Awarded to COFORGE U.K. LIMITED

Start date: Monday 1 February 2021
Value: £853,000
Company size: large
Health Research Authority (HRA)

HRA Research Systems Programme: Transitioning fully to the Pega Platform

7 Incomplete applications

5 SME, 2 large

10 Completed applications

4 SME, 6 large

Important dates

Published
Monday 10 August 2020
Deadline for asking questions
Monday 17 August 2020 at 11:59pm GMT
Closing date for applications
Monday 24 August 2020 at 11:59pm GMT

Overview

Summary of the work
Maintaining and supporting live Pega applications and development work to replace legacy systems, migrating data and users to allow legacy system retirement.
Latest start date
Monday 1 February 2021
Expected contract length
31/03/2023 All data/users migrated to Pega platform by 09/2022; all archiving complete by 31/03/2023
Location
London
Organisation the work is for
Health Research Authority (HRA)
Budget range

About the work

Why the work is being done
In March 2020 the HRA went live with its first Pega application. Two further Pega applications went live in May 2020 and enhancements are scheduled by December 2020.

We are looking for a Pega systems alliance registered partner with experience in cloud based Pega 8 development to both maintain and support live Pega applications and to undertake a significant development to allow retirement of 3 legacy systems onto a single Pega Platform by autumn 2022. There will be multiple user types across a wide range of stakeholders and several interfacing systems.

Further information can be accessed here: https://drive.google.com/drive/u/1/folders/1I93z_VMJykYuSvYf12uTyhFXbuAQf94U

Please note: There will be some requirement for London based working (at Stratford) supplemented by remote working. The HRA Team is based across England with some working in London (Stratford). Flexibility in relation to Covid-19 arrangements may be required for some time.
Problem to be solved
• Maintain Pega applications in production, including authentication & integration/ interfacing API management with external and internal systems
• Developing functionality to replace 3 legacy systems
• Enhance user experience and guidance
• Migration of data and users from legacy systems
• Undertake knowledge transfer to HRA team for the future
• Ensure and evidence that the system complies with all GDS Standards at:
https://www.gov.uk/service-manual/service-standard

and GDS Technology Code of Practice at:
https://www.gov.uk/government/publications/technology-code-of-practice/technology-code-of-practice

Deployments will be coordinated with other agencies (e.g. MHRA) and 3rd party suppliers. Consequently, resources may be differently profiled over time. Work will require aligned development sprints, testing and migration work with suppliers of interfacing systems.
Who the users are and what they need to do
As an applicant (researchers and sponsors) I want to:
• Register my application
• Prepare and submit applications for approval to undertake health research in the UK
• Manage my application post approval
• See status information relating to applications

As a regulatory user/volunteer committee member I want to:
• Manage reviews of all applications I am responsible for

As an NHS organisation research site, I want to:
• Manage all applications I am responsible for

As a member of the public I want to:
• View summaries of applications approved

All users need to be able to view their whole portfolio of applications
Early market engagement
The HRA commissioned an independent review of their research systems in late 2017 to assess their ability to meet future requirements in the light of EU transition and further improvements needed to support the wider UK research governance systems. This resulted in approval to procure a technical platform (Pega Systems) and associated implementation and support services to deliver a technology platform to provide the basis for the HRA to comply with future regulation associated with clinical trials of investigational medicinal products, which have introduced a need for changes to the HRA systems.

We have worked with suppliers in three phases of work prior to this engagement which have all informed this procurement.
Any work that’s already been done
• HRA have procured the Pega platform on Pega Cloud and Pega services to support initial build.
• Discovery work and high-level sizing for a wide range of future modules was undertaken in April 2019.
• The first module (CWoW IRAS portal MVP) and interfaces with 2 systems were deployed to production on 2 March 2020.
• Two further modules were deployed on 18 May 2020 (interface for Online Booking System and e-submission of amendments)
• Development is underway to enhance CWoW MVP and add registration and end of study functionality. Due to be deployed in stages by Dec 2020.
Existing team
Technical Team
• Scrum Master
• Product Owner supported by 2 Product Managers and SMEs
• 2 x BAs (one permanent; one contingent with Programme until March 21).
• QA and Test Manager + 3 x Test analysts
• 3rd party, near-shore supplier of current non-Pega systems
• 3rd party onshore supplier of identity authentication system
Programme support
• Chief Digital Transformation Officer
• Programme Director
• Programme Manager
• Resource Manager
• Commercial and Procurement Lead
• Deputy Director Finance

As we move through the programme, we will be looking to evolve our Target Operating Model for the future
Current phase
Beta

