Your Patient Focused-Partner for Complex Devices and Combination Therapies
At MEDIcept, every story begins with the patient —
their safety, their privacy, their health. It’s why we chart smarter pathways, prevent risks before they arise, and act fast when challenges appear. Because every step we take brings safer products to the people who need them most. We work with you and for you — but we never stop thinking about them.
Our Services
We are a specialized Global Full Service Clinical Research Organization dedicated to medical devices and combination products.
Our mission is to accelerate innovation while keeping patients at the center of every decision.
From trial design to execution, we deliver expert regulatory guidance, tailored clinical management, and solutions that prioritize patient safety and client relationships that support a successful product lifecycle.
Project Delivery
- Strategic Planning
- Timeline and Budget Oversight
- Proactive Risk Management and Mitigation
- Transparent and Effective Communication
- End-to-End Execution
Clinical Monitoring
- Site Support
- Custom Monitoring Plans
- Site Monitoring
- Proactive Risk Management
- Data Review
Medical Affairs/Medical Writing
- Clinical Development & Strategy
- Protocol and ICF Development
- Medical Monitoring
- IDE and PMA Submission Documents
- Clinical Study/Evaluation Reports
Site Management
- Site Feasibility
- Site Initiation
- Site Oversight and Communication
- Patient Recruitment and Retention
Data Management and Biostatistics
- Case Report Form Development per CDASH Guidelines
- EDC, RTSM, ePRO, Design and Validation
- Data Integrations
- Third Part Data Imports and Reconciliation
- Quality Data Review and Query Management
- Statistical Analysis Plan
- Statistical Programming and Analysis
Quality Assurance
- Clinical Audits: BIMO readiness, FDA Inspection Readiness/GCP Audits
- Quality and Compliance of Processes
- Identification, Management and Resolution of Quality Events
- Oversight and Maintenance of the Quality Management System
Clinical Regulatory
- Clinical Regulatory Strategy
- Regulatory Submissions (e.g. Pre-submission, IND, IDE, NDA, PMA, 510(k), De Novo)
- Clinical Trial Application Submissions
Clinical Safety/Pharmacovigilance
- Development and Implementation of a Safety Monitoring Plan
- Reporting and Analysis of Serious Adverse Events
- Risk Management Strategies to Ensure Participant Safety
- Safety Data Reporting and Documentation for Regulatory Submissions
Functional Services
- Flexible Staffing with Tailored Expertise
- Scalable Solutions
- Full Integration with the Project Team
What Sets our Clinical Services Apart
From kickoff to completion, you work with a stable, cohesive group of clinical experts who understand complex clinical and regulatory landscapes.
Fewer handoffs. Smarter decisions. Better outcomes.
Side-by-Side. End-to-End.
Our strength is in how we show up for our clients: experienced, nimble, and fully committed to getting your innovation to the people who need it. We flex to your needs. Solve problems quickly. And we never forget who it’s all really for.
Why the Right Team Matters
Trial delays aren’t just inconvenient or costly — they’re personal. For patients who need your innovation, a missed milestone could mean a missed window for treatment. We never lose sight of that.