Medicept Inc.
MEDIcept is a company dedicated to providing trusted solutions in clinical operations, healthcare compliance, cybersecurity risk management, and clinical research organization services. With extensive expertise and a focus on regulatory compliance, risk mitigation, and clinical trial support, MEDIcept aims to help medical device and healthcare organizations succeed in bringing innovative products to market while ensuring safety, efficacy, and regulatory adherence.
Industries
Nr. of Employees
small (1-50)
Services
Full-service and modular clinical CRO services
Outsourced clinical research organization services from full-service trial management to modular functional support for device, in vitro diagnostic, and combination products.
Clinical strategy and regulatory submission support
Development of clinical strategies, feasibility and first-in-human studies, and study designs intended to support regulatory submissions and interactions.
Trial start-up, site management and monitoring
Site selection, activation, monitoring, and enrollment management to ensure sites comply with protocol and regulatory requirements.
Data management and biostatistics
Clinical systems development, ongoing data review, validation, and statistical support for study analysis and database lock.
Safety management and committee support
Safety program development and management including oversight of independent committees such as DSMBs and clinical event committees.
Medical writing
Authoring of clinical documents from protocols to clinical study reports by experienced medical writers.
Full-service and modular clinical CRO services
Outsourced clinical research organization services from full-service trial management to modular functional support for device, in vitro diagnostic, and combination products.
Clinical strategy and regulatory submission support
Development of clinical strategies, feasibility and first-in-human studies, and study designs intended to support regulatory submissions and interactions.
Trial start-up, site management and monitoring
Site selection, activation, monitoring, and enrollment management to ensure sites comply with protocol and regulatory requirements.
Data management and biostatistics
Clinical systems development, ongoing data review, validation, and statistical support for study analysis and database lock.
Safety management and committee support
Safety program development and management including oversight of independent committees such as DSMBs and clinical event committees.
Medical writing
Authoring of clinical documents from protocols to clinical study reports by experienced medical writers.
Expertise Areas
- Clinical trial management
- Clinical strategy and regulatory submissions
- Decentralized clinical trials
- Clinical data management and biostatistics
Key Technologies
- Electronic data capture (EDC)
- eTMF and clinical trial management systems (CTMS)
- ePRO and electronic consent systems
- Interactive response systems (IxRS)