Clinical & Market Approval

Trials for devices, in vitro diagnostics and combination products.

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Strategic, collaborative support

Comprehensive data collection and analysis

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:

  • What are the right endpoints to collect and report to best support the objectives of my trial?
  • How can I identify and qualify preferred sites to ensure enrollment and study compliance success?
  • What is the best patient population and how can I motivate patients to participate in my trial?
Put your clinical strategy into action with support for pilot/feasibility, pivotal and post-market device trials. Your trial is seamlessly conducted - from study design consultation and protocol all the way through to the final analysis and summary report for regulatory submission. 
Advance smartly with a dedicated clinical team that specializes in device trials. Your study is driven with strong science and deep care area experience to deliver a patient-centric trial. Plus, unique data sources are leveraged to inform and accelerate the recruitment of high-performing investigators and patient populations. 
With innovative approaches from traditional to decentralized (virtual) trials, rest assured you will experience an expertly executed clinical study tailored to your specific clinical areas.

Customized trials to fit your clinical discipline:

  • Study Conduct

    Every clinical program starts with a strategy and a deep collaboration between you and your Program Manager, an experienced resource that stays with you for the duration of your program. Your trial will be designed to fit your clinical goals – driven with a proven process that advances you through from start to finish.

    Comprehensive solutions are available to drive your clinical trial

    • Clinical Strategy
    • Clinical Study
    • Design Protocol Development
    • Clinical Study Operations
    • Site Recruitment and Qualification
    • Patient Recruitment & Retention
    • Site Management
    • Site Monitoring Services
    • Database Development & Management
    • Data Management
    • Biostatistics Consulting
    • Data Monitoring Committee (DMC)
    • Management Data Safety Monitoring Board (DSMB)
    • Management Clinical Events Committee (CEC)
    • Management
    • Clinical Compliance/Auditing
    • Statistical Design & Analysis
    • Analytical Validation Studies

    Are you developing a combination product or in vitro diagnostic (IVD) test?

    Programs to develop an in vitro diagnostic or combination product can be complex – due to having different regulatory bodies and development pathways to follow. Streamline your effort with a single partner that can help coordinate it all with access to our enterprise portfolio of solutions:

    • Drug development  - enabling you to synchronize device and drug/biologic development.
    • Diagnostic testing from Labcorp, our parent company - leverage our testing laboratories for your IVD trials. 

    By combining the power of our organization’s vast capabilities, you will find new ways to optimize and unify your plan.

  • Data-Driven Decisions

    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, central labs global 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 with Xcellerate® 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.

    • Protocol design tool – 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.
    • Patient intelligence – enables you to design a more patient centric trial to improve patient recruitment and retention.
    • 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 Design

    Clinical trial options for virtual ingenuity

    Looking for a patient-centric approach to running your study that brings the trial to the patient instead of the patient to the trial? New innovations, technology and services are paving the way for augmenting medical device trials with mobile devices and a digital means for conducting trials. Consider incorporating a variety of 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)
    • Site-to-Patient 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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