Serving Life Sciences

Client recognized that systems supporting small molecule drug discovery were reaching a critical state due to uncoordinated investment, stagnation, and technology sprawl. There was limited engagement between IT and the functional areas. With new senior management across IT and the scientific organization, client recognized a need for new working ways and systems landscape to support the evolving needs of the business stakeholders.

Hawkins Point worked across Research IT and the scientific departments to establish a new governance approach, creating an Operations Team, facilitating a Steering Committee, and comprehensively engaging IT and the business. We provided deep domain expertise in research and development and implemented a central data repository for scientific assay results.  Additionally, we developed a foundational set of data flow and process models and facilitated a business-led data governance initiative.

Due to years of disparate IT initiatives, the R&D business unit faced challenges with its application portfolio. There was a high cost to maintain applications that delivered little value to the business. Technology sprawl with multiple applications providing similar functionality existed. There was high risks associated with unpredictable software products or vendors, and purchased software licenses going unused.

Hawkins Point Partners leveraged our Application Rationalization framework and accelerators to develop a strategic roadmap to quantify the value, cost, and risk associated with each application. We performed in-depth discovery, from both a technology and business perspective. Also, Hawkins Point defined and weighted the criteria used to measure the value, cost, and risk of each application in scope. We summarized the disposition of applications and delivered an 18-month roadmap of initiatives that included modernization, retirement, and increased adoption of existing platforms.

To comply with Federal regulations on Clinical Trial Disclosure, the Clinical Trial Transparency Group needed to develop strategies and plans for new Protocol Registrations on Global Clinical Trials registries (such as ClinicalTrials.gov); maintenance of existing records on ClinicalTrials.gov; and Reporting Clinical Trial Data to meet Food and Drug Administration Amendments Act (FDAAA) regulations.  

Hawkins Point evaluated information systems used by the different functional teams (Global Clinical Operations, Medical Writing, Regulatory & Data Management) to provide assessments for identification of new protocols to be registered. Also, Hawkins Point was able to provide reviews of completed trials for data reporting and active trials for new updates. 

Client recognized small molecule drug discovery evolved without a unified systems strategy and with limited focus. A poorly understood landscape that lacked data flows and process maps made it difficult to articulate new technology management strategies.  A significant investment was required to improve scientific data analysis and management. 

Hawkins Point collaborated with Research IT staff and scientific departments to develop a series of data flow models. These models described the processes of compound creation through assay development and execution, documented with process descriptions, data flow types, and software. We also established a process for selection of development candidates. Additionally, Hawkins Point developed a reporting application providing tabular views of data and process information. Models were used to support decision-making, systems selection, and implementation choices.

Client recognized the need to upgrade the existing ChemReg solution, bringing the software up-to-date, extending its active life, and adding additional features, functions, and benefits. The client also took the opportunity to upgrade the hardware platforms and database versions.

Hawkins Point provided deep domain expertise and project management discipline to the R&D IT organization, to lead the upgrade program of this critical software package for Research IT. Working with the various Research IT team leads and the scientific departments, we created a Project Team and Steering Committee to deliver the project from the financial approval stage in the client’s SDLC process flow. This multi-month project involved a number of stakeholders within the client and a number of vendors, all needing to work together within this complex matrix environment to deliver the final solution and integrations.

Client was far behind in upgrading to the currently available version of the solution and was in jeopardy of losing vendor support. The application analyzed all types of screening and assay data such as high throughput, high content, and SPR (Surface Plasmon Resonance) for both single concentration and dose response studies. The client needed deep domain expertise and project management competency to ensure a successful upgrade.

Hawkins Point led the upgrade program for Research IT. Working with the various Research IT team leads and the scientific departments, we managed every aspect of the delivery cycle. We worked closely with key business stakeholders to gain a full understanding of the business requirements that were not being fully satisfied by the current solution. We then worked directly with the software vendor to design configurations and customizations that were required to ensure the solution met the needs of the business. We employed disciplined quality assurance methods and directed a system upgrade that met each defined business objective.

Client was far behind in upgrading to the currently available version of the solution and was in jeopardy of losing vendor support. Therefore they recognized that to ensure continued support from the software vendor and to remain compliant with regulatory requirements, they would need to upgrade and validate the existing clinical shipment temperature monitoring solution.

Hawkins Point delivered Project Management services to support the upgrade of web-based application database/visual tool and upgrade of desktop application, all of which is used as a clinical drug supply temperature monitoring solution. We developed the overall implementation and integration plans, and managed project execution to deliver the upgraded version. We worked closely with the software vendor to ensure quality assurance activities were performed in accordance with client standards.

