Biostatistician under FSP

• Biostatistics: Our seasoned biostatisticians, with over a decade of experience, excel in designing statistical sections for protocols, crafting detailed Statistical Analysis Plans (SAPs) with mock shells, and performing advanced sample size calculations. We guide the selection of appropriate statistical methods, offer insights on non-standard analysis techniques, and provide post-hoc analyses for publications or strategic decision-making.
• Statistical Programming: We stand ready to bolster your SAS programming team, whether to meet pressing deadlines, manage peak workloads, or navigate complex challenges. Our consultant programmers are well-versed in integrating with your team under the Functional Service Provider (FSP) model, ensuring seamless collaboration across all stages of drug development.

1. Planning a Study: We support your study from its inception, offering statistical method consultations, simulations for method performance comparison, and crucial sample size calculations.
2. Analyzing a Study: From generating CSR outputs (Tables/Listings/Figures) to implementing non-standard methods and ensuring data integrity through edit checks and cleaning, our team is adept at all facets of study analysis, including CDISC standards (SDTM, ADaM) and PK analysis.
3. Preparing an NDA/sNDA: We provide comprehensive support for integrated ISS/ISE analyses, conversion of legacy data to CDISC formats, and data harmonization efforts to streamline your NDA/sNDA preparation.
4. Post-Approval: Beyond approval, we offer exploratory and ad-hoc analyses and publication support to maximize the impact and utility of your data.

At CS Clinical, we are committed to excellence, innovation, and partnership. Our deep expertise across numerous therapeutic areas and stages of drug development enables us to meet your unique needs and objectives, ensuring your projects' success. Join us in driving forward the future of drug development.

Connect with us to discover how CS Clinical can empower your next project with cutting-edge biostatistical and statistical programming solutions.

What services does CS Clinical offer?

CS Clinical specializes in providing comprehensive biostatistics and statistical programming services under FSP contracts for the global pharmaceutical, biotechnology, and Clinical Research Organization (CRO) sectors. Our services encompass the entire drug development cycle, from planning and analyzing clinical trials to preparing New Drug Applications (NDAs) and supporting post-approval studies. We also offer advanced data science training through our Data Science Academy.

How does CS Clinical ensure the quality of its programming?

Quality is at the heart of everything we do. We go beyond mere data processing; we engage deeply with each dataset, employing sophisticated statistical methods and innovative programming techniques to extract meaningful insights. Our commitment to quality also extends to rigorous validation processes and compliance with all relevant regulatory standards.

Are CS Clinical's data and analyses recognized by regulatory authorities?

Yes, our clinical data and analyses are accepted by major regulatory authorities worldwide, including the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This recognition is a testament to our strict adherence to regulatory requirements and our commitment to maintaining the highest standards of data integrity and accuracy.

Can CS Clinical support all phases of clinical trials?

Absolutely. Our expertise covers all phases of clinical trials, from early-phase exploratory studies to late-phase confirmatory trials. We have the capabilities to assist with study design, statistical analysis, data management, and regulatory submissions across any therapeutic area.

What makes CS Clinical an ideal partner for biotechnology and pharmaceutical companies?

Our 18+ years of experience, a track record of over 300 analyzed studies, and a comprehensive suite of services make us a trusted partner in the biometrics industry. We are committed to fostering collaborative relationships, ensuring regulatory compliance, and delivering insights that drive the development of novel therapeutics. With CS Clinical, you gain a partner that is as invested in your project's success as you are.