Clinical Research Services
The Integra Group offers clinical research services that may start from inception of your investigational product through post-market approval clinical trial completion. With over 10 years of combined experience in medical device and pharmaceutical clinical trials, our experience and knowledge in domestic and OUS trials can help you at any phase of your research activity. Integra 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.
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Site Monitoring & Management
Integra's CRAs will keep your clinical sites in-line and on track.
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Project Management
Don't need an entire clinical department? Integra can provide support for a wide range of clinical projects.
