About BioStat Solutions, Inc.
BioStat Solutions, Inc. is a leading provider of biostatistics and statistical programming services to the pharmaceutical, biotechnology, medical device, and healthcare industries. The company has been in operation for over 20 years and has established itself as a trusted partner for clients seeking high-quality statistical support throughout the drug development process.
At BioStat Solutions, we understand that every drug development program is unique and requires a tailored approach to meet specific needs. Our team of experienced statisticians works closely with clients to provide customized solutions that address their specific challenges. We guide our clients from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes, and post-approval/maintenance post-launch activities.
Our services include statistical consulting, study design and protocol development, sample size calculations, randomization schedules generation (including adaptive designs), data management (including EDC), statistical analysis plan preparation (SAP), interim/final analyses (including Bayesian methods), data monitoring committee support (DMC/DSMB) , regulatory submissions support including FDA meetings preparation , NDA/BLA/PMA submissions , post-marketing surveillance studies design & analysis , real-world evidence generation & analysis.
We have extensive experience working with all phases of clinical trials across multiple therapeutic areas including oncology/hematology; cardiovascular/metabolic diseases; infectious diseases/vaccines; neurology/psychiatry; respiratory/allergy/inflammation ; rare diseases/orphan drugs ; medical devices/diagnostics/biosimilars . Our team members have advanced degrees in statistics or related fields such as mathematics or computer science from top universities around the world.
At BioStat Solutions we pride ourselves on our ability to deliver high-quality work on time while maintaining excellent communication with our clients throughout the project lifecycle. We use state-of-the-art software tools such as SAS®, R®, nQuery® Advisor for sample size calculation & Power Analysis , EAST® for adaptive designs simulation & implementation . We also follow industry standards such as CDISC SDTM/ADaM models for data standardization .
Our commitment to quality is reflected in our ISO 9001:2015 certification which ensures that we adhere to strict quality management principles in all aspects of our operations. Additionally we are compliant with GDPR regulations regarding privacy protection .
In conclusion BioStat Solutions offers comprehensive biostatistics services designed to help you achieve your goals efficiently while ensuring compliance with regulatory requirements . Contact us today to learn more about how we can help you succeed!