Example 1 – Data Monitoring

A client may request a program that involves Patient Protocol monitoring the data in greater details. Patient Protocol may propose data entry monitoring, which could include:

  • Expanded or 24 hours data entry monitoring
  • Identification of participants who have not activated the Mymee application
  • Contacting participants and trial sites who have not activated the application within expected timeframes
  • Identification of participants who have not entered data within certain parameters
  • Specific participant compliance metrics
  • Key word searches

Example 2 – Added Technical Support

A pharmaceutical company wants a highly customized program with features that require adaptation outside the standard services. The company wishes to provide exceptional technical support trial sites
and participants.

Patient Protocol may suggest extended hours of technical support services or a 24 hours call center, where trial sites and participants can call in should they have any questions or require technical assistance with the program.

In addition, design customization could include:

  • Patient surveys
  • White labeling
  • Topic customization (creating application instruments specific to your needs and requirements)
  • Patient notifications, alerts and reminders

Example 3 – Additional Patient Support

A client may request expanded support to supplement participants’ data collection capabilities, to get further insight to their potential, and to gain in depth understanding of the participants’ study experience.

Patient Protocol may suggest post-recruitment participant interviews to identify specific topic use or participant thresholds (e.g. pain, swelling, color of skin, rashes, etc.). The client could choose between group interviews vs. one-on-one in order to compare with the rest of the study group to identify potential differences. It may be very beneficial to do a washout period prior to starting the study. E.g. check for adherence and participants’ baselines such as:

  • No sugar when on an acne trial
  • Exercise requirements or restrictions during an obesity test
  • Notification of consistent headaches prior to and during clinical trial, which may indicate it is not an adverse event due to the trial drug

More data could be better because the client can get information about the participants’ lives before and during the study and easily make comparisons. Furthermore, Patient Protocol could offer the client an opportunity to gain added user knowledge by processing participant surveys. A survey could be a standard or customized survey and can be imposed on the participants:

  • As an integrated part of the program
  • Performed as a standalone
  • Driven by a call center where participants call in to

Example 4 – Expertise Consulting

A client may request consulting services and/or a second opinion around their data collection and trial design, endpoint determination and guidance.

Patient Protocol can be engaged to review existing or pipeline technologies in desired disease area, identify ways to differentiate from competitive products or gain an advantage with FDA/EMA submissions, statistic overviews and
parallels etc.