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Clinical Research

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.

Why Choose Us

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1

Engineers

Our staff is comprised of biomedical engineers, this allows us to understand both the product and the application at a deeper level than most other CROs. 

This foundational skill allows us to ask better questions, interact at a higher level, and create more value than a standard CRO can provide.

2

Friendly

One important but often overlooked aspect of Clinical Research is the daily interaction between the CRO and the Clinical Research Sites.

This interaction and the ease of it creates can dramatically impact the investigational site’s perspective of your study. Our staff is hired with “clinical relationship skills” in mind. We understand the personal aspect and its importance to overall study success.

3

Budget Friendly

Our highly trained works faster and more efficiently than most CROs. And with our “Fractional Staffing” billing model, unlike other CROs, we are incentivized to work as efficiently as we can to get the tasks accomplished. This aligns our skills, our ethos, and your company goals perfectly.

With Fractional Staffing, we work like we are part of your company (because we are) and our alignment is exactly on your goals. We are paid on results and not on “hours”.

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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

Services

TRIAL MANAGEMENT

Our clinical study management process is where scientific excellence converges with innovative technology to optimize clinical study management. With a steadfast commitment to advancing medical knowledge, our team of biomedical engineers specializes in orchestrating clinical trials with precision.

 

From crafting detailed and well thought out protocols to ensure rigorous study design, to navigating complex regulatory landscapes and upholding the highest ethical standards, we are your partners in driving forward groundbreaking research.

 

Our rigorous data management practices and unwavering commitment to quality assurance guarantee the integrity of your study's outcomes.

 

We are excited to collaborate with you on your project, working together to shape the future of healthcare.

Turn Your Medical Device Idea into Reality

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