Parexel – Implementing a large-scale merger

Overview

  • Divestiture of a complex oncology business unit from GSK to Novartis created the need for a major transition programme run by Parexel.
  • affini helped to identify all the systems, processes and data sets that needed to be separated and carefully documented the current situation.
  • For each system we defined the transition strategy such as whether to clone the data or use a virtual machine.
  • This has placed Parexel in a position to move ahead with the work needed, safe in the knowledge that all the issues have been identified and the patient data will be handled with care and in confidence.

Introduction

In March 2015 GlaxoSmithKline (GSK) announced a complicated merger and divestiture agreement with Novartis. GSK acquired Novartis’s global Vaccines business, created a new Consumer Healthcare joint venture with Novartis, and divested its Oncology business.

Parexel were commissioned to provide the delivery of the oncology transition systems and manage the transition of those supporting systems from GSK to Novartis. Parexel were awarded this based on their vast experience in providing and hosting clinical trials systems and their supporting infrastructure.

Parexel headquarters are near Boston, Massachusetts, Parexel operates in 80 locations in 51 countries around the world, and has 18,620 employees. It provides the most comprehensive drug development capabilities of any organisation worldwide and has acted as a trusted partner for the complex development journey required for medical products.

Parexel choose affini as their only IT consultancy partner for the separation of the complex IT systems. affini were chosen because of their vast experience of large transformational programmes that demanded only the best.

The task in hand

The IT systems associated with oncology needed to be separated from GSK’s core IT and passed to Novartis. But this needed to happen without disrupting ongoing business including over a thousand live oncology trials, some of which had been running for over a decade. Each had sets of data that had to be carefully maintained while being separated from the GSK system and passed over to Novartis. Ensuring data integrity and confidentiality of patient information throughout was essential.

The first stage was to scope the the actual systems that were associated with the Oncology trials and then the business processes associated with those trials and systems. This involved multiple systems per task and identifying all the data that needed to be transferred and all of the associated systems that were involved in storing and processing of data.

Systems are not just an application on a server but include a collective of business process, applications, data, servers and supporting network infrastructure. Some systems need to be transferred, others replicated at Novartis and some would be superseded by new ones provided by Parexel. Over 80 systems were involved in the divestiture.

Once all current data for the systems had been collected the task was to fully documented all findings to a very granular level. This created a full library of all the systems deemed in scope, the data required to be migrated for oncology trials and the business processes to support these.

A transition plan was then developed which mapped carefully how the divestiture would occur. This involved substantial consultative work and guidance from affini in creating a new architecture that would encompass the existing systems to be cloned, the creation of new systems (to be provided by Parexel) and the separation of only the data relevant to oncology data from the vast data sets owned by GSK.

A key sensitivity was that many of the oncology trials are not yet completed and therefore unpublished. Unpublished or live studies create additional challenges for any project for several reasons. This is due to nature of the trials, the term, the random selection process and the medication administered. Any breach of data will result in a trial being deemed and invalid and ceased immediately. This could potentially mean that a decade of trials could become null and void if any data is not copied correctly across the new systems in a transformational project. This could result in losses exceeding $100m in some cases.

To clone or not to clone?

Some systems would be duplicated; others would be replaced by newer improved systems. To consider the approach for each system’s technical migration, the system’s own tailored migration plan could incorporate the use of one or more of the following technologies or techniques:

  1. Physical to Virtual (P2V) – convert a whole computer to a virtual machine then copy the virtual machine to Parexel.
  2. Virtual to Virtual (V2V) – simply copying the existing virtual machine to Parexel.
  3. Storage based duplication – copy the contents and changes at a disk or partition level from GSK to Parexel.
  4. Application level replication – data is copied using application based technique such as Golden Gate.
  5. Backup & restore – system is transferred as a backup file to be restored in Parexel.

Once systems were deemed as “clone” and or New systems new Business process and architectures were formed as part of the overall transformation program. The amount of systems deemed in scope were in the region of 80 systems. This was by no means a small task to undertake and created challenges however with the right planning and governance provided by affini the cloning and replacement system project was highly successful.

Key tasks undertaken on behalf of Parexel

  1. Outline the technical challenge associated with the transition of systems related with divestment of oncology studies from GSK to Novartis and the solution(s) identified within the in scope systems list.
  2. Make clear solution recommendations and outline the logical decision flow to arrive at the recommended migration path.
  3. Identify any additional tasks that need to be addressed by GSK, Parexel or Novartis.
  4. Provide the design documentation to enable support to be gained for both the approach and recommendations contained within the final report.
  5. Provide scope for a high level design and work packages and provide additional options for development.
  6. Identify the business processes associated with oncology and map to existing architecture. Find architecture differences and propose a new design to support both architecture and business process.
  7. Provide high level transformation strategy and the application architectures strategic direction.

affini & Parexel partnership

affini was the sole IT consultancy partner to Parexel. affini supported the programme for nearly a year, providing transformational ITO/ BPO outsourcing solutions. The programme are £15-35M transitional programmes and are seen as leading edge in the pharmaceutical market place.

affini were engaged to support the programme & project management, business analysis and architecture development requirements of multi streamed projects and successfully completed all stages within the programmes as planned. affini were responsible for providing a Programme Director who managed the key transformational programmes, several Project Managers who owned some key work streams within the programmes, Business Process Analysts, PMO Manager, PMO Analysts, Service Management and highly skilled Technical Architects.