Clinical & Market Approval

Trials for devices, in vitro diagnostics and combination products.

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Strategic, collaborative support

综合数据收集和分析

Patient-centric technology solutions

Once you receive approval to advance your device to the clinical stage, you will have many new questions to address, such as:

  • 收集和报告最好支持我的审判目标是什么?
  • How can I identify and qualify preferred sites to ensure enrollment and study compliance success?
  • 什么是最好的患者人口,如何激励患者参加我的审判?
将您的临床战略与支持试点/可行性,关键和市场后设备试验的行动。您的试验无缝进行 - 从研究设计咨询和协议一直到监管提交的最终分析和摘要报告。使用专门从事设备试验的专用临床团队进行巧妙地推进。您的研究是以强烈的科学和深层护理区域的推动,以提供以患者为中心的审判。此外,独特的数据来源被利用,以通知并加速招聘高性能调查员和患者人口。亚博全站官网通过传统的传统方法来分散(虚拟)试验,请放心,您将体验到您的特定临床区域定制的专业执行的临床研究。

定制试验以适应您的临床学科:

  • 学习行为

    每个临床计划都以策略和您和您的计划经理之间的策略和深刻的合作,这是一个经验丰富的资源,以便在您的计划期间与您保持一致。您的审判将旨在符合您的临床目标 - 通过经过验证的流程来驱动,从开始完成后进入您。

    Comprehensive solutions are available to drive your clinical trial

    • Clinical Strategy
    • Clinical Study
    • Design Protocol Development
    • Clinical Study Operations
    • 网站招聘和资格
    • Patient Recruitment & Retention
    • Site Management
    • Site Monitoring Services
    • Database Development & Management
    • 数据管理
    • 生物统计学咨询
    • 数据监测委员会(DMC)
    • 管理Data Safety Monitoring Board (DSMB)
    • 管理Clinical Events Committee (CEC)
    • 管理
    • Clinical Compliance/Auditing
    • Statistical Design & Analysis
    • Analytical Validation Studies

    Are you developing a combination product orin vitrodiagnostic (IVD) test?

    Programs to develop anin vitro诊断或组合产品可以复杂 - 由于具有不同的监管机构和发展途径。使用单个合作伙伴简化您的努力,可以帮助协调我们的企业的解决方案组合:

    • Drug development from Covance- 使您能够同步设备和药物/生物发展。
    • Labcorp的诊断测试, our parent company - leverage our testing laboratories for your IVD trials.

    通过结合我们组织的大量能力的力量,您将找到新的方法来优化和统一您的计划。

    Covance Medical Device and Diagnostics -  by the numbers

  • 数据驱动的决策

    Your trial is driven by an unrivalled, powerful combination of data sources to inform decision-making. With intelligent recruitment, you can minimize study costs, speed time to market and increase forecasting accuracy. Gain timely, real-world LabCorp diagnostic lab result data, Covance Global Central Labs investigator performance data and patient intelligence input that provides unique insights – putting you on the right track to enjoy faster patient enrollment and enhanced patient retention.

    When your trial is underway, you are fully armed withXcellate.® for a comprehensive risk-based quality management (RBQM) approach and enhanced visibility into your trial performance. You’ll enjoy near real-time holistic insights, allowing your study team to make informed decisions and proactively mitigate issues that may come up. This means you can reduce study risk, ensure data quality and gain operational insights – keeping your patients safe and helping you get your medical device to market successfully.

    • 协议设计工具– accurately assess the number of people that meet your study criteria, model the data to
      maximize the available patient pool and pinpoint geographic clusters of people who fit the defined eligibility criteria.
    • 患者智力- 使您可以设计更耐用的以患者为中心的审判,以改善患者的招聘和保留。
    • Site list tool– inform data-driven decisions that can optimize patient enrollment, avoid costs associated with poor and non-performing sites and cut down on the unnecessary inclusion of additional countries.
    • Recruitment modeling and forecasting– improves enrollment predictability and mitigates risk throughout a study to meet your patient recruitment and delivery milestones.
    • Spatial cluster analysis– guides your selection of sites based on location of eligible patient clusters to improve study planning and accelerate patient enrollment.
    • Patient direct– a direct-to-consumer recruitment model that can supplement your investigators’ databases.
  • Decentralized Designs

    Clinical trial options for virtual ingenuity

    寻找一种以患者为中心的方法来运行您的学习,将审判与患者而不是患者进行审判?新的创新,技术和服务正在为使用移动设备的增强医疗设备试验和用于进行试验的数字手段来铺平道路。考虑纳入各种各样的decentralized, yet more connected, methods that take the burden off the patient and sites to accelerate recruitment and increase the likelihood of keeping your patient on your trial for its duration.

    Talk to us about incorporating the following remote possibilities into your next medical device trial:

    • Telehealth
    • Mobile-health Nursing
    • Mobile-health Phlebotomist
    • Remote Monitoring
    • Patient Service Center
    • Connected Device Solutions
    • ePro/eCOA/eDiar
    • eClinical Applications
    • eSource (EDC Integration)
    • Remote Source Document Verification (SDV)
    • Connected Device Solution
    • HER/EMR Connectivity
    • SAE Trackin
    • Remote Site Qualification
    • Interactive Response Technology (IRT) Integration
    • eDrug Accountability (IRT) Integration
    • Direct-to-Patient Investigational Medicine Products (IMP)
    • 站点到患者的IMP
  • Experience You Can Count On

    Confidently get your device to market with our team of specialists deeply experienced in strategic design and all aspects of conducting clinical trials for the medical device industry. In the past five years alone, our device team has collaborated on more than 500 clinical studies with more than 3,000 investigator sites, reaching over 110,000 patients worldwide.*

    Together with our parent company, LabCorp, your trial will be matched with high-performing investigators with optimal patient pools for a successful trial. Here’s a quick glance at the numbers for 2020:

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