How we do clinical statistics at Innovative Analytics
IA PhD statisticians provide a source of expert knowledge on scientific, regulatory, and industry requirements for clinical studies. With regulatory experience including NDA submissions, Premarket Approval (PMA) Submissions, 510 (k) Clearances, Integrated Summaries of Safety and Efficacy (ISS & ISE) and litigation support, and experience in many therapeutic areas, IA offers insight and perspective that contribute significantly to your clinical program. IA has assisted clients with adaptive trial designs, including continual reassessment method, biomarker-based treatment allocation and patient selection, group sequential designs, seamless phase II/III designs, single protocol SAD/MAD designs, sample size re-estimation, futility and superiority stopping rules.
This level of experience allows IA to help our clients with innovative planning and study design and superior execution, resulting in decreased clinical trial costs and time and the increased probability of trial success.
At IA, our statisticians strive to become an integral part of the project team and work with the sponsor’s goals and interests in mind. Our statisticians demonstrate an intense attention to detail regarding scientific content, regulatory guidelines, and data standards (CDISC). The IA statistician will stay with your project from beginning to end, and we have the practical experience to provide your team with effective, high-quality analysis from early development to regulatory submission and review.
INNOVATIVE ANALYTICS offers EFFECTIVE ANALYSIS and REGULATORY SUBMISSION EXPERIENCE
IA provided effective analysis through the integration of 6 oncology studies from 3 CROs to answer questions about hepatotoxicity.
Through participation in ISS, ISE, and pivotal study analysis, while incorporating industry best practice in a cost effective manner, IA offers significant experience in providing data and analysis for regulatory submissions.
IA’s goal is to become a part of the clinical team, working to ensure quality, timelines, and the ultimate successful end result.
Innovative Analytics offers the following Statistical Analysis Services:
Regulatory guidance meeting consulting
Statistical Analysis Plans and Interim Analysis Plans
Phase I – IV traditional primary safety/efficacy analyses
Innovative/adaptive statistical designs
Development and validation of biomarkers, novel endpoints
Receiver Operating Characteristic (ROC) analysis for diagnostics
Exploratory analyses – data mining, decision trees
Analyses of integrated study results
Statistical analyses for publications
Statistical sections of protocols and study reports
Data Safety Monitoring Board (DSMB) support
Product registration and defense activities
Integrated Summary of Safety (ISS)
Integrated summary of Efficacy (ISE)