Medical Device Clinical Research Organization (CRO) Services
For best results, trust us with your next clinical trial. MEDIcept has a global clinical team supporting clinical trials and post-market studies for device, IVD, and combination products. Our team of experienced clinical operations professionals has the necessary expertise and understanding of the medical industry’s complex clinical trial development and management process to support your clinical trial efforts, from concept inception, through all phases to post-approval. We provide comprehensive medical device CRO services, including clinical operations services, GCP auditing services, and clinical trial regulatory services. We combine firsthand clinical expertise with a deep understanding of current regulatory requirements and client expectations to develop an effective management plan for your clinical trial.
MEDIcept offers a tailored approach to outsourcing clinical trials, from full-service CRO to a la carte functional support.
We provide a wide variety of medical device CRO services, including:
- Clinical Strategy and Submissions
- Trial Start-Up and Management
- Data Management and Biostatistics
- Site Management and Monitoring
- Safety Management
- Medical Writing
- Decentralized Clinical Trials
- Vendor Management and Clinical System Solutions
- Clinical Quality Audits
- Medical Affairs
Clinical Strategy and Submissions
Our clinical team collaborates with regulatory experts to ensure your trial is on target from the start. Our regulatory team ensures that MEDIcept is up to date on all global requirements.
Trial Start-Up and Management
We utilize our site database, established relationships, and experienced selection process to ensure the right investigators are evaluating your product, activation and initiation proceeds efficiently, and that enrollment progresses smoothly.
Site Management and Monitoring
Our expert project managers and monitors provide oversight to ensure site compliance with regulations, protocol, agreements, and IRB requirements.
Data Management and Biostatistics
The MEDIcept data management team provides efficient development and validation of Clinical Systems and ongoing data review for faster database lock. Our expert statisticians are skilled in complex development and methodologies.
Safety Management
The MEDIcept team has a wide range of safety expertise, including safety committee (CEC and DSMB) management.
Medical Writing
We employ PhD/MD-level medical writers well-versed in all types of clinical document creation – from study protocols to clinical study reports.
Other Services
Decentralized Clinical Trials
Telehealth and Participant support, Remote Screening and Enrollment.
Vendor Management and Clinical System Solutions
Full clinical system ecosystem for EDC, eTMF, CTMS, ePRO, IxRS, eConsent, Safety. Strategic partnerships with trusted vendors such as laboratories, Imaging, Central Readers, and Centralized Equipment Providers to support trials.
Clinical Quality Audits
Internal and external sponsor, site, IRB, and vendor audits to assess compliance with regulatory standards and industry expectations; sponsor and site preparation for BIMO audits; CAPA development and implementation.
Medical Affairs
Post market surveillance activities, clinical evaluation reports, literature search and reporting, data extraction and analysis, gap analysis, supporting publication writing.
If you would like to dive deeper into our Clinical Research Organization and how we can help you, click below!
Contact MEDIcept for Medical Device CRO Services
MEDIcept offers a variety of different services to assist you with conducting a successful clinical trial. Fill out the form below to hear back from our team within 1-2 business days.
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