Sponsors and CROs in a Functional Service Provider (FSP) model share the same objectives; to deliver the clinical study safely, effectively and efficiently. Whilst the ways in which partnerships track performance and achievement of these goals can vary across organisations, a constant fundamental assumption is that key performance indicators (KPIs) should be selected, designed and articulated so that resulting outcomes support the achievement of the sponsor’s overarching business strategy. Here, we share some best practices for KPI creation and management to ensure success in your program.
Selecting the right KPIs
In our experience, the KPIs which are most successful in driving the “right performance” are those that align both with KPIs measured internally by the Sponsor and the partnership’s objectives. This is especially true at the beginning of an FSP partnership. Orienting the teams around meaningful, shared KPIs facilitates an ease of understanding, ensures buy-in and fosters deeper collaboration across the organisations while allowing for discovery of partnership insights.
In terms of the number of KPIs, we have found that articulating and overseeing multiple performance measures does not aid transparency and can be a drain on much needed resources. We suggest sticking to those measures that directly contribute to the desired objectives, and often between six and ten measures are likely to be key for most partnerships.
In the early stages of the model, KPIs may be more tactical and focused on measures designed to understand certain logistical aspects, for example Assurance of Supply (recruitment), Operational Excellence and Delivery. Whilst we suggest committing to tracking and managing the same KPIs for about a year to create consistency in data and reporting, it is important to continuously reflect on whether those KPIs remain relevant over time. Strategies and objectives are dynamic and will change, making it inappropriate to continue to report on the same KPIs indefinitely. Equally, more data may become available that provides a deeper understanding of the workings of the program and this should result in different or additional KPIs becoming applicable.
Successfully measuring KPIs
Once the number and type of indicators are agreed, it is important to ensure they can be measured to determine successful performance and progress (or regression) toward achieving the overall program goals. To ensure your indicators will provide robust data for performance analysis, targets should follow the SMART formula:
- Specific: There should be one accepted definition of the KPI, and it should be highly visible to the relevant stakeholders.
- Measurable: The KPI should be easily quantifiable to state the actual performance versus target performance, e.g., voluntary turnover.
- Achievable: The target should be challenging but achievable. Sought after performance standards should be realistic, even if challenging.
- Relevant: Is the measure practical and pragmatic? A KPI provides more insight into performance if it is consistent with the current program context and can only be only relevant if our processes and people can influence it.
- Time framed: Values of KPIs should be expressed in a specified time frame. We suggest targets be relatively short-term measurements to ensure the appropriate tracking of program performance over the longer term.
Ensuring data quality for KPIs
Data quality is inherently tied to performance measurement. KPIs are only as good as the reliability of the data associated with them, and so a data strategy covering the following elements should be well defined from the outset:
Data source: Where does the data originate? Be as specific as possible in identifying sources, including mentioning specific directories or file names if necessary.
Data extraction moment: At which point in time is the data is fed into the KPI? Note the exact extraction moment as closely as possible, for example at noon CET or the first day of every week.
Data update frequency: How often is the data refreshed per period? Determine if the data is real-time, weekly or bi-weekly, etc.
Data supplier: Which individual or department is responsible for delivering the source data?
KPI owner: Which individual is ultimately responsible for KPI availability and accuracy? A named owner encourages accountability and responsibility.
Data reporting and visualisations
Data reporting is critical as it is the first step toward decision-making and acting on this information in a way that improves performance and drives better outcomes. A clear strategy should include how often and to whom data will be reported and should account for the different reporting needs of each measure and responsible team.
Below is a graphical representation of how data can flow within a program governance structure:
Data visualisations can also give life to goals and make progress tangible for teams. Some of our partners have availed of the services of our ICON Data Analytics team to create a dynamic, balanced scorecard. While no measurement is perfect or complete, creating meaningful visual data comparisons enables deeper interpretation and better decisions by teams. In addition, visualising performance over time enables us to identify trends which provides useful context in assessing underlying progress/successes.
Responsive KPIs for dynamic partnerships
These best practices for KPI management will help guide robust partnership controls to improve efficiencies. If planned, managed and expressed well, KPIs tell us how well the program is operating across different areas and can inform timely decision-making processes to direct appropriate actions. In so doing, we drive partnership growth and ensure performance alignment with our sponsor’s overarching objectives.
