Case Study: Implementing an AWS Solution for Pharma

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Our client, a global biotechnology organization, needed to implement a qualified & validated IT solution to store, transform, query, analyze, and share clinical trials and Genomics data in the cloud environment. As a long-time partner of this client, MIGSO-PCUBED was engaged to support the implementation of this complex cloud-based IT solution using Project Management tools and methodologies.

Having specialized in Program and Project management for over 30 years, our consultants helped the client deliver the solution on time, within budget, and with fully realized key benefits within the organization.

Table of Contents

Business Challenge

Pharmaceutical organizations must have the ability to ingest, store, and protect large volumes of data including clinical, genomic, and scientific data. First, the team needed to identify the appropriate tool to implement that could support this influx of data.

AWS is well-suited to this data deluge with a wide variety of ingestion, storage, and security services (e.g., AWS Direct Connect, Amazon Kinesis Streams, Amazon S3, Amazon Macie) to handle clinical data. An AWS solution also helps address the problems that the healthcare industry faces around data security, which is increasingly attractive to cyber attackers, making security a top priority.

The implementation of a qualified & validated cloud-based IT solution to manage the customer’s data, which would affect over 3,000 employees worldwide, came with major considerations for the MP team. Being tool-agnostic, our team was able to analyze and determine the best tool for our client’s situation. The selected tool also needed to comply with FDA regulations and support both UK and US regions. Considering these parameters, the team selected the AWS S3 tool as a viable solution that can easily integrate with external SaaS systems and other internal systems.

To comply with the regulatory standards, the client needed a viable solution in place by a certain date. Under a tight timeline and budget, the team needed to implement a complex solution with various constraints and dependencies. The MP team helped meet the identified goals successfully by following a planned project management approach.

Implementation of an IT Solution

MIGSO-PCUBED was brought on board in partnership with the organization’s PMO to implement this challenging solution which involved qualification of the cloud-based IT solution.

Our consultants quickly began by working with various IT teams within the organization including IT Infrastructure, IT security, IT architecture, Data Sciences, etc. to create a roadmap for the solution to ensure the project’s scope and objectives were clearly defined, the right resources identified, timelines agreed, etc. The team worked through four phases to execute the project: Initiation, Analysis, Deployment, and Closure.

We focused heavily on schedule management, risk management, and cost management components to deliver the program’s objectives as quickly as possible and within the approved budget, while ensuring that the project risks were managed and mitigated in a timely fashion.

IT Solution Implementation Process

Initiation

Our consultants held a scheduling kick-off meeting, which allowed them to create a detailed project plan, set up the timelines in MS Project, identify key project resources, document project objectives, deliverables, and scope, as well as draft the project budget baseline. Then, the team constructed a project charter according to the client’s standard processes. They also worked with the legal team to begin the vendor procurement process. Finally, they developed a communication and risk management plan to share with the project team.

Analysis

The MP consultants quickly engaged external vendors to support internal gaps in the design and implementation of the solution. To support these additions and use of external vendors, our team put together a detailed proposal that included not only impacts on project timeline, scope, and budget, but also presented the change request to the client’s senior leadership for approval. A detailed roles and responsibilities (RACI Matrix) document was created to avoid any ambiguity amongst various IT teams.

A validated project has a much more stringent process of documentation and verification to follow GxP and GDPR guidelines. This steers the direction and timeline of every project. In response, the consultants needed to update their project plan to include tasks and deliverables for these activities. This phase also identified the project IT requirements and system specifications. Therefore, it must be led by consultants with the technical knowledge needed to facilitate it.

Deployment

The solution required robust testing, as one of the requirements was to deploy a qualified and validated IT solution. Detailed test plans were developed, and the system was tested appropriately. Our consultants brought their expertise to conduct user acceptance testing. Testing phases are often conducted in an agile fashion to ensure rapid testing and updates to the solution and deliverable(s). This was done smoothly by our consultants as they are well-trained in utilizing both Agile and waterfall principles. Once the consultants ensured approval from the system owner and responsible parties, the project was ready for deployment.  A detailed Go-live checklist was created to make sure all the necessary things are in place before Go-live.

Our consultants’ role was very crucial in this phase to keep the project deployment on track; deployment dates often depend on the planned downtime of other systems.

Closure

During the Closure phase, after making sure the team completed the project closure checklist, our team held a retrospective session to collect and document lessons learned. All the financials were closed in the PPM tool and a final release memorandum was sent to the entire PMO team to finalize a successful project closure.

Value delivered by MP

Working alongside the client’s team, MP successfully implemented a qualified and validated AWS S3 solution for the first time at the client’s organization. This implementation was the first step in paving the way to develop more qualified cloud-based solutions.

The client found that MP’s support on this project allowed them to effectively manage the project’s scope, schedule, resources, and budget with continuous monitoring and team engagement. Clear communication and coordination helped the team set clear expectations and avoid conflict and confusion, which helped achieve a quality product. By managing the stakeholders and overall team, the client avoided struggles with user adoption and increased accountability and focus within the organization.

As an experienced project management partner, MP could combine industry best practices to achieve results throughout this project, including:

  1. Change management principles, resulting in increased productivity, reduced stress, and improved decision-making.
  2. Risk management principles, allowing the team to proactively identify risks, implement mitigation plans, and provide swift resolutions to avoid impact on the project timeline and quality.

All different business units within the client organization reported that they were happy with the quality of the outcome of this engagement. The client continues to see value in the partnership that MP provides on an ongoing basis. With so many complex projects and initiatives, our partnership with them has provided experienced and more adaptable project and portfolio management capabilities.

This article was written by Prashanth Kotla.

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