REACHERTM

Introduction

How do you find errors that occur in the protocol-defined processes that are used to collect your primary endpoint—when are the data collected, how are they collected, who did the analysis/rating and were they trained? …..AND were the errors systematic—occurring multiple times at a single site or multiple sites?

Errors in processes associated with primary endpoints, SUSAR reporting delays, investigational product management, and informed consent management represent “Errors that Matter”. Missing these errors, especially when they are systematic, can cause serious, catastrophic consequences.

The FDA and EMA focus on the errors that matter. Missing errors that matter can also result in 483’s from the FDA and may result in censure of parts of your research subjects’ data. They can and do affect marketing approvals for your products.

To find these errors efficiently, unique software and processes are needed.

 

Technology

The MANA RBM approach provides data in a format that delivers the most effective and efficient trial oversight.

Software systems are designed to do a specific job. Electronic Data Capture was designed for capturing data, but it is not an effective tool for oversight. MANA RBM analyzes the data collected in the data collectors and document collectors to enable the study team to more efficiently and effectively find errors and correct them. We present the data in a format that enables rapid decision making.

We made the MANA Method flexible. It is technology agnostic - it works seamlessly with multiple, different technology systems, and may be implemented in any study at any time. Some of our tools are specifically designed for small companies with small budgets, while others are more automated, which work well for large, global trials.

 

The final step in completing a full remote trial management and science-driven oversight approach is our first to market software - REACHERTM (patent pending).

REACHER actively collects data from multiple data systems automatically or via manual upload.

REACHER integrates data across multiple data systems without the need for an expensive data warehouse.

REACHER automatically analyzes data across the multiple data systems.

REACHER uses the common license-free programming language, R which provides tremendous analytic flexibility.

REACHER drives workflow based on the output of the analysis. Whether it is text messages to subjects, notifications to the site team that a subject does not meet randomization criteria, or urgently notifying the Medical Monitor of a SUSAR (Suspected, Unexpected Serious Adverse Reactions) with expedited reporting- requirements--REACHER delivers the actionable information directly to the user.

In addition, REACHER is the only tool that performs three key functions:

  • REACHERTM provides a full quality management system for your trial to enable documentation of all oversight activities for your trial. This is a key requirement of ICHE6(R2). This includes Risk Assessment, Issues Management, CAPA Management, and Internal audit documentation.
  • REACHER automatically identifies major protocol deviations and determines whether they are systematic. Deviation identification can occur whether related to a specific subject or another aspect of trial conduct. Traditional deviation identification is manual and related only to a specific research subject. No trend analysis is performed. REACHER provides up to date data dashboard to access data and rapidly identify trends in issues, deviations, enrollment, screen failure. Data are presented at the study level and for each research site.

 

Supporting your trials

There are several methods for adoption.

  1. Full set up of technology infrastructure, SOPs, and training for the Sponsor to run the trial independently.
  2. Adoption of REACHER with or without J Review.
    • MANA RBM will design and validate the programming within REACHER. Monthly central review and trend analysis can be provided as an optional service.
    • MANA RBM can train the Sponsor to design its own analytics.

 

For more information, please contact Penelope Manasco, M.D., CEO Pmanasco@manarbm.com or 919-556-945