The client was in the late stages of clinical testing and was preparing for approval and commercialization. This required significant remediation of current systems and validation/compliance support for the systems to meet organizational processes requirements and inspection readiness. Also the company was expanding and there was a large number of major technology projects in the pipeline. The organization needed be prepared to absorb and adopt all of this change and improve their compliance profile.

Hawkins Point Partners leveraged our IT Quality Framework and accelerators as well as Organizational Change Management playbook to create a pragmatic remediation roadmap and ongoing organizational culture change. We leveraged our knowledge base, validation governance toolkit and industry best practices. We delivered a quality system, executed a remediation strategy, and implemented a repeatable quality process. We supported the correction of numerous system compliance gaps and managed implementation and validation of other systems.

The client needed to improve the current CSV methodology, supporting CSV framework and quality model. They were seeking guidance to develop a CSV framework to support the implementation of technology solutions which will need to be validated. They needed an assessment of current validation needs, understand tool options, quality systems (procedures) and support the current compliance profile. They also wanted a “right-sized” framework for validation and quality/compliance that could scale to meet planned growth.

Hawkins Point leveraged our IT Quality Framework and accelerators to define and implement a right sized validation approach. We reviewed the current CSV process governance, procedures and existing methodology that were in place. We documented the current state of process and determined the desired outcomes. We delivered recommendations for Policies, SOPs, CSV validation templates. We provided guidance, job aids, and awareness training as function of client adoption.

The client needed to assess and document the business process and data management and governance for Research Documentation in support of a recent Investigational New Drug (IND) application filing.  The company identified that the process management, repository, and effectiveness of the current workflows presented numerous areas of inefficiency.

Hawkins Point mapped the current business process workflows used to manage the development, collection and curation of research documentation and outputs which supported the client’s pre-clinical research and regulatory compliance to applicable predicate rules. We documented the operational business requirements, mapping of data sources and consumers, and data integrations, including to third party service providers.  We also documented data integrations with internal systems and partners supporting research studies, clinical trials, and overall data management for all regulatory compliance activities.

The client intended to perform a risk assessment of their current practices, documentation, infrastructure, and software to determine if any business and/or regulatory compliance risks existed, and to develop a mitigation plan. The assessment was to be conducted with respect to US and EU regulatory requirements (for example, GDPR, Annex 11, HIPAA, FDA predicate rules, and 21 CFR Part 11).

Hawkins Point Partners leveraged our IT Quality Framework and accelerators to perform the desired risk assessment and mitigation strategy. We performed discovery sessions with client personnel to understand current and planned processes and practices. We reviewed procedures, vendor agreements, and evidence documents for business and/or compliance risks. We also analyzed the current infrastructure and security, networking, server, and storage devices for business and/or compliance risks. In addition, software platforms were assessed for business and/or compliance risks.

As client grew closer to FDA approval they recognized the need for a robust Quality systems methodology and the governance documentation to meet organizational gaps and compliance with regulations. Client desired to take an iterative approach to identifying high priority SOPs, including change management, periodic review, and CSV procedures.

Hawkins Point assessed the client’s plan and proposed additional necessary governance, which included a Quality Manual and CSV policy, validation deliverables, program governance and project management framework, assets and accelerators to build out the turn key quality systems, and execution work instructions to ensure successful validations and implementations. We developed all documentation and processes, and performed assessments based on the current industry standards. Hawkins Point focused on vendor management responsibilities for all software vendors and system integrators as contract gaps and opportunities to tighten vendor SLAs existed.

Client expected its first product to receive FDA approval and was preparing to deploy their Sales team in preparation for the product launch. Client had both Salesforce and Veeva in place as potential CRM solutions. Client desired a rapid assessment of which platform was appropriate, and desired a implementation and integration plan.

Hawkins Point Partners recommended Veeva as the optimal choice due to its “Plug and Play” orientation, reducing the need for internal technical resources and customization. Hawkins Point Partners used a multiphase approach with 7 iterations over a 10-week period. We developed all test cases, scripts, and sales rep training, while also implementing an operational change model, support framework, and a detailed communications plan. During this time, we supported the client’s efforts in content creation/approval, data loading/validation, and third-party integrations.

Client’s IT Operations and Infrastructure was performing significant IT infrastructure build-out projects in support of new manufacturing facilities and the implementation of new application solutions. The client did not have mature governance processes in place and recognized that they were in need of strong Program and Project Management disciplines to ensure that the infrastructure was ready to support the new facilities and software implementations.