Work setup

Address where the work will take place
The HRA team is currently based in London (Elephant and Castle) with a planned move to Stratford East London in January 2021. It is expected that key members of the supplier team are co-located here but this is subject to change in the light of the COVID-19 outbreak. Any proposed near/offshore resources need to be managed by the supplier and be available during UK normal working (08.00 to 17.00 hours).
Working arrangements
The programme is being led by the HRA and any supplier will need to work within an integrated delivery/management model. There will be a requirement to co-locate however, there is flexibility to work remotely using appropriate technology, but this is subject to change in the light of the Covid-19 outbreak. A key requirement of any supplier will be to ensure effective knowledge transfer during the period of engagement and that exit of the contract is well managed.
Security clearance
N/A

Additional information

Additional terms and conditions
Additional GDPR clauses may be required depending on supplier location and outcome of UK trade negotiations related to EU Transition

Skills and experience

Buyers will use the essential and nice-to-have skills and experience to help them evaluate suppliers’ technical competence.

Essential skills and experience
  • Demonstrable evidence of successfully delivering/supporting IT Programmes on Pega platform to time/budget evidence planning / project management; quality control/ testing; deployment/release management showing timescales met within budget
  • Demonstrable evidence of successfully implementing Pega Knowledge framework, must include following: identifying/defining user requirements; UI design; deployment / release management to support user journey
  • Demonstrable evidence of successfully working within an agile / scrum methodology
  • Demonstrable evidence developing/managing multiple Pega interfaces Pega 7 & above to internal/external systems (non-Pega), include details how supplier engaged 3rd party suppliers/external stakeholders to define interface requirements
  • How will/are Pega Cloud/development skills (Pega 8/Infinity/Knowledge) be sourced incl ability supply experienced/accredited resource; System, Lead/ Enterprise & BusinessArchitects, ; Test Analyst (automated & manual testing)
  • Demonstrable evidence of how user research has informed the successful delivery of a programme of work
  • Demonstrable evidence of effective UI / UX design
  • Describe how you will work collaboratively with a partner’s in-house teams, giving examples of successful collaborations
  • Demonstrable evidence successfully managing software testing across programme of work, include performance testing, unit testing, UAT & Systems Integration Testing with 3rd party systems on Pega 8 platform
  • Describe your knowledge of and expertise in developing automated test and deployment environments and enabling a sustainable CI/CD legacy, providing evidence to demonstrate knowledge/expertise
  • Demonstrable evidence (user research used, planning migration, collaboration 3rd party legacy systems supplier, quality control, testing, successful deployment to hard deadlines) successful data/user migration from legacy non-Pega systems
  • Demonstrable evidence of scaling up and down teams to accommodate either new requirements or changes within the delivery pipeline and regulatory timescales
  • Demonstrable evidence of successfully assuming the responsibility to support and maintain live systems on a Pega 8 platform (inc Pega Cloud and AWS support)
  • Demonstrable evidence of your knowledge and understanding of accessibility standards and guidelines and explain your experience of developing systems to those standards
  • Describe and evidence your knowledge of and expertise in building GDPR compliance into systems
  • Explain with examples/evidencing familiarity with the GDS Service Standard and experience developing services/systems which enable client to pass GDS service assessments
  • Demonstrable evidence of knowledge transfer and supporting a team to be ready for Business as Usual activity
  • After identification of a successful supplier HRA must undertake a governance process with Department of Health and Social Care prior to any award of contract.
  • Confirm you can accommodate start date 1 February 2021. Confirm prices and resource/implementation plan will remain firm for period of 6 months from date of submission of proposal
Nice-to-have skills and experience
  • Describe and give examples of the challenges of working in a regulated environment
  • Describe and give examples of the challenges of working in the health and or public sector

How suppliers will be evaluated

All suppliers will be asked to provide a written proposal.

