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Validation, Predictive/Prescriptive Embedded and Advanced  Analytics (AI/ML)

Publicly Traded, Leading Medical Device Company

Challenge

Customer needed a validated, advanced analytics BI solution for Complaints and eMDR submissions as well as preparation for FDA Audits. The intended use was to make product quality decisions in the manufacturing of their devices.

Solution

Acumen performed full validation on customer platform authoring and executing all protocols and provided purpose-built dashboards with interactive data visualizations and integrated data from quality and manufacturing systems optimizing it for analytics and reporting. We delivered a fully validated GxP full stack advanced analytics end reporting system which included an enterprise class data visualization tool as a component of the overall solution.

 

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Data Analytics

Leading Multinational Pharmaceutical Company

Challenge

This project was for risk management and regulatory compliance for US government departments and international reporting agencies, USDA, FDA, EPA and IACUC. It demonstrates Acumen's ability to work in the public sector and our significant experience with regulatory compliance. In addition, there was a significant amount of proprietary and confidential information handled demonstrating Acumen's deep expertise with sensitive data.

Solution

Acumen interacted with each of the data “owners” over many months, including procurement department, clinical discovery staff and principal investigative staff, to clearly map the current process for all data tied to the animals and chemicals lifecycle. The customer was then able to make a change to the data entry procedures to ensure simple mistakes in data entry were caught immediately. Data integrity was greatly improved, leading to more accurate analysis.

 

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Data Analytics, Data Engineering and Modeling

Fortune 100 Global Human Resources Consulting Firm

Challenge

Customer needed ability to determine degree of employee engagement for their clients in a consistent manner with year over year comparisons to replace their sporadic, one-off approach

Solution

Built an analytics platform using data visualization and augmented analytics that allowed end users to interactively assess employee engagement across various departments and sites using statistical analysis and natural language processing. Create process for survey launch and automated data collection.

Provided solution for consistent survey execution with year over year comparison and analysis that anonymized employee feedback.

 

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Advanced Analytics

US Healthcare Data Technology Vendor

Challenge

Customer was unable to effectively gather and categorize data about individual episodes of care to use in their SaaS health payment solution.

Solution

Acumen embedded analytics into the existing customer solution with interactive data visualizations to determine efficiency, cost and time for each episode of care. Using data from public sources and individual hospital systems, information was gathered about individual episodes of care. Episodes of care were categorized allowing health systems to attain information about patients, doctors and procedures to identify potentially avoidable patient complications. Our team transformed the customer’s SaaS health payment solution to provide analytics in real time enabling the solution to be more efficient.

Acumen provided a means for the customer to visualize patient data to improve overall performance by taking data driven actions based on real time reporting and advanced analytics. The customer’s success led to acquisition by a leading global healthcare technology company.

 

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Data Analytics

Leading Global Contract Manufacturer for Medical Devices

Challenge

Unable to effectively ascertain specific key performance indicators and trend analysis across multiple quality processes within the organization in a timely manner

Solution

Provide single version of truth solution that allowed customer to access near real-time data with insights into CAPA, Change Management, Complaints, Document Control, Training and Supplier Management without negative impact on QMS system

 

 

Pharmaceutical Company Leveraging Real World Data
Pharmaceutical Company Leveraging Real World Data

Advanced Analytics & Data Engineering

Combining Real World Data and Analytics to Bring Drug Therapies to Market

Challenge

Gaps gathering information about current and future drug therapies for patient treatment, market cohorts and market potential.

Solution

AI, ML and advance analytics combined with Real World Data to provide better understanding of patient cohorts and market potential. Created ability to characterize, quantify and provide insights to historical patient journeys and potential therapeutic options enabling an effective pricing strategy for phase 3 drug.

 

 

Medical Device Bespoke Analytics Platform
Medical Device Bespoke Analytics Platform

Data Migration & Data Harmonization

Supplier Quality Harmonization for a Leading Medical Device Manufacturer

Challenge

Lack of optimized and centralized Supplier Quality data for analytics necessary to improve Supply Chain performance.

