidance for industry, investigators and institutional review boards.

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LabCorp Accelerates Adoption of Decentralized Clinical Trials, Expands Technology Ecosystem Through Alliance with Medable

LabCorp, a leading global life sciences company that is deeply integrated in guiding patient care, today announced that Covance, its drug development business, is expanding its technology ecosystem to accelerate the adoption of decentralized clinical trials, often referred to as hybrid and virtual clinical trials. Covance is expanding its decentralized trials technology ecosystem through an alliance with Medable, a leading software provider for digital clinical trials.

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By the Numbers

During the last 5 years, Covance Clinical Development Services has worked on:

3,800

研究

64,000

Investigator Studies

660,000

患者

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Decentralized Clinical Trials – Best Practices for Designing a Flexible, Resilient Protocol

As drug development sponsors are incorporating patient-centric elements into their traditional clinical trial designs, there are several factors to consider during the study planning phase. Whether using telemedicine, mobile nursing services, laboratory support, patient service centers, investigational product management or a combination of these elements, it is important to develop an operational strategy that allows for flexibility and accounts for complete oversight of each connection point between patients, service providers and the sponsor.

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Have Questions?

  • What is an FSP?

    FSP stands for functional service provider and is about delivering customized global solutions that enable clients to efficiently manage their clinical trial portfolio. This includes putting quality people, intelligent processes, and deep technical expertise in place to work directly on a client’s business. An increasing number of pharmaceutical and biotech companies are turning toward this model to decrease their overhead and make their operations leaner and more efficient. Covance FSPx® is the functional service provider you can rely on to deliver customizable solutions through strong collaboration and commitment to quality. 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?

    Phase IV trials are conducted “in the real world.” As such, they can complement, and in certain circumstances, replace Phase III trials. If your drug is for a rare/orphan indication, a life-critical condition or where a Phase III trial would be considered unethical, a Phase IV trial may be preferable for regulators. For advanced cell and gene therapies, Phase IV trials and accompanying long-term follow-up studies should be considered. Learn more about Phase IV trials.

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

    Exploring new indications for previously approved 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. 了解更多

  • What is the Covance Integrated Clinical Pharmacology Solution?

    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. Learn more about clinical pharmacology.

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