How many suppliers to evaluate
5
Proposal criteria
  • Explain/evidence proposed approach to development of technical solution to meet requirements in additional information in holistic manner.
  • Fully describe/evidence how would best leverage Pega platform/how would integrate with Pega Knowledge.
  • Explain and provide evidence as to how you will support Pega applications in the production environment alongside development work
  • Provide detailed resource plan identifying roles/levels support across team; how integrates w HRA team
  • Explain/evidence how plan will flex during implementation how resources will work alongside/ enhance HRA’s existing team
  • Describe and provide evidence of the level of Pega accreditation and experience (number of years) that the roles described in the resource plan will typically have
  • Describe/evidence proposed use of automated test/deployment tools and how these tools can continue to be utilised after contract expiry date, must detail ongoing future resource implications and license/IPR considerations
  • Describe and provide evidence of your approach to migrating from an incumbent supplier and legacy systems (based on .NET technology) to a Pega system
  • Provide details of initial milestones and how further development milestones will be agreed/monitored throughout whole of implantation and migration, recognising uncertainty around timing of any potential legislative changes
  • Describe/provide evidence of how you would conduct user research and use to inform the delivery of programme of work, recognising there are multiple stakeholders and user roles to be accommodated
  • Describe and provide evidence of how you will meet the GDS Service Standard and how you will support the HRA to pass GDS service assessments
  • Fully detail/specify assumptions made, risks identified, issues perceived/identified dependencies with full detail how you propose to mitigate against them during course of development/implementation through to closure of contract/thereafter
  • Describe and provide full and clear details in respect of the warranty arrangements for applications promoted to the live/production environment.
  • Describe and provide evidence of the value-added services that you can offer the HRA to support our Pega journey
  • Describe/provide evidence of proposed reporting mechanisms to be used throughout contract to show how contractual obligations are being met (incl. how maintenance and new development work can be differentiated)
  • Evidence how delivery to time & budget will be fully managed and maintained
  • HRA propose and outcome based payment model, please confirm that you will work with HRA to define and agree such payment model
Cultural fit criteria
  • Describe/ evidence proposed approach to working productively/collaboratively team within HRA, incl. liaison with external stakeholders/suppliers. Include how will ensure a culture of mutual respect/focus on tasks in hand, programme vision/goals
  • Describe and evidence how you will proactively share knowledge and experience with other team members
  • Describe and evidence your approach to working with clients with minimal technical expertise
Payment approach
Time and materials
Additional assessment methods
  • Case study
  • Presentation
Evaluation weighting

Technical competence

50%

Cultural fit

10%

Price

40%

Questions asked by suppliers

1. Supplier Question:
The below question under Essential skills and experience is unclear. "After identification of a successful supplier HRA must undertake a governance process with Department of Health and Social Care prior to any award of contract."
This is for information only.
The following question asks for a response from suppliers.
2. Supplier Question:
Could you please share the expected budget range ?
We are not clear on what the cost may be and would be grateful for suppliers to review the documents to ascertain the work that may be required for the programme.
3. Supplier Question:
Would it be possible to share some details on the expected outcome based payment model ?
Is it milestone based fixed price or truly business outcome based pricing ?
We would like an outcome based pricing model. We anticipate that this would be based upon successful outcomes as we move through the contract for example linked to delivery of the roadmap and various modules. This design of the payment model would be by agreement with the successful supplier.
4. What is the timeline for the procurement?
Also, the latest start date is mentioned as Feb, 2021. Do you want to start this next year only? Or can the services be started early?
Response to supplier question part A:

The timeline for the procurement is:
Shortlisting by 04/09/2020
RFP submissions by 21/09/2020
Evaluation /Moderation by 05/10/2020
5. What is the timeline for the procurement?
Also, the latest start date is mentioned as Feb, 2021. Do you want to start this next year only? Or can the services be started early?
Response to supplier question part B:

GOVERNANCE: As part of HRA internal governance we must provide a full business case to the DHSC Investment Committee that provides a full description of the overall DOS procurement that we have undertaken. This includes:
• Update of our approved Outline Business Case to a Full Business Case
• Includes full procurement report and costings etc
• Includes recommended solution and recommendation for award
HRA reserves the right to notify Suppliers who submitted proposals of the outcome of the evaluation prior to commencement of the governance process but is not obligated to do so.
6. What is the timeline for the procurement?
Also, the latest start date is mentioned as Feb, 2021. Do you want to start this next year only? Or can the services be started early?
Response to Supplier Question Part C:
It is anticipated that Suppliers who have provided a proposal will be informed of the outcome of the evaluation 22 December 2020 after DH investment committee decision on 21 December 2020. However, HRA reserves the right to alter this timetable.
With this in mind, suppliers should state within their responses that they will hold prices and the resource / implementation plan will remain firm for a period of 6 months from date of submission of proposal.
7. What is the timeline for the procurement?
Also, the latest start date is mentioned as Feb, 2021. Do you want to start this next year only? Or can the services be started early?
Response to supplier question part D:
The start date is Feb 2021 as stated. We reserve the right to bring this forward or delay as necessary.
We do not anticipate starting the services earlier than the dates specified. However, the commencement date of any contract is subject to and dependant upon approval of the FBC by DHSC investment committee.
8. Do all the nine integration/interfacing systems (internal and external) support API integration?
HRA Response Part 1:
The three main interfacing systems support API integration (MHRA medicines, CRN, and HARP). MHRA devices will probably be able to do so but this will have to be worked through.

