|Benchmarking and Quality Best Practices
Best Practices, LLC has conducted extensive research in the field of Benchmarking and Quality. Browse through and sample our published Benchmarking and Quality research in the topics below:
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|Benchmarking BioPharma Quality and CAPA Processes: Quality Resource Management|
Non-members: Click here to review a complimentary excerpt from "Benchmarking BioPharma Quality and CAPA Processes: Quality Resource Management"
Biopharmaceutical companies spend millions to ensure their products meet Quality standards at every stage of the product life cycle, from R&D to post-market activity.
Facing tight budgets and escalating regulations, Quality leaders walk a tight rope in balancing quality and safety while managing costs and assessing risk. Across the myriad Quality activities, where are leaders currently spending the most? How do Quality leaders expect spend to change during the coming years across a key set of quality activities? What factors are driving cost of quality?
Research and consulting leader Best Practices, LLC undertook a new study to answer these questions and more. Topics addressed in this study include: how companies define and allocate Quality spend, and factors that impact spending levels. Leaders can use this research to compare their levels of spend across key Quality areas with their peers.
This study presents two segments on some questions: All Participants and Large Companies
Quality Spend Levels and Trends
Quality Spend Mix
Quality Reporting and Ownership
Quality Spend Drivers
Best Practices for a Robust Quality Function
SAMPLE KEY METRICS
Percentage of total quality function budget allocated to these critical quality channels (compliance, nonconforming, etc.)
Expected change in allocations to quality budget for these key channels (compliance, nonconforming, etc.)
Total spend of quality function in 2014
Quality spend inclusions and exclusions for 2014
Actual and desired percentage of resources allocated to these cost of quality categories (appraisal, prevention, etc.)
Categories used when reporting cost of quality
Role (lead, support, none) of these key functions in cost of quality budgeting and ownership
Impact of these factors on increasing the cost of quality
SAMPLE KEY FINDING
Quality Spend Mix: Benchmarked companies have a critical improvement area for allocating higher percent of their quality budget to prevention and this change may decrease budget allocated to appraisal activities and external failures.
Quality Reporting and Ownership: It’s important for companies to align quality ownership with quality budget management. As the functions that have the ownership of quality activities obtain more financial resources and responsibilities, budget allocation to several activities will be more effective.
Best Practices, LLC recruited Quality function and CAPA Process executives at 14 biopharmaceutical organizations to share their data and insights in a customized benchmarking study.
Best Practices in Globalizing MSL & Field-Based Medical Specialist Programs: Resources and Global Standards
Non-members: Click here to review a complimentary excerpt from "Best Practices in Globalizing MSL & Field-Based Medical Specialist Programs: Resources and Global Standards"
Biopharmaceutical organizations are increasingly adopting global MSL & Field-Based Medical Specialist (FBMS) programs to achieve corporate goals within regional markets. However, medical affairs leaders often face difficulties in effective global deployment of MSLs and other FBMS.
Best Practices, LLC undertook a benchmarking study to assist medical affairs leaders in achieving functional excellence in MSL globalization. The study looks at the resources and global standards that drive success in globalizing field medical teams. It includes benchmarks and insights around span of control, MSL to KOL ratios, outsourcing trends and establishing global standards for field teams while recognizing regional needs.
This study will allow medical affairs leaders to compare their company's resourcing and standards for global field based medical teams with other peer organizations.
Resources for MSL & Field-Based Medical Specialist Programs
Global Standards & Policies
Benchmark Participant Demographics
SAMPLE KEY METRICS
Percentage of Funding for the MSL/FBMS Program Budget Received from Different Functions
MSL/FBMS Budget Location
MSL/FBMS Budget Allocation
Average Number of Direct MSL Managers
Average Number of FTEs Overseen by Each Direct Manager of MSL/Field-Based Medical Specialists
Average Number of KOLs per MSL/FBMS
Current and Past Outsourcing of MSL/FBMS Function
Best Methods for Determining No. of Specialists to be Put into Field
Medical Specialist Deployment Method Effectiveness
Global Services Uniformity
MSL Service Differentiation by Region
Approach to Developing Global Policies for MSLs/FBMSs
Obstacles to Implementing Global Standards
SAMPLE KEY FINDING
Global MSL Service Standardization: Only 16% of participants have no approach for standardizing MSL service across all markets, while the rest take at least one approach to developing global policies for MSLs. Among key obstacles to standardization are local resistance, local misunderstanding of the MSL function, decentralization, variations in local regulations, and differences in customs, language, or culture.
Thirty-eight leaders of Medical Science Liaison (MSL) and Field-Based Medical Specialist (FBMS) functions at 31 different pharmaceutical, biotech, and medical device companies participated in this study. Results include more than one response from seven companies, where survey participants represented separate MSL organizations.
Medical Affairs’ Role in Health Economics & Outcomes Research within Oncology
Non-members: Click here to review a complimentary excerpt from "Medical Affairs' Role in Health Economics & Outcomes Research within Oncology"
As payers and consumers increasingly seek patient outcomes data and clinical evidence supporting the product, biopharmaceutical companies are turning to their medical affairs function to effectively streamline the dissemination of medical information.
Development of strong health outcomes (HO) capabilities within Medical Affairs (MA) organizations requires an increase in MA’s involvement with HO groups, development of field-based HO capabilities, customization of HO data by stakeholders, and building real world data capabilities to generate and utilize HO information.
Best Practices, LLC conducted this study to help companies focused on oncology therapies find better ways to develop successful Health Outcomes groups. This research delivers current data and best practices from Medical Affairs leaders with an oncology focus at top biopharmaceutical companies.
• Longevity of HO Groups
• HO Leadership
• HO Reporting Structure
• HO Group Staffing
• MA’s Role in HO Activities
• MA’s Role in Collecting HO Data
• Utilization of HO Data
• Impact of HO Data on Decisions
• Length of Health Outcomes (HO) Programs
• HO Leadership Within Benchmark Class
• Reporting Structure: To whom does the Health Outcomes group(s) report?
• Number of Field and Office Based HO’s FTEs
• Percentage of Field-Based HO FTEs
• Core Field-Based HO Responsibilities
• Medical Affair’s Involvement in HO Activities
• Medical Affair’s Role in Collecting HO Data
• Utilizing the Health Outcomes Data To Inform Patients
• Utilizing the Health Outcomes Data To Inform Payers
• Utilizing the Health Outcomes Data To Inform Providers
• Effect of HO Data on Critical Decisions
SAMPLE KEY FINDINGS
• Longevity of HO Groups: HO programs are common, but they represent a young initiative for many of the benchmark class; sixty percent of companies have had it in place for less than three years.
• Reporting Structure: 60% of companies’ HO groups report to Medical Affairs. A majority of the interviewed executives think that HO groups must report to a science and research oriented department such as clinical or medical affairs. Between these two, medical affairs provides better opportunities for needs assessment, communicating HO data insights, and interacting with key decision makers.
Best Practices, LLC engaged 10 executives from leading life sciences companies. The analysis is focused on companies with oncology therapies.