SOHInfo Analytics

Regulatory Submissions



Streamline Regulatory Submission & Reduce Risk of Rejection
No Data Left Behind

Reduce risk while increasing throughput for Regulatory Submissions

SOHInfo brings best-in-class literature and data capabilities to support your regulatory requirements: from 510k and PMA submissions to CER, ASUP, PMCF, CAPA, Black Label Removal or any other requirement. We begin with our Total literature review process which does not systematically exclude any potential or relevant sources.

Our meta-analytic staff is lead by Dr. Z.V. Tran, a pioneer in meta-analysis and publisher of the first meta-analytic publication in a scientific medical journal. Based on the methodology and process he has developed we produce the most complete and comprehensive analysis and reports to support your product requirements.

Support Regulatory Needs

CER

Periodic Safety Update Report (PSUR)

510K

Periodic Benefit Risk Evaluation Report (PBRER)

Post Market Clinical Follow-up (PMCF)

Corrective and Predictive Action (CAPA)

Continuous Data Updates

Continuously Scans all Selected Literature Repositories

Dynamically Identifies and Downloads

Continuously Maintains Data

Process Any Literature

Published Scientific Literature

Internal Reports

Unpublished Literature

Image description

Need scientific evidence to support your product?

Request a demo or contact us for a quote

Big Data Sets Allow For Big Data Techniques

SOHInfo's data service is designed to generate comprehensive data-sets to support research and analysis. We create data sets that cover entire domains of literature giving you the ability to efficiently generate reports and outputs to support all of your organizational requirements.

Image description
Image description
  • Interactive charts and graphs provide full insight into key elements of the data set
  • Provides complete history for visibility and traceability
  • Interactively explore each article to analyze and Identify trends and other elements
  • Complete breakdown of treatments, devices, pharmaceuticals, conditions, outcomes, biomarkers, adverse events and comorbidities
  • Generate custom analytical concepts to support continued exploration of the data
  • Group and analyze the data to best support your analytical goals
  • Download the complete data set in for in-house analysis and further exploration

About

SOHInfo is a subsidiary of MedAware Systems Inc. specializing in innovative meta-analytic and big data services for healthcare and medical science.

Contact

2525 Arapahoe Ave, E4-196 Boulder, CO 80302

+ 1 (720) 548 1280