Clinical Research

100% Medical Device Focused. Budget-Friendly. Best In Industry Service.

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  • 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 Dental products.

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 in-class EDC system. Our status/relationship brings all the benefits of a world-class EDC system with a lower price point to your project.

Learn More About EDC Tool

Best in Industry Service

Strong Technically Knowledgable Team

Our clinical project leaders are Medical Device Engineers by degree, as well as quality and regulatory professionals. This education and experience 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.

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Clinical Services by Study Process

  • Design
  • Execution
  • Data Analysis
  • Close-Out
Data Management
  • eCRF Design
  • Develop Requirements
  • Resolve all Queries
  • Database Lock & Archive
  • During Study Database 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

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

When it comes to clinical monitoring, we’ve got you covered. Our experienced team members will ensure that your site research activities are properly recorded, conducted, and reported according to the study protocol, all while following the necessary regulatory requirements.

Data Management

Data management is a key part of the clinical trial process. A data management program should be in place to help with the process of gathering, managing, and analyzing data. We utilize Viedoc as our preferred data managment program to provide you an all-in-one solution.

Biostatistics

Our team will help create a straightforward statistical analysis plan that will lessen the length of the project and keep things on track. Our technical knowledge and expertise are essential in interpreting the data gathered from clinical trials. We are much more cost-effective than an in-house biostatistician.

Medical Writing

We provide medical writing support for the all stages of product development. We offer flexible and efficient processes for any size project. We apply best practices for content, format, and style to meet global technical and regulatory requirements.

Lifecycle Safety

 

Regulatory Affairs

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