Clinical Research
100% Medical Device Focused. Budget-Friendly. Best In Industry Service.
- 30+ Studies
- 100% Medical Device Focused
- 100% Customer Satisfaction
Collectively, our team has worked on over 30 clinical studies ranging from Pre-Market, IDE, Pivotal, and Post Market (Registry) studies in the US and around the world. The Disease States we have experience with include: Cardiovascular, Oncology, Neurology, Surgical applications, Epilepsy, Venous Access, Defibrillators, Pacemakers, Bone Cement, Radiology, Radiation Therapy, Ablation, and Dentalproducts.
Budget Friendly
Low Overhead
Fully Remote Workforce (All US-based), keeps our infrastructure price low and we pass on the savings to you.
Scalable
We use a network of trusted partners to provide project scaling when needed. This means you only have to pay for what you need.
Best In-Class Technology
We are preferred partners with a best-inclass EDC system. Our status/relationship brings all the benefits of a world-class EDC system with a lower price point to your project.
Best in Industry Service
Engineer Team
Our clinical project leaders are Medical Device Engineers by degree, and quality and regulatory professionals. This education provides an excellent foundation for the rapid understanding of your product. This facilitates easy communication between your team, our team, and your clinician partners.
Low Turnover
Our team has industry-leading low turnover rates. Your project leader will be there from the start of the project until you cross the finish line.
24/7 Service
We know that clinical studies are unpredictable and emergencies are part of the job, so our project managers are committed to providing assistance 24/7.
Clinical Services by Study Process
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Design
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Execution
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Data Analysis
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Close-Out
Data Management
- eCRF Design
- Develop Requirements
- Resolve all Queries
- Database Lock & Archive
- Post-Production Changes
- Data Review & Cleaning
- Data Entry
- Database Development
- Database Programming
- Database User Training
- Data Management Plan
- Centralized Data Monitoring Plan
Analysis
- Clinical Study Design
- Protocol Development
- Randomization Schedule
- SAP Development
- Tables, Figures, Listings
- Interim Analyses
- Annual Report Analysis
- DSMB Reports
- Statistical Results
- Data Interpretation
- Clinical Study Reports
- Publications
- Regulatory Meetings
Study Management
- Protocol
- Informed Consent
- Investigator Selection
- Contract & Budget
- Negotiation
- Site Initiation Visits
- Subject Enrollment
- Data Collection
- Interim Monitoring Visits
- DSMB/CEC Management
- TMF Management
- Site Payments
- Close-Out Visits
- Final Device
- Accountability
- Audit Preparation
TRIAL MANAGEMENT
Driving value by innovating the way you manage trials
Our FSP programs successfully deliver various functional trial management solutions, identifying and staffing key leadership roles with global project management experience. We provide a flexible and dedicated workforce, seamlessly integrated into our client’s teams to execute the trial management of their trial portfolio.
Within a trial management FSP program, innovations in technology and analytics enable key tasks and activities to be completed centrally, such as removing administrative burden to low cost centralized locations and rethinking traditional trial management tasks, offering incremental improvements to derive more value
Clinical Monitoring
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Data Management
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Biostatistics
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Medical Writing
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Lifecycle Safety
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Regulatory Affairs
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry’s standard dummy text ever since the 1500s, when an unknown printer took a galley of type and scrambled it to make a type specimen book. It has survived not only five centuries, but also the leap into electronic typesetting, remaining essentially unchanged.
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