At Premier Research we understand that the success of any trial is measured by the quality, accuracy, and integrity of its data. That’s why our Biostatistics and Clinical Data Sciences teams work in seamless collaboration, ensuring a consistent flow of high-quality data from study design through regulatory submission.

By integrating statistical expertise, data management, and advanced analytics, we help sponsors make informed decisions faster, reduce risks, and accelerate study timelines.

Biostatistics: Expert Analysis for Smarter Study Design and Delivery

Our biometrics professionals begin with the end in mind—incorporating efficiencies throughout a project and tailoring needs to meet desired outcomes. Our comprehensive services assure optimized trial design, regulatory compliance, and data integrity. We prioritize the seamless flow of quality data from study design through submission.

Our veteran biostatistics professionals work closely with you at every step, using technical, scientific, and industry expertise to support trial design, statistical analysis, and reporting. Early in study planning, they work collaboratively with cross-functional project teams to offer consulting and guidance on sample size, randomization methods, and clinical endpoints.

Our Strategic Solutions:

• Innovative Trial Design and Analysis: Statistical consulting services for innovative trial design, study synopsis development, advanced statistical methods (including adaptive and seamless clinical trials, modeling and simulation, Bayesian methods, multiple imputation with pattern mixture models, dose response modeling, RWD analytics, etc.), and marketing study support
• Strategic Study Design and Sample Size Optimization: Comprehensive clinical development planning from proof of concept to Phase III including opportunities for seamless study design consisting of individual protocol design, endpoint selection, and sample size calculation through clinical study report (CSR) writing and review
• Seamless Cross-Functional Collaboration: Cross-functional integration throughout the full project plan, including database design and setup and report development
• Regulatory Submission Expertise: Experienced in planning and executing Integrated Summaries of Safety and Efficacy (ISS/ISE) to support NDA submissions with advanced knowledge of Clinical Data Interchange Standards Consortium (CDISC) standards and requirements to ensure new drug application (NDA) submission-ready data
• Proficient Safety Reporting: Extensive proficiency in data and safety monitoring board (DSMB) output, interim analysis, and investigational new drug (IND) safety updates
• Diverse Therapeutic Area Experience: Deep and varied regulatory filing experience spanning dermatology, a variety of rare/orphan diseases, oncology, central nervous system, analgesia, gastrointestinal, and medical device

Data Management: Ensuring Data Accuracy and Compliance

The seasoned data management experts on our Clinical Data Sciences team provide a full complement of services to ensure accurate data collection, validation, and cleaning, reducing study risks and advancing clinical development with precision. With a rigorous approach to data management, we strive to quickly address any issue that arises, providing clean, robust real-time insights to drive informed decisions and guide your drug swiftly through development.

Our Clinical Data Sciences Team Support:

• End-to-End Data Management: We design and validate the study database based on study specifications, and develop data capture tools in accordance with all regulatory and study requirements.
• Seamless Data Integration: We coordinate data integration efforts to support cross-functional, risk-based review  to detect and address issues early.
• Advanced Data Validation & Cleaning: Our team will carry out rigorous data cleaning procedures to ensure data is accurate, complete, and regulatory ready.
• Medical Coding and Adverse Event Reconciliation: Our experts support consistent safety monitoring, medical coding, and reconciliation and regulatory reporting of serious adverse events.

Support from Premier IRT  

Our clinical data sciences and biostatistics teams are supported by Premier’s Interactive Response Technology (IRT) system that simplifies clinical trial management, improves data security, and easily accommodates your specific study design requirements. Learn more about how our approach allows you to automate your trial with flexibility and confidence. 

Why Choose Premier Research for Biostatistics & Data Management? 

• An Integrated Approach: Ensuring seamless collaboration between Biostatistics & Clinical Data Sciences to maintain data quality from study setup to submission. 
• Regulatory Confidence: Deep expertise in CDISC compliance, NDA submissions, ISS/ISE execution, and DSMB reporting. 
• Accelerated Timelines: Optimized data collection, monitoring, and statistical analysis to streamline decision-making. 
• Therapeutic Area Expertise: Proven success across diverse indications, including rare diseases, oncology, CNS, and medical devices. 

With Premier Research, you gain a data-driven partner dedicated to delivering regulatory-ready insights and superior data quality. Contact Premier today to discuss how we can optimize your study together.