In clinical research, efficiency and quality are key. As the industry continues to grow, Functional Service Provider (FSP) models are gaining popularity for their ability to streamline operations and provide specialized services. As a leading CRO, Navitas Life Sciences also offers robust FSP services that can enhance the efficiency and outcomes of clinical research, including Statistical Programming in SAS and R, Biostatistics, and Data Management.
In this blog, we will explore the benefits of Navitas Life Sciences' FSP data services and how they can be instrumental in driving success for your clinical trials.
According to the McKinsey Global Institute, employing big-data strategies to guide decision-making processes could result in up to $100 billion in annual value across the US healthcare system. This potential value can be unlocked by enhancing research and clinical trial efficiency, fostering innovation, and creating new tools for healthcare professionals, consumers, insurers, and regulators. These advances align with our mission at Navitas Life Sciences to provide robust, data-driven solutions that support successful outcomes in clinical trials.
Top-Tier Support Since 1993
Our skilled experts in Statistical Programming, Biostatistics, and Data Management drive successful clinical trial outcomes for our sponsors. Our Biometrics capabilities encompass all phases of the drug development life cycle, ensuring seamless support every step of the way. Our dedicated team of professionals power every FSP engagement, propelling our sponsors toward their goals. Whether you need comprehensive data support or an enhancement to your current team, our FSP is ready to help you navigate future challenges in clinical trial data deliverables.
What is the FSP Model?
The FSP model involves sourcing specific functions within a clinical trial, such as programming, biostatistics, and data management. This approach enables sponsors to focus on core competencies while leveraging the expertise of FSPs to handle specialized tasks.
Benefits of Navitas Life Sciences' FSP Data Services
Navitas Life Sciences brings several advantages to the table as an FSP provider, including:
1. Access to Specialized Expertise:
Navitas Life Sciences has a strong track record of delivering high-quality services. Our team of experts, which includes 110+ US and 70+ India-based experts, is well-versed in the nuances of clinical research and can provide tailored solutions to meet the needs of your trial.
Our team is encouraged to collaborate with outside organizations including, but not limited to, PHUSE, PharmaSUG, and CDISC, to ensure that they have a pulse on the latest in the industry.
Feedback from the Director, Statistical Programming- Top 50 US Pharmaceutical Company
“I would like to take this opportunity to thank each one of you for making this deliverable in record time with quality. As you all know the importance of this critical pivotal study for needed patients and our company, you all have performed at your best with a lot of composure, and consistently excelled at all levels to reach this far. Your dedication and perseverance are top-notch. I am very happy with the team’s skillset, dynamics, hard work, flexibility, and leadership. I have received consistent positive feedback from our stakeholders. Keep up the good work!! Thanks again.”
2. Scalable and Flexible Resources:
With the FSP model, you can scale your operations based on your size and requirements. Navitas Life Sciences can quickly adapt to your needs, whether you're working on a single study or a large-scale clinical trial.
With 30 years of expertise, we build bespoke, client-specific, dedicated teams of statistical programming experts for our sponsors.
Feedback from Associate Director, Statistical Programming- Top 50 US Pharmaceutical Company
“We want to thank all of you for your commitment and hard work to meet the timelines and create high-quality work. Thank you for all the long hours, weekends, and dedication to see these results being delivered. A big thank you to the leadership and all the programmers from other groups who helped us when we were at a crunch time. THANK YOU!”
3. Cost-Effective Solutions:
Outsourcing data services to Navitas Life Sciences offers a cost-effective solution. Our FSP Model operates under a T&M billing scheme, reducing overhead costs. We embed a dedicated team that acts as a true extension of your organization.
4. Enhanced Flexibility:
The FSP model offers greater flexibility, enabling you to adjust the level of service according to your changing needs. Navitas Life Sciences can tailor their support to match the evolving demands of your trial.
Feedback from the Executive Director, Clinical Data Sciences- US Biotechnology Company
“First, I want to commend and recognize the quality of the work and the flexibility you all have demonstrated. Thank you all very much. Please extend my sincere gratitude back to everyone in India. We’re off to a great start”
5. Compliance and Quality Assurance:
Navitas Life Sciences prioritizes compliance with industry standards and regulations, ensuring data accuracy and integrity. Their robust quality assurance processes help maintain high-quality data throughout the trial. We follow client processes and SOPs.
Feedback from Director, Statistical Programming- Top 10 US Pharmaceutical Company
“We received notification today from Regulatory that the Supplemental Biologics License Application (sBLA) has received FDA APPROVAL today. I would like to extend my congratulations and thank you to the Navitas programming team who worked tirelessly to support this! This is fantastic news! A huge accomplishment for the team!”