Hawkins Point managed internal client IT resources, vendor partner resources, project timelines, costs, reporting, and deliverables for all projects, as well as multiple projects with a global footprint. We worked with both IT and business partners to document business and functional requirements and optimize for scale. Hawkins Point brought to the client our Program Governance and Project Management frameworks and accelerators to define and implement a right-sized approach to ensuring successful service delivery.

Client was preparing for a new product launch that would introduce new channel data into the commercial environment (that is, Veeva CRM, Commercial data warehouse, and patient services hub). Business unit leadership determined that MDM capabilities were lacking in the existing environment, to support a successful product launch. Veeva Network and OpenData were selected as the go-forward MDM platform.

Hawkins Point delivered Commercial Data subject matter expertise and Program Management to define the implementation plan for the rollout of Veeva Network. The first phase involved matching HCPs from each Therapeutic Area (Neurology, Oncology, Fertility, Endocrinology) against Veeva OpenData, and enriching the HCP profiles in Veeva CRM. The subsequent phases focused on migrating the affiliated HCOs into Veeva CRM, and integrating Veeva Network for ongoing integration and mastering. We also counseled the client’s Commercial Ops and IT while curating and preparing the data from Veeva CRM to be matched by Veeva professional services against Veeva OpenData.

The client was seeking a Managed Services partner to provide reporting and analytics services to commercial stakeholders. The existing Managed Service Provider was proving to be unresponsive and was providing inadequate support for the needs of the business. The client needed to engage with a partner would not only provide a qualified and scalable team, but also identify and execute on process improvements to enhance the business partner experience over time.

Hawkins Point quickly created and deployed a skilled team to transition support of the commercial reporting environment from the current provider to our team. We worked closely with the client’s team to ensure this transition did not disrupt service, gradually taking over and leveraging current provider resources until the transition was complete. The Hawkins Point team provides reporting, extract and quality assurance services. As part of the service Hawkins Point provides senior executive oversight to ensure we are providing optimal service, manages resource performance, flexes the team with demand, and continually optimizes processes and methods.

The client’s Serialization solution was no longer meeting the needs of the business and the total cost of ownership was prohibitive. The current solution was also deemed to fail regulatory requirements. Therefore the client needed to retire the current system and implement a new solution.

Hawkins Point provided deep domain expertise in Serialization and Supply Chain, and project management discipline to support the business and IT organizations. We led the upgrade program, working closely with a diverse group of stakeholders. We defined management strategies for communication, requirements, resources, schedule and quality. During solution design, Hawkins Point’s deep domain expertise in Serialization was a key component of project success. We were able to translate business requirements effectively to the integration team, resulting in a solution that met business needs.

The client found that numerous manufacturing sites contained far too much inventory. There was a lack of consistent business processes and systems to optimize inventory. The Oracle ASCP module was in production but had not been implemented correctly and so was not adopted. The current state had inventory tracking performed on spreadsheets. The client needed to optimize, but also needed to maintain high service level, while freeing up working capital.

Hawkins Point provided deep domain expertise in Supply Chain and Program Management, and specific experience with Oracle ASCP. The team worked closely with the planners community, product supply teams, and product manufacturing teams. We worked with the business community to determined root cause of low adoption. Hawkins Point designed a solution that included a mix of newly defined optimized business processes and a newly designed configuration for the Supply Chain platform. We ensured real time availability of inventory levels, introduced new features, and delivered the ability to measure performance for each site.

As a result of on-going and frequent merger and acquisition activities, the client had multiple finance platforms across a number of entities. There was a wide range of different financial reporting tools and systems currently in place that served many of the same functions. Processes were manually intensive and there was limited automation.

Hawkins Point engaged with the client to execute an assessment of the risk associated with the current Finance system footprint. We performed a current state assessment of data flows and supporting business processes, including manual and automated activities required to consolidate financial information for reporting purposes. Additionally, the core accounting systems of select affiliates were evaluated against multiple criteria. The outcome of the assessment yielded a risk analysis, current state assessment, and a prioritized recommendations. 

Client was executing against their commercialization roadmap, with plans to implement ERP, LIMS, Safety DB, HRIS, CRM, and EDMS for Clin/Reg/QA. Client recognized the challenge of managing multiple software vendors and system integrators and needed a common approach to governing the program.

Hawkins Point leveraged our Software Deployment, Program Governance, and Project Management frameworks, including assets and accelerators to establish governance and execute a successful implementation for each platform. We instituted standardized governance procedures to ensure that planning, implementation approach, quality assurance, and progress reporting were executed and delivered in a uniform manner. This enabled reliable reporting and predictable results. We directed the implementation of all software platforms, and performed all vendor management actions for software companies and system integrators. For post implementation support we implemented an effective Hypercare program to support adoption of all business stakeholders.