The HRA Learning Management Systems (LMS) has API capability. The HRA Expenses systems does not – however we are not sure about this requirement yet.

Some of the sources of reference data do have API capability (such as ODS and RTS). MEDRA are developing an API with a view to it being ready for use in Autumn 2020.
9. Do all the nine integration/interfacing systems (internal and external) support API integration?
HRA Response Part 2:
Some of the sources of reference data do have API capability (such as ODS and RTS). MEDRA are developing an API with a view to it being ready for use in Autumn 2020.
https://www.meddra.org/news-and-events/news/meddra-api-be-available-testing-soon

Some of our other partner systems may have capability to use APIs (such as the ARSAC JIRA) but they may not be ready to implement and as such may instead choose to log into the HRA Pega IRAS rather than have an automated interface.
10. Please elaborate on the reporting requirements. Does the data required for reporting reside in Pega or outside of Pega?
The data required for reporting will reside within Pega. It will consist of reports in relation to
a) Reports which help us manage our business. Ie. how many applications (cases) are made, how long they take to proceed through different parts of the workflow, what the blockers in the process are, how many cases comply with certain standards/timelines etc.
b) Reports which give us data relating to case attributes. Ie. How many of what type of study, what is UK distribution of participating sites, what are in the trends in research topic, what are the trends in inclusion criteria, etc.
11. Please elaborate the requirements around the additional work for TOPS. When the new TOPS functionality replaces the existing TOPS, is there a requirement of migration?
With a previous supplier we undertook an XDC around the TOPS application and have retained that prototype. There are currently 101 site accounts in TOPS and users record individuals taking part in phase 1 clinical trials. The system will flag if individuals have taken part in conflicting trials.

Yes, there will be a need to migrate site accounts and data held. There are currently 315,307 records held in TOPS and these increase by approx. 1000 each month.
12. Can you please share a sample question set for pharmacy and radiation?
Our current supplier has built a framework for addition of question sets into which individual groupings will sit. A draft list of the pharmacy and radiation question sets are available at XXXX but please be aware
a) These are draft and not had BA work applied
b) There is some overlap with questions which are already in the system relating to study title etc.
These can be found here:
https://drive.google.com/drive/u/1/folders/1PGJE1dZQJ8TfKAcyEb7Vw5y1TyEZ5RaL
13. Please share the user stories of the outstanding development work
The user stories for the replacement work are not in place. We are working on high level user stories, but part of the requirement is for BA resource to support the further development of user stories.
14. Total number of the support cases – L2 and L3 created per week or per month
In the current Pega system in the past month we have had 387 L1 support queries. No level L2 or L3.

In our legacy systems we have had over 2000 L1 support queries. No level L2 or L3.
15. Tentative case volume per month or per week. Please provide the volume per case category/type.
Case volume for initial applications is approx. 6000 per year. (In Pega terms Non-Production study)

