Biostatistics and Programming - More than Just Clinical Trials
October 16, 2023
Learn how ProPharma’s Biostatisticians and Programmers enabled a small biotech company to derive more meaningful and actionable insights from their legacy data.
ProPharma's Biostatistics & Programming Expertise
At ProPharma, our biostatistics and programming team supports our clients through the entire product development journey and excels in transforming complex data into clear, actionable insights. Our global team ensures around-the-clock support and employs the latest industry standards, actively contributing to organizations like CDISC. We offer a comprehensive suite of services, from clinical study design and regulatory strategy support to clinical study execution, and provide real-time insights into what is happening with your data.
Utilizing advanced tools and languages like SAS, R, and Python, our team ensures high-quality, validated results. Our proven track record includes the successful completion of 10 NDA/BLA submissions in the past three years, demonstrating our commitment to excellence and regulatory compliance across a broad spectrum of therapeutic areas.
Clinical Study Design Services
- Endpoint Selection
- Analysis Method Determination
- Sample Size Calculations/Statistical Power (simulations, adaptive design, etc.)
- Type 1 Error Rate Adjustments
- Adaptive Design
- Protocol Development (writing and QC)
Comprehensive Biostatistics & Programming Support and Consulting
Clear Communication
We know that statistics and programming aren’t easily understood, and our team is here to help you know what’s going on with your data, in a way that makes sense and can be...
CDISC Volunteers
We ensure our clients benefit from the most current and compliant practices in the field. Our team members volunteer at CDISC to develop and refine industry standards.
Experienced with Health Authorities
Our teams have vast experience communicating with regulatory agencies worldwide, including FDA, EMA, MHRA, PMDA, Health Canada, TGA, NMPA, and more.
NDA & BLA Submission Experience
We have completed 10 NDA/BLA submissions in the last 3 years.
Global Team
Our team members are located in five countries across the globe, allowing us to work with our sponsors around the clock.
Flexible Approach
Our flexible approach allows us to support our clients in whatever model best suits their needs, whether that is full-service CRO, functional service provider (FSP), or ad-hoc...
Our Biostatistics & Programming Consulting and Services
At ProPharma, we redefine the landscape of biostatistics and programming by offering far more than mere statistical analysis. Our diverse team of experts delivers unparalleled support across the entire spectrum of the life sciences journey, ensuring that our clients benefit from a holistic and integrated approach. With best-in-class communication skills, we demystify complex statistical processes, ensuring they are accessible and transparent to all stakeholders. This approach facilitates informed decision-making at every level of engagement and fosters a collaborative environment where insights lead to innovation.
Our global, highly experienced team operates across time zones, providing around-the-clock support to our sponsors. When combined with our robust processes and global infrastructure, we accelerate project timelines and enhance quality and consistency across deliverables, significantly mitigating risks and optimizing operational efficiencies. We are flexible to support our clients with an outsourcing model that best suits their needs, including full-service CRO, FSP, or ad-hoc consulting.
Our Infrastructure & Tools
Quality and safety are at the heart of everything we do, especially when working with sensitive clinical trial data. Our team completes all work using our GXP-validated SAS server, and data is moved into and out of our environment through SFTPs.
We have programmers who are fluent in SAS, R, and Python languages, enabling us to work on any data type and conduct any data analysis needed. Our experienced team uses ProPharma's proprietary data visualization tool that enables our sponsors to view their data in real-time and to create their own graphics and dashboards providing them with key insights into their clinical trials in real-time.
Biostatistics & Programming Experts
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