How Navitas Life Sciences Can Drive Your Clinical Research Success
Navitas Life Sciences' FSP data services provide the support you need to enhance the efficiency and effectiveness of your clinical trials. By leveraging our expertise and flexible, scalable solutions, you can focus on the critical aspects of your research while leaving specialized tasks to our team of professionals.
Statistical Programming in Clinical Trials
Statistical programming is a crucial component of clinical research, involving the development and implementation of algorithms to analyze and interpret trial data. In the context of FSP, statistical programmers at Navitas Life Sciences play a vital role in ensuring accurate and reliable data analysis.
- Project Management
- SAS & R Programming
- RWE/RWD Programming
- SDTM & ADaM Mapping & Generation
- Define.xml Generation
- Tables, Listings, & Figures (TLFs)
- Analysis Dataset Programming
- Ad hoc Analysis Programming
- Statistical Analysis Programming
- QC & Verification Programming
- PK|PD Programming & Analysis
- CSR, ISS/ISE, & Annual Report Support
- Registry, Post Marketing, & Manuscript Support
- SAS Macro Development
Biostatistics in Clinical Trials
Biostatistics and clinical trials have a fundamental association in clinical research, providing the statistical foundation for study design, data analysis, and interpretation. Navitas Life Sciences offers comprehensive biostatistics services tailored to the specific needs of each trial. Our team of biostatisticians work closely with clients to design robust study protocols, conduct statistical analyses, and provide expert consultation throughout the trial life cycle.
Whether it's statistical analysis, statistics consulting, or implementing statistical methods, our focus is on ensuring the highest standards of statistics in every project we undertake. As a trusted biostatistics FSP, Navitas Life Sciences is dedicated to delivering reliable and insightful biostatistics services to support the success of clinical trials and advance medical research.
- Project Management
- Full Clinical Study Planning, Execution, & Reporting
- Protocol Development & Study Design
- Sample Size, Power Estimation, Randomization, & Statistical Methods
- Statistical Analysis Plan & TLF Shells
- Analysis Dataset & ADaM Specifications
- Data Reviews, Analysis, & Interpretation
- ISS/ISE Development & Analysis
- Registry Study Support
- PK/PD Support
- Publication Support
- Epidemiology Support
- Annual Reporting to Regulatory Authorities (FDA & EMEA)
- Ongoing Maintenance of Data & Communications with Team
Data Management FSP
Effective data management is essential for the success of any clinical trial. FSP data management services provided by Navitas Life Sciences encompass a range of activities, including database design, data cleaning, and quality control. Our data management experts ensure that trial data is collected, stored, and analyzed accurately and securely, adhering to industry standards and regulatory guidelines.
- Project Management
- Database & eCRF Design, Edit Checks, Programmed Dynamics, & UAT
- EDC Platform Development: InForm, Medidata RAVE, Veeva Vault, Medrio, & OpenClinica
- Programmed Standard & Smart Data Listings
- Data Quality, Data Cleaning, & Query Resolution
- SAE Reconciliation/External Data Reconciliation
- External Vendor & Project Team Management
- Document Creation including DVS, DMP & Data Entry Guidelines
- Audit Readiness & Study Documentation Management
Leveraging SAS Programming for Clinical Trials
SAS programming in clinical trials is widely used for data analysis and reporting. Navitas Life Sciences has extensive experience in SAS programming for clinical research, offering a range of services to support efficient and compliant trial execution. SAS programming projects are handled by experts to create value and to support the needs of the sponsors. With the introduction of open source, Navitas Life Sciences also supports R programming.
FSP Data Services provided by Navitas Life Sciences offers a comprehensive solution for organizations seeking to optimize their clinical trials. By leveraging Statistical Programming, Biostatistics, and Data Management expertise, we enable clients to conduct trials more efficiently, accurately, and cost-effectively. Whether it's designing analysis datasets, cleaning and managing trial data, or conducting complex statistical analyses, our team of experts is committed to delivering high-quality solutions that drive success in clinical research.
Navitas Life Sciences is a trusted partner in delivering exceptional FSP services. Our commitment to quality and cost-effective solutions will help drive success for your clinical research projects. Explore how Navitas Life Sciences' FSP model can benefit your next clinical trial and pave the way for impactful clinical trial outcomes.
A Global FSP helping you to meet the challenges of data requirements in clinical trials
With over 25 years of expertise, we offer comprehensive support in Statistical Programming, Biostatistics, and Data Management for sponsors. Covering all phases of the drug development life cycle, our skilled data teams are equipped to handle the evolving demands of clinical trials, offering complete data services or team augmentation.
Our adaptable service structure and customizable FSP models provide tailored support that aligns with your goals, delivering high-quality results and adhering to strict standards.
Access our brochure and discover how we can help you navigate the challenges of clinical trial data requirements.
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