Clinical Research Services

The Integra Group offers clinical research services that support all phases of clinical studies from inception of your investigational product through post-market approval. With a clinical affairs department made up of industry experts in roles such as medical research managers, medical research associates, database developers, data managers, regional monitors and field clinical engineers we are positioned to guide you through your medical device clinical trials. Our experience and knowledge managing an supporting US and OUS clinical studies will be leveraged to help you through any phase of your clinical research activity. The Integra Group provides expertise in the following: 

  • Standards Determination, Initiation, Development, Review & Management
  • Medical Literature Retrieval, Review & Summary
  • Protocol Initiation, Development, Review , Registration & Publication
  • Clinical Study Planning, Management & Completion
  • Investigator/Site Identification, Qualification, Initiation, Management & Close-Out
  • Core Lab Determination, Qualification and Management
  • Adverse Event Collection, Adjudication, Resolution & Reporting
  • Deviation Collection, Correction & Prevention
  • Regulatory Report Initiation, Development, Review & Submission
  • Resource Allocation, Management & Reporting
  • Vendor Qualification
  • Investigational Product Accountability /Management
  • Study Monitoring and Oversight
  • Publication Strategy, Initiation, Development, Review & Presentation
  • Technical Writing
  • Study Completion & Closure
  • Product Approval Training & Education Initiation, Development, Review , Completion

Our staff possesses broad-based experience in clinical research, including expertise in trial design and development, project and site management, data handling and review, core laboratory coordination, and statistical analysis and reporting.

 
Clinical Research Services Site Management

Site Monitoring & Management

Integra’s site management and monitoring team will ensure that your clinical sites are open to enrollments as soon as possible and are providing accurate data for analysis and reporting. All of our research associates have experience as CRAs while working for Sponsor companies and, therefore, have a deep commitment to ensuring that the data collected in your study is done so with the utmost quality and per the protocol, the IRB requirements, the pertinent SOPs and the applicable laws and regulations.
 
Clinical Research Services Project Management

Project Management

Integra’s study managers have experience managing all aspects of first in human, feasibility, pivotal, and post-approval studies. Members of our team have managed CROs doing similar work and have a firm grasp of the importance of the relationship between you and our team at Integra.

Our project managers can focus on one aspect of your clinical study or can manage your entire clinical research portfolio. Regardless of our role in your clinical research work, our #1 goal is to manage your study efficiently and effectively, while maintaining open lines of communication with you and ensuring that all of the applicable regulations are followed and study requirements are met.
 
Clinical Research Services Project Management

Field Clinical Engineers

The Integra Group can provide a team of Field Clinical Engineers with significant research and industry experience ready to handle your clinical needs from concept to completion.

Fully Credentialed, Experienced and Insured we provide a "Task Ready Team" prepared to take your concept from start to finish with maximum effciency. 

By eliminating the time, money and energy that would be spent assembling such a team we can focus on the true task at hand - completing your project as efficiently as possibile!
 
Clinical Research Services Data Management

Data Management

The Integra Clinical Data team understands their role as part of the global study team and being accountable for the final quality of the clinical study data. Our team has many years of experience in medical device trials and uses the Good Clinical Data Management Practices as a guide. We collaborate closely with all stakeholders ensure high quality data to support the clients needs.