Solution

Data warehouse modeling, optimization & harmonization to combine data and enable advanced analytics for Supply Chain improvement opportunities. Migrated data from multiple legacy systems including Supplier and Materials, Supplier Quality Scorecard, Audits Management, & Supplier Corrective Actions

 

 

Clinical Diagnostics Laboratory Analytics
Clinical Diagnostics Laboratory Analytics

Embedded Analytics & Advanced Analytics 

Clinical Diagnostic Laboratory Analytics

Challenge

Performance of clinical diagnostic labs in large healthcare facilities was not meeting standards, human and equipment resources were not being used efficiently.

Solution

Creation of a multi-tenant solution that transformed the customer’s SaaS laboratory solution by providing advanced analytics in real time.  Embedded analytics into the existing customer SaaS laboratory solution allowing data to flow from diagnostic equipment management systems to an analytics repository. This enabled the customer to identify opportunities for improvement in staffing, process and quality.  Data visualizations helped the customer make data-driven decisions to optimize utilization of diagnostic equipment, ensure appropriate test ordering and improve turnaround time.

The insights it provided resulted in reduced waste and increased efficiency, driving financial and operational value back to the lab. The customer’s success led to acquisition by (Roche) a leading global biotech company.

 

 

Global Chip Manufacturer Case Study
Global Chip Manufacturer Case Study

Advanced Analytics & Data Engineering

Insights for a Leading Global Semiconductor Company

Challenge

Customer needed actionable insights for the following processes: Product Lifecycle Management, Statistical Process Control, Audits Management, Change Management and Corrective Action

Solution

Modeling, Optimizing & Harmonizing data from manufacturing and service facilities around for a single version of truth and data analytics in conjunction with Quality Management System.

Custom dashboards using data visualizations for real time analytics.

 

 

Plant Based Biotech Case Study
Plant Based Biotech Case Study

Validation as a Service / Process Automation

A Global Company Dedicated to Making Affordable Medicine

Challenge

To help get medicine to underserved areas of the world and underserved biologics markets by producing affordable medicine on a scale that will alleviate global production capacity limitations.

Solution

Acumen partners with Biotech to deliver a revolutionary SaaS platform enabling drug development and manufacturing to empower underserved areas of the world leveraging AI, Machine Learning, Blockchain and Digital Twin technologies

 

 

Quality Management Case Study
Quality Management Case Study

Embedded Analytics

Insights for Global Quality Management Application

Challenge

The current QMS system did not provide robust data analytics for end users.

Solution

Acquisition of Acumen Analytics Optimal Insights - A multi-tenant SaaS analytics platform providing near real time analytics enabling quality, data-driven decision making for over 450 of the most influential companies worldwide——in all types of industries, including five of the top Global Life Sciences companies and four leaders in the medical device industry.

 

 

Clinical Trial Analytics Case Study
Clinical Trial Analytics Case Study

Embedded Analytics

Embedded Analytics in a SaaS Clinical Trial Solution resulting in Acquisition

Challenge

Inefficient process for clinical trial participation resulting in lagging enrollment

Solution

Transformed customer’s SaaS clinical trial solution to provide advanced analytics in real time that accelerated the clinical trial selection and activation. The customer’s success led to acquisition by (Oracle Health Sciences) the leading global healthcare cloud solution provider.

 

 

Leader in moving walkways and elevators case study

Advanced Analytics & Data Engineering

Insights for world class leader in elevators escalators & moving walkways.

Challenge

Customer needed a means to analyze in-field part defects and resolutions across multiple manufacturing sites and service facilities.

Solution

Modeling, Optimizing & Harmonizing data from manufacturing and service facilities around for a single version of truth and data analytics in conjunction with Quality Management System.

Custom dashboards using data visualizations for real time analytics to enable proactive measures to improve quality and contain cost.

 

 

Fortune 100 Global Biologics Manufacturer
Fortune 100 Global Biologics Manufacturer

Data Engineering Performance Optimization

Fortune 100 Global Biologics Manufacturer

Challenge

Analytical reports took too long to run negatively impacting their daily quality management operations.

Solution

Acumen assessed the technical architecture of their reporting system and analyzed configuration of their reporting tools.  Re-architected data repositories and optimized reporting methods resulting in significant improvement in response times.