For each approved study there is the some update processes in terms of amendments, annual updates, safety reporting, and end of study activity. These will apply to studies approved several years ago as well as more recent one. (In Pega terms Production study). There can be up to 16,000 of these open studies in the system and each makes on average 3-4 updates per year but it is very variable.
16. What are support SLAs? – Response and resolution
Response part 1:
This is the list of scenarios and expected responses by the Help Desk.
• User access - issues reported by single or multiple users that involve guidance, user’s faults; access and process inquiries. User access is divided into three categories:
o L1: Single user reports issue that can be rectified within 4 working hours when possible with existing tools.
o L2: Single user reports issues that cannot be rectified with tools available should be referred to the Contractor and HRA for further resolution within 4 working hours of being reported.
17. What are support SLAs? – Response and resolution
Response Part 2:
o L 3: Multiple users report issues; the Help Desk should try and diagnose and rectify the issue if possible. If not possible, the issue and analysis will be referred, within 2 working hours of being reported.
• System faults – any system misbehaviour inquiries. System faults are divided into four categories:
o L 1a: Faults that affect single users but have a workaround, considered as “low” or “medium” priority issues.
o L 1b: Faults that affect single user and have no work around, considered as “low” or “medium” priority issues.
18. What are support SLAs? – Response and resolution
Response Part 3:
o L 2: Faults that affect multiple users but have a workaround, considered as “High” priority issues.
o L 3: Faults that affect multiple users and have no work around, also considered with “Critical or Blocker” priority.
Where possible these user tickets should be addressed in the same timelines as user access/business queries in terms of fault identification and communication/work around to user, but should a hotfix be required that will need to be planned in and will depend in urgency.
19. What is the volume under consideration for data migration from HARP and TOPS to Pega?
Currently there are 315,307 records in TOPs. Each record has up to 10 data points. Approximately 1000 new records are added each month.
20. What are the licensed pega applications used by HRA?
Response part 1:
The Buyer is licensed for up to following number of annual Studies:
• 7,000 Non-Production Studies raised from new each year
• 17,000 Production Studies raised from new each year
21. What are the licensed pega applications used by HRA?
Response Part 2:
Definitions
- A ‘Non-Production Study’ is a Customer Study which manages processing and completion of work including updating the Buyers other transaction systems (defined within Pegasystems as a Work Management Case). And defined within HRA as initial submission’
- A ‘Production Study’ is a Customer Study involving potentially dozens or hundreds of updates and takes more than one week from the time it is open until it is resolved (defined within Pegasystems as a Work Execution Case). And defined within the HRA as post approval update.
22. Is there a requirement for Mobile readiness (Mobile app)?
We are not licenced for this additional functionality from Pega but are aware that already people are attempting to use the functionality on their phones.
23. Can you provide any information around the infrastructure set-up – number of nodes, HA set-up, database, back-up strategy, etc.
The infrastructure is maintained by Pega cloud and has the standard 8 node configuration for production. Backups and disaster recovery is covered by the Pega cloud support.
24. Since the hosting is on Pega cloud, are there any databases other than Pega DB which is managed by pegasystems, that are critical for the application? If yes, is the support and maintenance of such database in scope?
No
25. With the initial ask it looks like the Pega application being used is on Pega 8. In the skills and experience the interface with Pega 7 and above is being asked. Which Pega 7 application is being referred here?
No Pega 7 application is in use. All is on Pega 8. We recognise that all potential suppliers may not yet have Pega 8 experience so experience with Pega 7 is minimum requirement along with confirmation that skills are updated to accommodate Pega 8 changes. Suppliers could usefully explain how they maintain skills across their workforce.
26. Can you please share a sample question set for pharmacy and radiation?
We have shared this at:
https://drive.google.com/drive/u/1/folders/1PGJE1dZQJ8TfKAcyEb7Vw5y1TyEZ5RaL
27. What are support SLAs? – Response and resolution
Response Part 1
This is the list of scenarios and expected responses by the Help Desk.
• User access - issues reported by single or multiple users that involve guidance, user’s faults; access and process inquiries. User access is divided into three categories:
o L1: Single user reports issue that can be rectified within 4 working hours when possible with existing tools.
o L2: Single user reports issues that cannot be rectified with tools available should be referred to the Contractor and HRA for further resolution within 4 working hours of being reported.
28. What are support SLAs? – Response and resolution
Response Part 2
o L 3: Multiple users report issues; the Help Desk should try and diagnose and rectify the issue if possible. If not possible, the issue and analysis will be referred, within 2 working hours of being reported.
• System faults – any system misbehaviour inquiries. System faults are divided into four categories:
o L 1a: Faults that affect single users but have a workaround, considered as “low” or “medium” priority issues.
o L 1b: Faults that affect single user and have no work around, considered as “low” or “medium” priority issues.
29. What are support SLAs? – Response and resolution
Response Part 3:
o L 2: Faults that affect multiple users but have a workaround, considered as “High” priority issues.
o L 3: Faults that affect multiple users and have no work around, also considered with “Critical or Blocker” priority.
Where possible these user tickets should be addressed in the same timelines as user access/business queries in terms of fault identification and communication/work around to user, but should a hotfix be required that will need to be planned in and will depend in urgency.
30. What are the licensed pega applications used by HRA?
Question has been previously responded to
response part 1:
The Buyer is licensed for up to the following number of annual Studies:
• 7,000 Non-Production Studies raised from new each year
• 17,000 Production Studies raised from new each year
31. What are the licensed pega applications used by HRA?
Question has already been responded to:
response part 2:
Definitions
- A ‘Non-Production Study’ is a Customer Study which manages the processing and completion of work including updating the Buyers other transaction systems (defined within Pegasystems as a Work Management Case). And defined within HRA as initial submission’
- A ‘Production Study’ is a Customer Study involving potentially dozens or hundreds of updates and takes more than one week from the time it is open until it is resolved (defined within Pegasystems as a Work Execution Case). And defined within the HRA as post approval update.
32. Please share the user stories of the outstanding development work
The user stories for the replacement work are not in place. We are working on high level user stories, but part of the requirement is for BA resource to support the further development of user stories
33. Please share the user stories of the outstanding development work.
The user stories for the replacement work are not in place. We are working on high level user stories, but part of the requirement is for BA resource to support the further development of user stories
34. Total number of the support cases – L2 and L3 created per week or per month
In the current Pega system in the past month we have had 387 L1 support queries. No level L2 or L3.