The client had disparate technology organizations come under single leadership. There was little repeatability of process and the organizations functioned under a “personality dependent” rather than process dependent approach to serving the customer base. Many contract resources had been deployed for a lengthy time and held significant subject matter expertise and intellectual property. IT leadership desired to integrate the separate organizations, establish shared services, preserve intellectual capital, achieve process improvements, and reduce the overall contractor footprint.

Hawkins Point Partners leveraged our Assessment and Roadmap framework to assess the current situation and define the desired future state. Existing delivery artifacts were reviewed and over 80 internal resources participated in discovery. The resources included IT leadership, individual contributors, business stakeholders, and executive leadership. In additional we established an Employee Advisory Panel to support discovery and to contribute recommendations. We assessed and delivered recommendations pertaining to organizational structure, re-deployment of resources, and process improvements based on industry best practices.

After multiple attempts client had difficulty achieving the necessary project portfolio discipline and instilling effective governance processes. They needed senior leadership to immediately gain control of the booming project portfolio, perform the necessary resource planning, and ensure that the IT partners were prepared to support their growing resource needs.

Hawkins Point has developed a strong relationship with the client’s IT leadership by providing capable resources, being easy to work with, and gaining a reputation for always operating with clarity and transparency. We have provided project management services across a variety important projects that were associated with the significant growth they were experiencing. Hawkins Point was given the opportunity to lead this effort by deploying senior resources with experience at planning, managing, and delivering large and complex project portfolios for Life Sciences organizations. 

Client was growing significantly and rapidly through mergers and acquisitions. They were seeking a single partner to assume responsibility for a large portfolio of technology projects that required deep domain expertise in all operational and business areas for Health Plans. The projects required full staffing for all roles required to deliver the required business outcomes.

The Hawkins Point point team a multi-program portfolio of technology implementation projects that required deployment of project management, business analysis, and technical resources to deliver against a defined body of work. The project portfolio required integration of multiple recent mergers and acquisitions. This complex effort required deep analysis to rationalize assets, disciplined planning, and flawless execution to ensure that the portfolio was implemented with no interrupt to existing business, and that new lines of business continued to operate as expected.

The client’s objective was to gain an understanding of how to improve the commercial viability of their products via generating and analyzing Insights. Insights are generated from analyzing data from various data sources including Customer Advocacy groups, Patient feedback, Market Research, Physician Advocacy Boards, Social Listening, external/Internal Data sources. The Medical Affairs and Market Access business groups were the primary stakeholders, with Commercial Operations, Sales/Marketing, Government Affairs, Compliance, and other were other contributing business areas. 

Hawkins Point Partners leveraged our Assessment and Roadmap framework to assess the current situation and define the desired future state. We deployed deep technical and life sciences domain expertise to work with business stakeholders to effectively maps out the as-is landscape into a baseline, and define the business requirements not currently satisfied by the existing solution. We defined a Future State that was consistent with the overall business needs and achieved the organization’s vision for leveraging Insights. The recommendations provided a clear picture of process, architecture, and technology improvements to meet the needs of the business.

Client recognized there were multiple sources for common data points and a lack of authoritative data sources. There were significant issues with data quality and integrity and there was no effective data quality management function. Also, a fragmented reporting environment resulted in inconsistent outputs.

Hawkins Point evaluated information systems used by the different functional areas (Global Clinical Operations, Regulatory & Data Management) involved in the management of clinical data flow. We provided various improvements such as a standardized reporting and dashboarding mechanism across multiple sources with ad-hoc capability and a single source of truth for operational data, including current and historical data. Hawkins Point also standardized data definition, ontology and vocabulary, and designed aggregation and sematic layers with virtual, federated data marts for consistent reporting.

The client relied heavily on its enterprise data warehouse to deliver answers and insights to the business. However, the client was constrained by an enterprise data warehouse (EDW) that was fragile and inflexible. They recognized the need for a forward-looking design and was committed to establishing an EDW that is durable and flexible. However, the process of redesigning its EDW had experienced setbacks, and was lacking momentum and continuity.

Hawkins Point deployed senior Data professionals to assess the current state. We provided a reference architecture for the “to-be” EDW, ensuring the architecture and design provide a forward-looking platform for analytics, and where possible identifying risks and opportunities for improvement at all levels (process, data, technology).  We also established practical, effective data governance, in a manner that promoted trust and confidence in the EDW. We defined a technical Blueprint that leveraged on-premise technology investments, and also defined a transitional path to the Microsoft Cloud.