Serving Life Sciences

• Multiple sources for common data items and lack of authoritative data sources.
• Known and significant issues with data quality and integrity.
• No effective data quality management function in place.
• Existing reporting environment was very fragmented and inconsistent.

Hawkins Point evaluated information systems used by the different functional teams (Global Clinical Operations, Regulatory & Data Management) that were involved in the management of Clinical Data flows for the company to provide the following improvements:

• Standardized reporting and dashboarding mechanism across multiple sources with ad-hoc capability.
• Establish single comprehensive source of truth for operational data, to include current and historical data.
• Standardize data definition, ontology and vocabulary.
• Designing Aggregation & semantic layers with virtual, federated data Marts for consistent reporting.

• Implement Data Governance Structure, Policies, Workflows, and Organizational/Cultural Change.
• Created Standardized DataHubs, Marts, and Data Warehouse to support one version of the truth.
• Delivered streamlined and consistent reporting for Management, Transparency and Regulatory stakeholders.

Client was executing against their commercialization roadmap. The initial implementation plan included deployment of the following business functions: ERP Oracle, Materials Management (LIMS), Safety DB (Pharmacovigilence-Argus), HRIS (Workday/Fusion/ADP), EDMS for Clin/Reg/QA (Nextdocs/Veeva Vault), LMS (Sumtotal/Successfactors).

Hawkins Point leveraged our Software Deployment, Program Governance, and Project Management frameworks, assets, and accelerators to define and execute processes to ensure successful implementations. We implemented all processes and performed vendor management responsibilities for all software vendors and system integrators. We developed and managed the deployment and integration plans for each platform.

• Managed the successful implementation of six different software products all of which were delivered on-time and within budget.
• Provided all vendor management services on behalf of the client.
• Developed and managed mitigation strategies for several critical risks.
• Directed all hypercare activities to ensure effective post-implementation support.
• Established consistent progress communications, and provided program level roll-up reporting to executive committed for all implementations.

To comply with Federal regulations on Clinical Trial Disclosure, the Clinical Trial Transparency Group needed to develop strategies and plans for the following areas:

• New Protocol Registrations on Global Clinical Trials registries such as ClinicalTrials.gov.
• Maintenance of existing records on ClinicalTrials.gov.
• Reporting Clinical Trial Data that met FDAAA regulations.

Hawkins Point Partners evaluated information systems used by the different functional teams (Global Clinical Operations, Medical Writing, Regulatory & Data Management) that are involved in the management of Global Clinical Trials for the company to provide the following assessments:

• Identification of new protocols to be registered.
• Active trials for new updates.
• Assessing completed trials for data reporting.

• Recently approved Clinical Trial protocols were easily identified and fast tracked for Clinical Trial registration.
• The assessment supported clinical trial registration and planning. This information will be used as part of a tool being created for group.
• Completed clinical trials underwent further analysis to achieve a finalized list and an action plan was in the process of development to address any clinical trials that needed to have data disclosed.

• The organization was in the early stages of implementing multiple Salesforce solutions that would introduce significant change events for all individuals whose jobs contain touch points to customers that included Sales, Marketing, and Customer Support.
• The company was expanding the internal use of its own commercially available products, and there were a large number of major technology projects in the pipeline.
• The organization needed be prepared to absorb and adopt all of this change.

Hawkins Point leveraged our Organizational Change Management playbook and framework to create a pragmatic OCM business capability. We also leveraged our knowledge base, and industry best practices considering the distinct culture, capability and commitment of the client.

• Delivered and executed a repeatable process that was institutionalized as a business capability, designed to evolve over time.
• The Change Program was actively supported by executive management. This program was delivered via a collaborative execution approach, implemented in concert with the client and business customer, as an integrated work stream of the overall Salesforce implementation program.

• A fully prepared organization, impacted team members, and customers for pending changes.
• Assessed and facilitated organizational readiness and capacity for change.
• Understood impacts of planned changes as a precursor to engaging and preparing the workforce for those changes.
• Ensured changes made within the organization were implemented in a manner designed to minimize dips in productivity.
• A repeatable business capability, with all methods, standards, tools, and templates, with embedded continuous improvement

• Client needed to replace their current Serialization solution as it did not meet the needs of the business.
• The current solution was also deemed to fail requirements by world health regulators.

• Hawkins Point leveraged our Project Management framework and assets to plan and manage the implementation.
• Developed the project plan that defined project scope, objectives, success criteria, and budget.
• Defined management strategies for communication, requirements, resources, schedule and quality.

• Succesfully delivered on a $2.8M project budget
• Managed combination of client resources and outsourced manufacturing resources.
• Reported project health to portfolio managers on a weekly basis.
• Successful implementation of a validated (GxP) solution at internal manufacturing site (EU) and multiple outsourced manufacturing sites (US).
• Solution met all regulatory requirements for US and EU before serialization.
• Project protected revenue of $2.4B in sales.

Due to years of disparate IT initiatives, the R&D business unit found that the application portfolio had the following application challenges:

• High cost to maintain applications that deliver little value to the business
• Technology sprawl with multiple apps providing similar functionality
• High risks associated with unpredictable software products or vendors
• Unused purchased software licenses.

Hawkins Point Partners leveraged our Application Rationalization framework to develop a Strategic Roadmap to meet objectives. We performed in-depth discovery, from both a technology and business perspective, using proven tools to quantify the value, cost, and risk associated with each application. We worked closely with IT leadership to define and weight the criteria used to measure the value, cost, and risk of each application in scope. We summarized the disposition of each application and delivered an 18 month Roadmap of initiatives to address the findings.

• Immediate retirement of approximately 10% of the portfolio, leveraging our Application Retirement Framework
• Identified multiple projects to replace applications by migrating functionality to an existing platform
• Planned for the retirement of high risk legacy technology applications
• Significant reduction in the amount of required software licenses for portfolio users.