In our legacy systems we have had over 2000 L1 support queries. No level L2 or L3.
35. Tentative case volume per month or per week. Please provide the volume per case category/type.
Case volume for initial applications is approx. 6000 per year. (In Pega terms Non-Production study)

For each approved study there is the some update processes in terms of amendments, annual updates, safety reporting, and end of study activity. These will apply to studies approved several years ago as well as more recent one. (In Pega terms Production study). There can be up to 16,000 of these open studies in the system and each makes on average 3-4 updates per year but it is very variable.
36. Is there a requirement for Mobile readiness (Mobile app)
We are not licenced for this additional functionality from Pega but are aware that already people are attempting to use the functionality on their phones.
37. Any information around the infrastructure set-up – number of nodes, HA set-up, database, back-up strategy, etc?
The infrastructure is maintained by Pega cloud and has the standard 8 node configuration for production. Backups and disaster recovery is covered by the Pega cloud support.
38. Please elaborate on the reporting requirements. Does the data required for reporting reside in Pega or outside of Pega?
previously responded to please see response again below:
The data required for reporting will reside within Pega. Will consist of reports in relation to
c) Reports which help us manage our business. Ie. how many applications (cases) are made, how long they take to proceed through different parts of the workflow, what blockers in process are, how many cases comply with certain standards/timelines
Reports which give us data relating to case attributes. Ie. How many of what type of study, what is UK distribution of participating sites, what are in trends in research topic, what are trends in inclusion criteria
39. Please elaborate the requirements around the additional work for TOPS. When the new TOPS functionality replaces the existing TOPS, is there a requirement of migration?
We have previously responded to the question but, see below please:
With a previous supplier we undertook an XDC around the TOPS application and have retained that prototype. There are currently 101 site accounts in TOPS and users record individuals taking part in phase 1 clinical trials. The system will flag if individuals have taken part in conflicting trials.

Yes, there will be a need to migrate site accounts and data held. There are currently 315,307 records held in TOPS and these increase by approx. 1000 each month.
40. Do all the nine integration/interfacing systems (internal and external) support API integration?
Question has been previously answered by HRA however, please see below:
Part 1 response:
The three main interfacing systems support API integration (MHRA medicines, CRN, and HARP). MHRA devices will probably be able to do so but this will have to be worked through.

The HRA Learning Management Systems (LMS) has API capability. The HRA Expenses systems does not – however we are not sure about this requirement yet.
41. Do all the nine integration/interfacing systems (internal and external) support API integration?
Part 2 response:
Some of the sources of reference data do have API capability (such as ODS and RTS). MEDRA are developing an API with a view to it being ready for use in Autumn 2020.
https://www.meddra.org/news-and-events/news/meddra-api-be-available-testing-soon

Some of our other partner systems may have capability to use APIs (such as the ARSAC JIRA) but they may not be ready to implement and as such may instead choose to log into the HRA Pega IRAS rather than have an automated interface.
42. Since the hosting is on Pega cloud, are there any databases other than Pega DB which is managed by pegasystems, that are critical for the application?
If yes, is the support and maintenance of such database in scope?
This question has been previously answered by HRA:

No.
43. What is the volume under consideration for data migration from HARP and TOPS to Pega?
Question has been previously answered by HRA:
Currently there are 315,307 records in TOPs. Each record has up to 10 data points. Approximately 1000 new records are added each month.
44. With the initial ask it looks like the Pega application being used is on Pega 8. In the skills and experience the interface with Pega 7 and above is being asked. Which Pega 7 application is being referred here?
This question has been answered already by HRA but, please see below:
No Pega 7 application is in use. All is on Pega 8. We recognise that all potential suppliers may not yet have Pega 8 experience so experience with Pega 7 is minimum requirement along with confirmation that skills are updated to accommodate Pega 8 changes. Suppliers could usefully explain how they maintain skills across their workforce.
45. Ref Q2:
we assume this refers to the Pega Knowledge Management framework. Grateful if you can please confirm.
Can the Authority please confirm which tools are being used currently for Automated Testing, Performance and Regression Testing?
Can the Authority please list current tool set for Continuous Integration and Continuous Deployment.
It would be helpful to understand volume for the Data to be migrated from legacy applications (transactional, archival, referential data). Can the Authority share this?
Is Pega used as CRM or as Orchestration tool?
If you are referring to Q2 of the DOS advert question then yes, we are referring to the Pega Knowledge Management framework.
We are using Selenium (java) for automating the applications. Below is the software list we have installed on local machines to faciliate
1. JDK 1.8 or above
2. Maven 3.6.2 or above
3. IDE (Eclipse or Intellij)
4. All the browsers (Chrome, IE, Edge, Firefox) and their respective browser drivers
5. GIT 2.27 or above
46. Ref Q2:
we assume this refers to the Pega Knowledge Management framework. Grateful if you can please confirm.
Can the Authority please confirm which tools are being used currently for Automated Testing, Performance and Regression Testing?
Can the Authority please list current tool set for Continuous Integration and Continuous Deployment.
It would be helpful to understand volume for the Data to be migrated from legacy applications (transactional, archival, referential data). Can the Authority share this?
Is Pega used as CRM or as Orchestration tool?
part 2 response
We will be using GITHUB to store the automation code and for version control.
Apart from any tools within Pega we have no other tool set for Continuous Integration and Continuous Deployment. We are not yet at that point on our Pega journey.
It is likely that we will migrate legacy data from
- HARP – current size of HARP document database is 1.26TB. It increases at approx. 23GB per month. Currently there are 153,904 parent records and 129,774 child records.
47. Ref Q2:
we assume this refers to the Pega Knowledge Management framework. Grateful if you can please confirm.
Can the Authority please confirm which tools are being used currently for Automated Testing, Performance and Regression Testing?
Can the Authority please list current tool set for Continuous Integration and Continuous Deployment.
It would be helpful to understand volume for the Data to be migrated from legacy applications (transactional, archival, referential data). Can the Authority share this?
Is Pega used as CRM or as Orchestration tool?
part 3 response
- TOPS – current number of records in TOPS is 315,307 with approx. 1000 added per month. There are no documents stored in TOPS. Size not available but very very much smaller than HARP.

We will migrate legacy users
- IRAS – currently standing at 228,541 users (many of which will no longer be active). On average 900 new user accounts created a month
- HARP – currently standing at 3,326
- TOPS – 898 accounts and change is slow

Pega is currently used as an orchestration tool for a project and its lifecycle.
48. Ref Additional Information 1.6: Can the Authority share which if any content management tool is licensed in HRA. How is document management expected to happen?

Ref Additional Information 3.1: What is the expected support window for the maintenance of the applications?

Ref Additional Information 3.1: How many support environments does the current system have?

Ref Additional Information 3.2: What is the volume of Incidents and Change Requests raised in the current system, and the count of Service Requests raised to Pega systems?
No content management tool is licenced by the HRA.
Documents are uploaded to Pega and Pega is used as the document management tool.
If by “support window” you are referring to the timeframe in which we expect things to be dealt with these are:
o Single user reports issue that can be rectified within 4 working hours when possible with existing tools.
o Single user reports issues that cannot be rectified with tools available should be referred to the Contractor and HRA for further resolution within 4 working hours of being reported.
49. Ref Additional Information 1.6: Can the Authority share which if any content management tool is licensed in HRA. How is document management expected to happen?

Ref Additional Information 3.1: What is the expected support window for the maintenance of the applications?

Ref Additional Information 3.1: How many support environments does the current system have?

Ref Additional Information 3.2: What is the volume of Incidents and Change Requests raised in the current system, and the count of Service Requests raised to Pega systems?
part 2 response:
o Multiple users report issues; the Help Desk should try and diagnose and rectify the issue if possible. If not possible, the issue and analysis will be referred, within 2 working hours of being reported.

We have 4 Pega environments:
1. Dt1 – For Dev team
2. Dt3 – Test (for QA team)
3. St1 – Stage for SIT/UAT
4. Live

If by incidents you mean system faults reported to the Helpdesk
- Legacy systems (IRAS, HARP and TOPS) = average 15 per month
- New Pega applications = average 3 per month
50. Ref Additional Information 1.6: Can the Authority share which if any content management tool is licensed in HRA. How is document management expected to happen?

Ref Additional Information 3.1: What is the expected support window for the maintenance of the applications?

Ref Additional Information 3.1: How many support environments does the current system have?

Ref Additional Information 3.2: What is the volume of Incidents and Change Requests raised in the current system, and the count of Service Requests raised to Pega systems?
Part 3 response:
If by incident you mean user access or advice and guidance provided to users
- Legacy systems (IRAS, HARP and TOPS) = average 805 per month
- New Pega applications = average 256 per month

In addition, we have historically had approx. 40 change requests (i.e. requests to change the functionality of our legacy systems IRAS, HARP and TOPS) per annum but very variable and not all accepted.
51. Ref Additional Information 3.3: Can the Authority detail the Data Volume for Data to be migrated from legacy applications?

Ref Roadmap requirements, Migration (Tab) 5, can the Authority elaborate if this refers to Inflight cases?

