Nth Analytics

A Technology-Leading CRO for 25+ Years

Founded in 1989, Nth Analytics is a CRO that employs a deliberately small team of SAS programmers and biostatisticians to handle mission-critical assignments with the precision expected by pharmaceutical and biotech organizations, and to work at the fore of technological advancements and requirements in the industry.

For inquiries, please contact info@nthanalytics.com.

Recent projects

In collaboration with Dr. Mary Johnson, MJ Biostat:

2018-19: Oncology studies; FDA submission deliverables using Pinnacle21 Enterprise, SAP; fully validated, standalone SDTM, ADaM, and TLG SAS programs suitable for regulatory submission; statistical analyses, tables, listings, and graphs.
2018-19: Oncology study; unblinded statisticians for Data Monitoring Committee (DMC). Statistical reports and follow-up analyses for DMC.
2017: COPD study; fully validated, automated patient safety narratives for serious adverse events, preserving medical writers' comments in subsequent iterations.

Further:

2017-18: Major Depressive Disorder study; statistical support for machine-learning analyses.

Key Associates

Mike Todd, President

Michael Todd has over 25 years of experience in SAS programming, and has been involved in technology-mandated projects such as Pinnacle21 Enterprise for CDISC-compliant FDA submissions, as well as having been an invited speaker at 3 CDISC Interchange conferences as a recognized CDISC expert.

Anne Russotto, Consultant

Anne Russotto manages all project team activities at Nth Analytics, with extensive experience determining business requirements for all stages of clinical trials. She is also a CDISC SDTM expert with over 15 years of experience in management of CDISC implementation, as well as major contributions to the CDISC SDS team.

Wenjiong Zhou, Consultant

With over 20 years of experience in the pharmaceutical and CRO industry, Dr. Wenjiong Zhou has worked with Nth Analytics for the past 6 years as a senior biostatistician preparing statistical analysis plans and responsible for the review and validation of project TLFs for the company.

Recent Publications and Presentations

Publications:

"Characterization of Atrial Fibrillation Adverse Events Reported in Ibrutinib Randomized Controlled Registration Trials"

Haematologica. 2017; 102(10): 1796-1805.

"Efficacy and Safety of Carisbamate in Patients with Diabetic Neuropathy or Postherpetic Neuralgia"

Pain Practice. 2013; 14(4): 332-342.

"Adaptive Behavior Outcomes in Infants Treated With Adjunctive Topiramate"

Pediatric Neurology. 2012; 46(6): 350-358.

"Long-Term Open-Label Study of Adjunctive Topiramate in Infants With Refractory Partial-Onset Seizures"

J Child Neurol. 2011; 26(10): 1271-83.

Presentations:

"Self-reported Burden of Illness in Patients with...Depressive Disorder..."

American College of Neuropsychopharmacology, 28 November 2018.

"Pooled Analysis of Atrial Fibrillation Adverse Events in Ibrutinib..."

American Society of Hematology, 3 December 2016.

"Using Google to Solve SAS Programming Problems"

SAPA Clinical Programming Workshop, 10 October 2009.