Mail Us

Call Us

(+91) 974 2291 095
(+91) 703 0321 095

Clinical Trials

Clinical Trials

Bioexcel Medical Device Research Organisation offer

Clinical Trials

Feasibility, IRB/IEC Communication, Study Start Up, Monitoring, Auditing & Biostatistics

Bioexcel, a leading Medical Device Research Organization (MDRO), offer Clinical Trial Services, including Study Design and Planning, Patient Recruitment and Retention, and Data Management and Monitoring, are essential for the successful execution of clinical trials for medical devices.

Clinical Trial Services are vital for the successful execution of clinical trials and play a critical role in demonstrating the safety and efficacy of medical devices, which is essential for regulatory approvals and market acceptance.

Study Design and Planning:

  • Customized Study Design: Tailoring the clinical trial design to meet the specific needs and characteristics of the medical device being studied. This includes defining the study objectives, endpoints, and methodologies to ensure the most accurate and informative results.
  • Protocol Development: Creating a comprehensive study protocol that outlines the study’s objectives, patient inclusion and exclusion criteria, study procedures, data collection methods, and statistical analysis plan. This protocol serves as a roadmap for conducting the trial in a standardized and compliant manner.
  • Statistical Analysis Planning: Planning the statistical methods and tools that will be used to analyze the collected data. This is crucial for drawing meaningful conclusions from the trial results and demonstrating the device’s safety and effectiveness.       


Patient Recruitment and Retention:

  • Identification of the Right Patient Populations: Identifying and targeting patient populations that accurately represent the intended users of the medical device. Ensuring that the recruited patients match the demographic and clinical profiles required for the trial.
  • Patient Engagement: Employing strategies to maximize patient recruitment and retention. This includes clear communication, informed consent processes, and measures to ensure patients are motivated to complete the trial.
  • Ethical and Regulatory Compliance: Adhering to ethical principles and regulatory guidelines to protect patient rights and data privacy. Ensuring that the trial is conducted with the highest ethical standards.

Data Management and Monitoring:

  • Data Collection: Implementing robust data collection procedures using advanced tools and technologies. This includes ensuring that data is collected accurately and in a timely manner.
  • Quality Assurance: Implementing quality assurance practices to maintain data accuracy and integrity. This ensures that the data collected is reliable and can be used to support the trial’s outcomes.
  • Secure Data Storage: Prioritizing data security, ensuring that patient and trial data is stored securely and in compliance with data protection regulations.
  • Analysis and Reporting: Employing advanced statistical methods to analyze the collected data and generate comprehensive reports. These reports provide insights into the trial results and are used to demonstrate the safety and effectiveness of the medical device.

Clinical Data Management

When it comes to clinical trial success, data integrity is key. Using Industry- leading electronic data capture (EDC) for data management Bioexcel  have developed  in-house software which is validated according to 21CFR part 11 to  provide high quality data  and security to our clients in a less time & low cost.

Bioexcel provide end to end clinical data management support from eCRF design to final study archival.

  • Electronic data capture
  • eCRF/CRF development
  • Data entry & verification
  • Query generation & resolution
  • Data Monitoring and interim analysis
  • Subject dairy design and development
  • Adverse event, concomitant medication and medical history coding
  • Clinical database creation and auditing
  • Subject randomization plan development

Medical & Scientific writing

Medical writing is a Pivotal part of clinical research and medical device development or regulatory document strengthens the research while an under- developed documents can ruin the efforts of years long research. So it is wise to invest in a team of expert medical writer accurate, compliant and high quality clinical & regulatory document within time.

Bioexcel offer Medical writing spanning individual documents to extensive medical writing program for the Medical Device companies across the globe. Our team consists of qualified medical, pharma, biomedical and Lifesciences member including MBBS, MD, Masters and PhD holders who can prepare error-free documents and reports for regulatory bodies. Our compressive range of service includes the following:

  • Scientific writing
  • Regulatory writing
  • Safety writing
  • Clinical writing

     Quality Assurance:
    Independent and dedicated quality control team for every project, regular oversight/ monitoring of ongoing studies to ensure data integrity, data quality, document management and control

    Routine audit of systems & processes (Internal, vendor, investigators/ sites)

    Due-diligence of every study protocol by QC team for GAP assessment prior to study initiation

Help & FAQ

Frequently Asked Questions

Bioexcel Clinical Trials services are designed to provide a structured and evidence-based approach to assess the safety and effectiveness of your medical device. Our expertise ensures efficient trial design, data collection, and regulatory compliance, expediting your path to market.

Bioexcel customizes study design and planning according to your device's characteristics and regulatory requirements. This includes protocol development, patient recruitment strategies, and statistical analysis planning to ensure robust and compliant trials.

We identify the right patient populations through targeted recruitment strategies. Bioexcel focuses on patient engagement, informed consent, and adherence to ethical and regulatory standards to maximize recruitment and retention.

Bioexcel ensures data collection, quality assurance, secure data storage, analysis, and reporting are conducted with precision. This includes implementing monitoring processes to maintain data integrity and adherence to regulatory standards.

Bioexcel is dedicated to maintaining regulatory compliance throughout clinical trials. We conduct regular assessments, audits, and documentation to ensure that all trials are executed in accordance with ICH-GCP,ISO 14155:2020 and local laws and regulation.