Comprehensive Statistical and Programming Services

The Griesser Group offers a complete range of Statistics and Statistical Programming deliverables, providing clients with comprehensive solutions for every phase of pharmaceutical and biotech development. From statistical designs, statistical analysis plans, data analysis, and reporting, our expert team ensures accuracy, regulatory compliance, and timely results, helping to drive successful product submissions and market approvals.

The Griesser Group

Our Core Services

Statistical Sections of Protocols

We offer expert development of the statistical sections of study protocols, ensuring that statistical methods and analyses are robust, clear, and aligned with regulatory standards.

Statistical Analysis Plans

Our team crafts detailed Statistical Analysis Plans (SAPs), outlining the methodologies, procedures, and techniques for analyzing clinical trial data, ensuring consistency and regulatory compliance throughout the study.

Clinical Programming of Tables/Listings/Graphs

We provide efficient and precise clinical programming services for tables, listings, and graphs (TLGs), transforming complex clinical data into clear, meaningful outputs that meet regulatory requirements.

Interpretation of Results via Statistical Reports

Our expert statisticians analyze clinical data and provide in-depth statistical reports, interpreting results clearly and concisely to support informed decision-making and regulatory submissions.

Preparation of CDISC SDTM and ADaM Datasets

We specialize in preparing SDTM and ADaM datasets in compliance with CDISC standards, facilitating efficient e-submissions, and supporting the regulatory approval process.

 

Statistical Representation with Regulatory Agencies

Our team is experienced in representing your statistical data during discussions with regulatory agencies, ensuring your submissions meet the highest standards and regulatory expectations.

Consultation in Statistics and Clinical Programming

Our experienced team offers comprehensive consultation services across statistics and clinical programming, providing expert guidance throughout the pharmaceutical development process.

Optimize Your Pharmaceutical Development

Whether you need expert statistical analysis or clinical programming, our team is here to guide you. Reach out to us for a consultation and discover how our services can streamline your process and ensure regulatory success.