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. Assess out-of-the-box reports and data exports and visualisations using realistic mock data

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

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

5. Considered system configuration items are being manually copied to Pre-PROD

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

4. Ensure a ‘clean’ library of evaluated forms are kept and managed ready for use in formal testing and to be the basis of an approved forms library

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

Integrations such as safety lab integrations, may be available for the CFP. Some custom system integrations or newly commissioned device integrations may also be available at this time. If not they need to be evaluated in work streams outside of more formal pilots.

...

1. Device integrations

2. Use of reporting APIs

3. Website integration

4. Use of Read Replica for custom queries, KPIs and reporting

5. SMS and email integrations

6. SSO

7. VCT

Operational

1. SMEs will be firming up key aspects of SOPs and work instructions

2. Thorough examination of out-of-the-box reports and data exports and visualisations using realistic mock data

3. Ensure that Roles are maturing and that participants conducting pilots use assigned Roles rather than running as ‘administrator'

4. Staff will be revising test cases based on their earlier pilots in the Sandbox. Some test cases will be good enough to ‘dry run’

5. Decisions on system configuration items may be being revised based on experience with earlier pilots. Update these and add new system configuration items manually to Pre-PROD

Study Build, Test and Release

1. Build or adapt a more extensive range of forms needed for executing a pilot with a complex study protocol

2. Update and finalise the ‘clean’ library of evaluated forms ready for formal testing and to be the basis of an approved forms library

Starting Validation

1. Draft SOPs are available

2. Draft training materials are available for end users

3. Test cases have been ‘dry-run’ in the Sandbox

4. In Pre-PROD

   1. Ensure system configuration items are in the intended state for production including applicable device and system integrations

   2. All user Roles are defined

   3. Optionally, upload the final ‘clean’ forms library as an ODM XML import

5. Pre-PROD is copied to make VAL

6. Validation

   1. Formal testing is conducted in VAL

   2. Formal testing is completed and approved with any consequential adjustments to configuration being made in Pre-PROD

Moving to Production

1. Final SOPs are published (some organisations allow training on pre-approved SOPs)

2. End-users complete final role-based training

3. Where applicable

   1. The pre-approved volunteer database migration from legacy system is executed at a chosen cutover date

   2. Pre-Prod is now designated PROD and is a fully ‘hardened’ environment designed to securely process participant PII and PHI

   3. A PROD ‘Test’ environment is created and made available to the customer

   4. External integrations are made live (e.g. configuration adjusted to production settings)

4. Qualified and trained end users may be provisioned to the PROD environments

Integration of parallel work streams

The following work streams may run in parallel with the conduct of pilots and will intersect depending on their maturity at any given time.

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