At Stark Pharma, we transform complex clinical data into actionable insights and regulatory-compliant outputs through robust biostatistical support. Our experienced statisticians work across the product lifecycle—from protocol design to final study reports—ensuring your clinical trials generate accurate, valid, and submission-ready results.
We collaborate closely with clinical and regulatory teams to develop sound statistical methodologies, define endpoints, and ensure your trial design is scientifically rigorous and regulatory-compliant.
Our statisticians use validated software to determine optimal sample sizes and create randomization schedules that minimize bias and support reproducibility.
We perform descriptive, inferential, and advanced statistical analyses using SAS and R. Our services include interim looks, endpoint analysis, survival analysis, and subgroup evaluations to support DSMB reviews and regulatory decisions.
Stark Pharma provides Data Safety Monitoring Board (DSMB) support including data blinding/unblinding, interim reports, and statistical advice for ongoing risk-benefit evaluation.
We prepare statistically accurate tables, listings, and figures (TLFs) for inclusion in CSRs, ensuring clarity and precision in reporting outcomes to health authorities.
Our team supports a wide range of indications—oncology, immunology, cardiovascular, rare diseases, and more—with strong experience in both early-phase and late-stage trials.
We ensure your statistical outputs meet ICH E9, CDISC, and FDA/EMA submission standards—reducing delays and rework in your submission timelines.
We work hand-in-hand with data managers, medical writers, and regulatory teams to ensure seamless communication and consistent data interpretation.
+1 (732)760-5152
hr@starkpharma.com