Ref Q1 of Nice to have Skills and Experience, can you clarify what a 'regulated environment' means. Does this mean delivery into a regulated industry or to regulated standards, such as GDS
It is likely that we will migrate legacy data from
- HARP – current size of HARP document database is 1.26TB. It increases at approx. 23GB per month. Currently there are 153,904 parent records and 129,774 child records.
- TOPS – current number of records in TOPS is 315,307 with approx. 1000 added per month. There are no documents stored in TOPS. Size not available but very very much smaller than HARP.
52. Ref Additional Information 3.3: Can the Authority detail the Data Volume for Data to be migrated from legacy applications?

Ref Roadmap requirements, Migration (Tab) 5, can the Authority elaborate if this refers to Inflight cases?

Ref Q1 of Nice to have Skills and Experience, can you clarify what a 'regulated environment' means. Does this mean delivery into a regulated industry or to regulated standards, such as GDS
response part 2:
We will migrate legacy users
- IRAS – currently standing at 228,541 users (many of which will no longer be active). On average 900 new user accounts created a month
- HARP – currently standing at 3,326
- TOPS – 898 accounts and change is slow

Developing a migration strategy is part of the requirement and which will need to be co-produced. Choosing when to migrate the data and users will be a choice and we can work to try to minimise the number of “inflight” cases but there will always be some.
53. Ref Additional Information 3.3: Can the Authority detail the Data Volume for Data to be migrated from legacy applications?

Ref Roadmap requirements, Migration (Tab) 5, can the Authority elaborate if this refers to Inflight cases?

Ref Q1 of Nice to have Skills and Experience, can you clarify what a 'regulated environment' means. Does this mean delivery into a regulated industry or to regulated standards, such as GDS
response part 3:
We mean a regulated industry in that health research needs to comply with legislation relating to certain types of studies (Clinical Trials of Investigational Medicinal Products, Medical Device trials, studies that involve human tissue, studies that involve radiation, studies that involve adults lacking capacity, etc.).
In addition, our reviews have to comply with a wide variety of standards in order to provide assurance to the NHS that they can take part in the study.
Additionally, our IT system must comply with standards such as GDS.
54. Reference Q6: Is the user research in reference to working with the end user or the fact that we have worked with a research agency before
We mean the end user. You will note that we have lots of different types of user for the system so there will be a broad user base on which to ensure we undertake sufficient and ongoing high quality user research.
It may be that you undertake your end user research via an agency. If you have please answer the question to clearly demonstrate how this informed successful delivery.
55. 1. Could you please share the following:

a. Average number of incidents /tickets / defects/Service requests, change requests and enhancements per month.

b. SLA of the tickets by Priority

2. Does HRA uses any BI reporting tool for the BI report?
3. Is the support team expected onshore?

4. What is the support coverage expected for all three levels of support? Is it 5 days * 8 hours or 7 days * 24 hours?
1. a.
Average number of tickets per month:
- Legacy systems: (IRAS = 607) + (HARP = 193) + (TOPS (data cleansing) = 20) = 820 per month
- New Pega applications: 256 per month

Software change requests in legacy systems are approx. 40 per year

1. b
o Single user reports issue that can be rectified within 4 working hours when possible with existing tools.
56. Could you please share the following:

a. Average number of incidents /tickets / defects/Service requests, change requests and enhancements per month.

b. SLA of the tickets by Priority

2. Does HRA uses any BI reporting tool for the BI report?
3. Is the support team expected onshore?

4. What is the support coverage expected for all three levels of support? Is it 5 days * 8 hours or 7 days * 24 hours?
response part 2
o Single user reports issues that cannot be rectified with tools available should be referred to the Contractor and HRA for further resolution within 4 working hours of being reported.
o Multiple users report issues; the Help Desk should try and diagnose and rectify the issue if possible. If not possible, the issue and analysis will be referred, within 2 working hours of being reported

2. No

3. No – but they are expected to work to UK business hours and you must explain how an off or near shore team will provide support.
57. Could you please share the following:

a. Average number of incidents /tickets / defects/Service requests, change requests and enhancements per month.

b. SLA of the tickets by Priority

2. Does HRA uses any BI reporting tool for the BI report?
3. Is the support team expected onshore?

4. What is the support coverage expected for all three levels of support? Is it 5 days * 8 hours or 7 days * 24 hours?
response part 3

2. No

3. No – but they are expected to work to UK business hours and you must explain how an off or near shore team will provide support.

4. Currently we work to Monday – Friday excluding UK Bank Holidays 9am – 5pm UK time. However, we do expect system alerts relating to failures to be picked up and analysed for disaster or cyber security potential on a 24hr basis.