Scene setting

This article was written to address the following questions…

• What are the key activities/milestones/decisions that need to be made prior to Conference Room pilot

  • Workflows?

  • Configuration?

  • Hardware?

  • Integration?

  • Operational?

• What are the key activities/milestone/decisions that need to be made prior to Clinic Floor Pilot?

• What are the key activities that need to be completed prior to moving to Validation environment?

• What are the key activities that need to occur around environment promotion from VAL to PROD?

• What are the key dependencies between the build stream and integration streams, and how to best manage forward progress on both of these simultaneously

Introduction

Pilots should be conducted early and often as this can be one of the most effective ways of shaking out issues and developing your eSource processes.

In some cases customers request assistance with the conduct of selected pilots, either virtually, or in person. Don’t wait for IQVIA SMEs to come on site, try running your own pilots as soon as you feel you are ready. Treat a pilot with IQVIA SMEs on-site as an opportunity for refinement and process improvement.

Project Timeline

An example timeline showing Roles and Responsibilities.

Bootcamp

In general, preparation for the Conference Room Pilot (CRP) should follow the general themes covered in the on-site bootcamp training.

Conference Room Pilot

Items to consider prior to CRP.

Set customer configurable configuration items

1. Volunteers | Configure

2. Devices | Configure

   1. Including

      1. download and installation of ClinSpark Agent

      2. download and install of free Zebra label designer software

      3. use of mock devices

3. Barcode Printing | Manage

   1. Either use basic templates out of the box or edit them, or design custom labels

4. Administration | Roles

   1. Accept the out-of-the-box Roles or start to customise them

5. Administration | Sites

   1. Add site details and configure accordingly

6. Administration | Medical Dictionaries

7. Administration | General Settings

   1. Authentication / Authorization

   2. Barcodes

   3. Data Collection

   4. Lab

   5. Phone Number Validation

   6. Samples

   7. Specimen Containers

   8. Volunteer Settings

8. Learn how to export the configuration report PDF

Review protected configuration items with IQVIA superadmins

Defer any of these as necessary to the CFP.

1. Administration | Sites

   1. Configure mock-lab

2. Administration | General Settings

   1. Advanced System Setup

   2. Communications

   3. ECG

   4. Lab

Integrations

Integrations such as safety lab integrations, are unlikely to be available for the CFP. This particularly applies to custom system integrations or newly commissioned device integrations. In some cases workflows relying on these integrations can be emulated, ‘faked’ or simply ignored until they are available.

Operational

1. All SMEs will have been trained in their key and core areas of responsibility and exercised their anticipated tasks independently in the Sandbox

2. SMEs may already have started sketching out the key aspects of SOPs and work instructions

3. Staff may already be working on drafting test cases based on their efforts in the Sandbox

Study Build, Test and Release

1. Build or adapt at least the core forms needed for the study that will be used in the first pilot

2. Create the activity plans and add these to the applicable cohorts as demonstrated in training and explained in the documentation

3. Exercise exporting study designs from PROD to TEST

Clinic Floor Pilot

Items to consider prior to CFP.

1. Administration | General Settings

   1. Communications

      1. Advanced System Setup

         1. Single Sign On - if applicable

         2. Verified Clinical Trials - if applicable

      2. Twilio, SendGrid

   2. ECG

      1. Dependent on use cases

   3. Lab

      1. Where applicable. The safety lab integration may be configured enough to an advanced state suitable for inclusion in later CFPs

Integrations