MEDIcept offers a right-sized, tailored approach to outsourcing clinical trials, from full-service CRO to a la carte functional support.
We provide a wide variety of CRO services, including:
- Clinical Strategy and Submissions
- Trial Start-Up and Management
- Site Management and Monitoring
- Data Management and Biostatistics
- 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 that 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 leverage our website database, well-established connections, and a seasoned selection process to guarantee that proficient investigators assess your product, ensuring a seamless activation and initiation process, and facilitating smooth progression through the enrollment phase.
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.
The MEDIcept team has a wide range of safety expertise, including safety committee (CEC and DSMB) management.
We employ PhD/MD-level medical writers well-versed in all types of clinical document creation – from study protocols to clinical study reports.
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
Explore our comprehensive services encompassing internal and external sponsor, site, IRB, and vendor audits, ensuring adherence to regulatory standards and industry expectations. We specialize in preparing sponsors and sites for BIMO audits, along with the development and implementation of CAPAs, and much more. Your compliance journey starts here.
Post market surveillance activities, clinical evaluation reports, literature search and reporting, data extraction and analysis, gap analysis and supporting publication writing.