To stay competitive in the evolving clinical trial industry and ongoing economic environment, efficient strategies and practices need to be constantly adopted. Pharmaceutical, biotechnology, and other life sciences companies need custom-fit outsourcing models that will sustain their portfolios, facilitating successful leaps of their drug products into the market.
The strategic importance of identifying partnership models that allow short-term flexibility while providing long-term expertise is a driving factor for growth.
Navitas Data Sciences’ Functional Service Provider (FSP) Model
Navitas Data Sciences is the global Functional Service Provider (FSP) division of Navitas Life Sciences With over 25 years of experience, we support sponsors with Statistical Programming, Biostatistics, and Data Management. Supporting all clinical trial phases throughout the drug development life cycle, our blended team of data resources can help meet the future challenges of data requirements in clinical trials; either by providing complete data support, or by augmenting your existing team. Our service structure, together with our flexible and customizable FSP models, provides best-fit support that aligns to your study and your business, ensuring high-quality delivery and complying with the most rigorous standards.
In July of 2020 the AVOCA Group published a white paper on 5 challenges that affected the Sponsor and Vendor relationship, which are as follows:
- Staffing - Turnover, involvement of senior staff, not fully dedicated to one project
- Process - Alignment on SOPs, avoiding redundancy
- Communication - Effective, clear and responsive
- Transparency - Openness
- Metrics - Proper measurement
Let’s explore these 5 challenges in more detail and look at just how the Navitas Data Sciences FSP model is able to overcome them.
Challenge #1 – STAFFING:
When working with any service provider, it is important to have stability and the required expertise to engage in the developed outsourcing strategy. Here are a few facts about our Biometric FSP:
- 96% Annual Employee Satisfaction Rate (from year 2020)
- 95% Retention Rate
- 80% of our staff have over 15 years of experience
- 60% have been with NDS for over 5 years
Navitas Data Sciences has always provided skilled employees to meet needs. No matter the size and phase of the study, work is completed with the utmost precision and accuracy. The experience level of our professional resources, coupled with remote worker status, provides for an advanced, efficient, and smart work model, resulting in significant cost savings.
Challenge #2 – PROCESS:
It is important to align on SOPs and avoid redundancies. A Biometric FSP will help fill potential gaps in a clinical trial. There are 4 major areas of expertise that drive efficiencies for a successful partnership.
- Clarity in defining roles: This will help avoid redundancy, duplication, and any inconsistencies.
- Optimization of proposals: A detailed study execution plan, leveraging collective experiences, will help in optimizing study costs and timelines.
- Efficient meetings: Meetings are optimized to ensure effective use of time and to reduce discussion of similar information. A proactive approach to risk management is employed.
- Effective planning and reporting: Well-structured and standardized study tools and reports aid in coordinated information sharing.
Challenge #3 - COMMUNICATION: A clear communication strategy that is based on mutual trust, with transparent and open discussions aids in forging stellar partnerships. The environment is always conducive for working together amicably.
Challenge #4 - TRANSPARENCY: Transparency and openness are essential for strengthening partnerships.
Real-time visibility helps in overcoming potential bottlenecks, with the option to be proactive in mitigating risks. Consistent reporting in standardized formats helps in gauging site performance and lowering error rates.
- Insights to harness the full potential of outsourcing partnerships
- Incorporation of innovative approaches into the working relationship
- Enhanced trust and collaboration
- Combined effort to elevate performance
- Longer term partnerships
Challenge #5 - METRICS: Navitas Data Sciences is driven by goals and metrics that aid in supporting the needs of sponsors. Metrics include people resources, as well as factors like study planning, finances, and satisfaction and quality across functional groups.
- Key Performance Indicator (KPI) framework
- Indicator definitions
- Indicator benchmarking
- Standardized reports
- Report generation process
Navitas Data Sciences offers such efficiencies that help sponsors gain a competitive advantage, with greater trust established. Our success in providing an efficient Functional Service Provider (FSP) model for pharmaceutical and biotechnology companies is through a dedicated accent on quality and by meeting all timelines.
Navitas Data Sciences becomes an extension of the sponsor’s team by providing an FSP model and quality data that supports better regulatory submissions.