Authored by: Triona Price Smith
In this section
-
Digital Disruption
-
Clinical strategies to optimise SaMD for treating mental health
-
Digital Disruption whitepaper
- AI and clinical trials
-
Clinical trial data anonymisation and data sharing
-
Clinical Trial Tokenisation
-
Closing the evidence gap: The value of digital health technologies in supporting drug reimbursement decisions
-
Digital disruption in biopharma
-
Disruptive Innovation
- Remote Patient Monitoring
-
Personalising Digital Health
- Real World Data
-
The triad of trust: Navigating real-world healthcare data integration
-
Clinical strategies to optimise SaMD for treating mental health
-
Patient Centricity
-
Agile Clinical Monitoring
-
Capturing the voice of the patient in clinical trials
-
Charting the Managed Access Program Landscape
-
Developing Nurse-Centric Medical Communications
- Diversity and inclusion in clinical trials
-
Exploring the patient perspective from different angles
-
Patient safety and pharmacovigilance
-
A guide to safety data migrations
-
Taking safety reporting to the next level with automation
-
Outsourced Pharmacovigilance Affiliate Solution
-
The evolution of the Pharmacovigilance System Master File: Benefits, challenges, and opportunities
-
Sponsor and CRO pharmacovigilance and safety alliances
-
Understanding the Periodic Benefit-Risk Evaluation Report
-
A guide to safety data migrations
-
Patient voice survey
-
Patient Voice Survey - Decentralised and Hybrid Trials
-
Reimagining Patient-Centricity with the Internet of Medical Things (IoMT)
-
Using longitudinal qualitative research to capture the patient voice
-
Agile Clinical Monitoring
-
Regulatory Intelligence
-
An innovative approach to rare disease clinical development
- EU Clinical Trials Regulation
-
Using innovative tools and lean writing processes to accelerate regulatory document writing
-
Current overview of data sharing within clinical trial transparency
-
Global Agency Meetings: A collaborative approach to drug development
-
Keeping the end in mind: key considerations for creating plain language summaries
-
Navigating orphan drug development from early phase to marketing authorisation
-
Procedural and regulatory know-how for China biotechs in the EU
-
RACE for Children Act
-
Early engagement and regulatory considerations for biotech
-
Regulatory Intelligence Newsletter
-
Requirements & strategy considerations within clinical trial transparency
-
Spotlight on regulatory reforms in China
-
Demystifying EU CTR, MDR and IVDR
-
Transfer of marketing authorisation
-
An innovative approach to rare disease clinical development
-
Therapeutics insights
- Endocrine and Metabolic Disorders
- Cardiovascular
- Cell and Gene Therapies
- Central Nervous System
-
Glycomics
- Infectious Diseases
- NASH
- Oncology
- Paediatrics
-
Respiratory
-
Rare and orphan diseases
-
Advanced therapies for rare diseases
-
Cross-border enrollment of rare disease patients
-
Crossing the finish line: Why effective participation support strategy is critical to trial efficiency and success in rare diseases
-
Diversity, equity and inclusion in rare disease clinical trials
-
Identify and mitigate risks to rare disease clinical programmes
-
Leveraging historical data for use in rare disease trials
-
Natural history studies to improve drug development in rare diseases
-
Patient Centricity in Orphan Drug Development
-
The key to remarkable rare disease registries
-
Therapeutic spotlight: Precision medicine considerations in rare diseases
-
Advanced therapies for rare diseases
-
Transforming Trials
-
Accelerating biotech innovation from discovery to commercialisation
-
Ensuring the validity of clinical outcomes assessment (COA) data: The value of rater training
-
Linguistic validation of Clinical Outcomes Assessments
-
Optimising biotech funding
- Adaptive clinical trials
-
Best practices to increase engagement with medical and scientific poster content
-
Decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
Decentralised and Hybrid clinical trials
-
Practical considerations in transitioning to hybrid or decentralised clinical trials
-
Navigating the regulatory labyrinth of technology in decentralised clinical trials
-
Biopharma perspective: the promise of decentralised models and diversity in clinical trials
-
eCOA implementation
- Blended solutions insights
-
Implications of COVID-19 on statistical design and analyses of clinical studies
-
Improving pharma R&D efficiency
-
Increasing Complexity and Declining ROI in Drug Development
-
Innovation in Clinical Trial Methodologies
- Partnership insights
-
Risk Based Quality Management
-
Transforming the R&D Model to Sustain Growth
-
Accelerating biotech innovation from discovery to commercialisation
-
Value Based Healthcare
-
Strategies for commercialising oncology treatments for young adults
-
US payers and PROs
-
Accelerated early clinical manufacturing
-
Cardiovascular Medical Devices
-
CMS Part D Price Negotiations: Is your drug on the list?
-
COVID-19 navigating global market access
-
Ensuring scientific rigor in external control arms
-
Evidence Synthesis: A solution to sparse evidence, heterogeneous studies, and disconnected networks
-
Global Outcomes Benchmarking
-
Health technology assessment
-
Perspectives from US payers
-
ICER’s impact on payer decision making
-
Making Sense of the Biosimilars Market
-
Medical communications in early phase product development
-
Navigating the Challenges and Opportunities of Value Based Healthcare
-
Payer Reliance on ICER and Perceptions on Value Based Pricing
-
Payers Perspectives on Digital Therapeutics
-
Precision Medicine
-
RWE Generation Cross Sectional Studies and Medical Chart Review
-
Survey results: How to engage healthcare decision-makers
-
The affordability hurdle for gene therapies
-
The Role of ICER as an HTA Organisation
-
Strategies for commercialising oncology treatments for young adults
-
Blog
-
Videos
-
Webinar Channel