Services
Study Design
Pentara offers expert statistical advice for clinical trials, focusing on optimal study design. We provide customized strategies for efficacy and safety to power studies effectively, and assist in selecting appropriate outcomes for regulatory approval. We use historical data and literature to enhance study success, communicate complex results clearly, and integrate statistical perspectives throughout the clinical trial process to maintain study power and integrity.
Study Design ServicesClinical Programming
To maintain high industry standards for our work with both SDTMs and ADaMs, Pentara requires all programmers to be SAS certified. Even our summer interns get their SAS certifications.
Clinical Programming ServicesData Management
Pentara provides comprehensive clinical data management, ensuring the highest quality, integrity, and security for client data. Our services include EDC database setup, ongoing data review, and thorough data evaluation, all while adhering to CDISC/CDASH standards. Pentara's meticulous approach and use of industry-leading technology guarantee clean, reliable data from eCRF design to database lock and final study archival. This expertise also makes us your idea partner for data and CRO monitoring.
Data Management ServicesBiostatistics
Pentara provides automated, compliant, and high-quality tables, listings, and figures for regulatory submissions, offering specialized and novel analyses across all research phases. Our TLF templates have been accepted in NDAs, and we specialize in optimizing efficacy outcome analyses using historical data, simulations, and literature reviews. Our expertise includes MMRM, Cox proportional hazards, nonparametric, and multivariate analyses.
Biostatistics ServicesStatistical Consulting
Pentara specializes in providing statistical and strategic advice for clinical trials, particularly for neurodegenerative diseases. Our services include conducting literature reviews and developing superior study designs by determining optimal outcomes, sample sizes, and overall study strategies. Additionally, Pentara offers a unique, integrated statistical perspective throughout the clinical trial lifecycle, from data collection to final reporting, and provides independent statistical second opinions for strategic decision-making.
Statistical Consulting ServicesMedical Writing
Pentara provides a range of medical writing services, including SAPs, CSRs, literature reviews, and publications, with customizable depth and timing to fit client budgets and goals. We collaborate with client teams, offering support from initial frameworks to final reviews and journal submissions. We employ experienced staff to deliver statistical reviews, comprehensive reviews, and properly formatted documents.
Medical Writing ServicesRegulatory Support
Pentara supports clients through the drug development regulatory process by preparing them for interactions with authorities like the FDA and EMA. This includes preparing briefing documents, writing questions, and providing support during meetings. Pentara also guides clients on regulatory requirements, ensuring compliance and minimizing risks.
Regulatory Support Services