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:
Patient Recruitment and Retention:
Data Management and Monitoring:
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.
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:
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
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.
TO BREAK THE BARRIERS OF TRADITIONAL CLINICAL INVESTIGATION FOR MEDICAL DEVICE INDUSTRY
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