Our Services
Dedicated to building company efficiency and compliance to regulations and standards
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CLINICALServices
CLINICALServices
Why Work With Us?
Why Work With Us?
Across our amazing team we have over 10+ years of experience in conducting complex global clinical trials and in medical writing. We have conducted numerous clinical evaluations and written multiple regulatory documents for EU MDR submissions that have received multiple EU MDR approvals across multiple therapeutic areas. We have skilled professionals in all aspects of clinical trial operations for medical devices. In addition, we are dedicated to training more aspiring writers and diversifying our field. We do not just want to work with you, we want to build a partnership that will grow your company to achieve success.
Our Clinical Trial Operation
Our Clinical Trial Operation
SERVICES
SERVICES
We have experience with the entire clinical trial process and are here to assist you with your clinical trial needs from strategy to market.
I. Study Start-Up
Site selection
Informed consent
Contract and budget negotiations
Clinicaltrial.gov registration
IRB Submission
II. Monitoring
Remote and on-site monitoring (SQV, SIV, IMV, COV)
Monitoring plans and reports
III. Trial Master File
Site files and documentation organization
Our Medical Writing
Our Medical Writing
SERVICES
SERVICES
We specialize in the regulatory writing niche of medical writing. Whether it is preparing part or the entire document, we are here to support your needs.
I. EU MDR and more...for Class I (s,r,m), Class II (a,b), Class III
EU MDR submission support
Clinical evaluation plans and reports
Systematic literature review (inclusive of appraisal criteria, inclusion/exclusion criteria, data extraction for easy analyzing)
Post-market clinical follow-up (PMCF) plans and reports
Summary of Safety and Clinical Performance (SSCPs) for both non-implantable and implantable
Inputs to Periodic safety update reports (PSURs)
Periodic updates under EU MDD as products transition to EU MDR
II. EU IVDR and more...for Class A, B, C, D
EU IVDR submission support
Performance evaluation plans and reports
Scientific validity, analytical performance and/or clinical performance reports that serve as an input to the PER
Systematic literature review (inclusive of appraisal criteria, inclusion/exclusion criteria, data extraction for easy analyzing)
Post-market performance follow-up (PMPF) plans and reports
Periodic updates under EU IVDD as products transition to EU IVDR
III. Clinical Trial Documents
Protocol development
Clinical study plans and reports
Informed consent
Investigator brochure
Manuscript and publication support
IV. Internal Quality Processes
Work instruction (WI) and standard operating procedure (SOP) development
Template development for all above documents
CONNECT. PARTNER. GROW
CONNECT. PARTNER. GROW
Still have questions? Contact us
Still have questions? Contact us
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