Medical Device

Our capabilities and experience in Medical Device Clinical Trials

  • Medical device studies are complex and present unique challenges like:

    Inherent problems in designing medical device trials and selection of endpoints

    Several devices are used by health care professionals, not just end-user patient recipients

    Inability to blind the user that could result in bias issues or other difficulties

    Limitations in comparative trial design

    Potential malfunctions of device mechanisms

    Lack of patient retention due to longer follow-ups like those up to 10 years or until mortality

    Learning curve effect for investigators using new devices

    Operator variability

  • CBCC works closely with its medical advisors to overcome challenges right from the protocol development stage. CBCC employs various strategies for patient recruitment and retention ranging from thorough project specific qualification process engaging with the Principal Investigator early-on in the trial, and careful drafting of inclusion & exclusion criteria, amongst others.

CBCC’s capabilities for compliance, quality and timely execution of Medical device trials

  • Comprehensive services under one roof
  • Team of experienced medical writers, medical monitors and subject matter experts (SMEs) help design robust clinical trial protocols and ensure regulatory compliance, enhanced patient enrollment & retention, and timely completion of the trial with high quality
  • Sound understanding and liaison capabilities with the US, India and other regulatory agencies help obtain timely authorizations
  • Trained and experienced study team assesses feasibility, site qualifications and selection of the right sites to complete the study within pre-defined timelines Efficient site management tracking patient enrollment and monitoring
  • Robust initial and periodic training of the study team on critical aspects of the study
  • Experienced Biometric and report writing team
  • Our unique model provides therapeutic and scientific leadership throughout your program’s lifecycle
  • Our processes are compliant with the USFDA and EU requirements including ISO-14155:11

Site network

  • We follow stringent criteria in selecting study sites to generate high quality data within competitive timelines
  • Established relationships with KOLs (key opinion leaders) and therapeutic networks, experienced in medical device trials in the US and India, allows us to select the ideal sites to ensure that key milestones are met
  • We have >100 sites in our database across India and the US that have experience of conducting clinical trials specifically for medical devices, and the site investigators and staff are trained in current regulatory requirements and experienced in multiple indications
  • We can support patient enrollment in China, Australia and European countries through our partners
  • We have premium site network having prior experience in successful regulatory inspections

CBCC’s experience on Medical Device clinical trials

  • CBCC is the pioneer in quality compliant timely execution of medical device trials in India and the US with more than 15 years of experience
  • From single-center, feasibility trial to multi-center, full service pivotal trials and large scale, post market studies, we have supported large studies of more than 2000 patients
  • Irrespective of your focus area and requirement of simple or complex trial, our team can successfully support and execute end-to-end clinical trial needs
  • Few indications, in which we have supported leading medical companies, are:





    Surgical Wound Care




  • CBCC is experienced in designing and executing of both, early and late phase medical device trials. Our team of Project Mangers, medical writers, regulatory experts, clinicians, SMEs, statisticians, data management and clinical operations experts help you achieve your organizational goals of delivering high quality, efficient therapies for patient care

At CBCC, we support medical device development in multiple ways

  • Early phase trials

    First-in-human or Feasibility studies

    Pilot studies

    Pivotal studies

  • Late phase trials

    Phase 4 trials

    Postmarket clinical follow-up studies

    Pivotal studies

CBCC’s value addition to your medical device development

  • With our scientific, medical and operational expertise, we are well-placed to support all your clinical development programs
  • We can support you to:

    Design scientifically-sound, regulatory-compliant, and medically corroborating clinical trial programs for your regulatory submissions, and ensure continuous support during post-study regulatory inspections

    Get easy access to KOLs in drafting robust protocols and clinical development plans

    Manage projects and facilitate all regulatory activities

    Select the right sites with higher patient pools to expedite patient enrollment and timely execution of project end-points

    Manage multi-country patient enrollment from site selection to close-out

    Generate high quality data at sites through optimum monitoring plans

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