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)
Medicept Inc.
Services
Outsourced clinical research organization services from full-service trial management to modular functional support for device, in vitro diagnostic, and combination products.
Development of clinical strategies, feasibility and first-in-human studies, and study designs intended to support regulatory submissions and interactions.
Site selection, activation, monitoring, and enrollment management to ensure sites comply with protocol and regulatory requirements.
Clinical systems development, ongoing data review, validation, and statistical support for study analysis and database lock.
Safety program development and management including oversight of independent committees such as DSMBs and clinical event committees.
Authoring of clinical documents from protocols to clinical study reports by experienced medical writers.
Outsourced clinical research organization services from full-service trial management to modular functional support for device, in vitro diagnostic, and combination products.
Development of clinical strategies, feasibility and first-in-human studies, and study designs intended to support regulatory submissions and interactions.
Site selection, activation, monitoring, and enrollment management to ensure sites comply with protocol and regulatory requirements.
Clinical systems development, ongoing data review, validation, and statistical support for study analysis and database lock.
Safety program development and management including oversight of independent committees such as DSMBs and clinical event committees.
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)