Innovative Analytics-CRO-Clinical Research Organization
Experience, Customer Focus, Quality

Clinical Biostatistics

Regulatory experience including NDA submissions, PMA Submissions, 510 (k) Clearances, ISS & ISE and litigation support in many therapeutic areas

To our team at Innovative Analytics:
Please find below a link to our website announcing the approval of ….! (We) would not have achieved this without your dedication and partnership throughout the past year! Once again, thank you for your assistance on the program and we look forward to future partnerships!
— Director, Clinical Program Management, small pharmaceutical company


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.



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.

Learn more about the IA Team.

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

  • Conduct meta-analyses

  • 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)

  • Study remediation 


we encourage you to Contact Innovative Analytics to request further information about how our Clinical statistics services can work for you.