Vita Data Sciences has developed a network of statisticians who are at the cutting-edge of advance statistical design and analysis, with in-depth expertise across therapeutic areas. Irrespective of where you are in the product development lifecycle and approval process, Vita Data Sciences can provide you with the strategic consulting needed in performing/optimizing the trial design and developing a statistical analysis plan which will detail the safety and efficacy analysis methods required for securing marketing approval. We also have ample experience in representing the customer at regulatory body meetings. Our Biostatistics team offers services on complex statistical issues encountered during study design or analysis. They bring expertise and insights in trial design, sample size calculations, randomization, interim analyses, developing complex statistical analysis plans (SAPs), and consulting on adaptive design. They have extensive experience in interacting with FDA and are actively collaborating with academia, industry and FDA working groups.

Vita Data Sciences has expert SAS® programmers who tactfully and efficiently handle clinical trial data to provide outputs in accordance with industry and regulatory standards. Our team quickly adapts client specific technologies and best practices and provides insightful analysis and clinical study reports that empowers clients to draw interpretations and make well-informed decisions. A clearly laid out QC procedure helps us to deliver results on time, and with utmost quality.

Our data scientist team is highly skilled and experienced in assisting clients with clinical data standardization across all therapeutic areas in compliance with CDISC standards. They are actively involved in PhUSE industry working groups, contributing towards shaping the future of data standards. You can be hence assured that Vita Data Sciences offers up-to-date intelligence and solutions to clients looking to develop “submission-ready datasets”. Our CDISC implementations enhances efficient data analysis and reporting, including regulatory review.

Our Statistical Programming and Data Submission team is well versed in CDISC standards and have in-depth knowledge and experience in producing FDA compliant datasets and TLFs towards submission. We take an active role in CDISC initiatives to help the industry simplify and standardize data mapping, review and submission process. As such, our team has supported multiple sponsor companies to establish CDISC, SDTM and ADaM standards at a program and therapeutic area level. We have been involved with multiple successful NDA submissions to the FDA and have built solid expertise in ensuring all the clinical data deliverables from VDS are ‘submission-ready’.

Pharmacometrics is a relatively new area of clinical research that aggregates drug, disease, patient and trial information, analyzes them and build models that will augment optimized drug development and/or regulatory agency decisions. Drug models describe the relationship between exposure (or pharmacokinetics), response (or pharmacodynamics) for both desired and undesired effects, and individual patient characteristics. Vita Data Sciences offers expert consulting and services in quantitative pharmacometrics. Our clients can benefit from our team’s proficiency in the following: