Use of Real World Data and Evidence By Industry

Published by admin - June 27, 2019

Summary

Use inCytes™ For Real-World Data Collection, Post-Market Data Reports and Other Requirements

Two objectives shared by pharmaceutical and medical device companies are (a) the development of objective data substantiating the safety and efficacy of their products, and (b) earning the attention of busy healthcare professionals.  inCytes™ provides several cost-efficient approaches to achieve both goals.

A typical sequence comprises:

Design:

The inCytes™ modular framework begins at a granular level, enabling industry participants to design desired Observational Queries, specify user-submitted values for those Queries, assign Queries to topic-specific surveys ensuring clinically-efficient response collection, and arrange those topics along a logical longitudinal clinical path. The resultant Observational Protocol captures verifiable, correlatable and relevant data pre-, peri- and post-procedurally, allowing even the smallest datum to have broad contextual value.   The inCytes™ platform can be deployed in any language, with any measurement system, without losing the canonical value of resulting data from similar Observational Queries or their Responses.

Implementation:

Industry-sponsored Observational Protocols can easily be  uploaded to inCytes™ Users accounts for immediate case fulfillment.  New users can be provided complimentary versions of the software by the Sponsor.

Report:

All resulting aggregated, de-identified data is is then available in a HIPAA/GDPR compliant manner from the cloud.  Sponsors, as well as their Investigators, can navigate through a variety of customized reporting features.

Illustrative use cases for industry include:

  • Design and execute any trial or study format. Leverage Regen Med’s existing network of clinical inCytes™ users.
  • Deliver inCytes™ to attendees at an upcoming conference or event. Coordinate an ongoing indication- or device-specific registry.
  • Sponsor inCytes™ subscriptions for top quintile HCP’s within your network. Provide white-label versions for your distributors sales kits.

The value of inCytes™ goes well beyond its clinically-powerful functionality.  In addition to their own KOL’s, Sponsors have access to leading scientists, HCP’s and Affiliates of the global Regen Med Network.