SAS Provides BioMimetic With Serious Analytics For Clinical Trials
BMTI develops bio-active recombinant protein-device combination products for healing musculoskeletal injuries and disease for a broad range of orthopedic clinical indications. Currently underway is a North American pivotal clinical study to assess the safety and efficacy of Augment™ Bone Graft, BioMimetic's lead orthopedic product candidate.
Before SAS, BMTI used contract research organizations (CROs) to run simple bio-assay analyses. Routine statistical calculations used unwieldy spreadsheet interfaces.
"We needed clinical trial reporting and repeatable, programmable statistical computations, from t-tests to Kolmogorov-Smirnov tests, from linear models to survival analysis and mixed models, and everything in between," said Rafe Donahue, PhD., Associate Director, Statistics at BioMimetic. "Using SAS we now see data from our clinical trials in formats other than spreadsheets. We can pinpoint issues as they manifest, and be more nimble."
Donahue predicts BMTI will save approximately $100,000 in 2009 by doing bio-assay analyses in-house using SAS Visual Data Discovery instead of outsourcing.
Weighing SAS against other options, Donahue found comfort in having one of the world's largest software companies standing behind their products.
"I have worked extensively with open source software, and it works very well in certain situations, but it also has drawbacks. In this highly regulated environment, SAS' commitment to developing high-quality, industrial strength analytics provides us with the confidence we need to be successful," said Donahue. "SAS' complete documentation and live technical support is priceless. The R&D, validation, and verification behind SAS give me great confidence in the computations I do with their applications. We were able to hit the ground running."
As BioMimetic grows so do its analytic needs
"Every week the statistics department gets new questions we can only answer via serious data analysis. SAS gives us that capacity and the support to make it work. As BioMimetic grows, we will continue to expand the statistics department and the ability to provide accurate, timely answers to any portion of the company that needs data," added Donahue. "SAS is an integral component of the analysis and delivery framework we are building."
SAS channel partner Pinnacle Solutions was instrumental in helping BioMimetic implement SAS. Pinnacle Solutions helped BioMimetic bridge the gap between existing SAS expertise on older tools with newer SAS technologies.
Pinnacle was a great asset during implementation," said Donahue. "The president of Pinnacle came on-site to walk us through SAS® Enterprise Guide and the overall installation. I appreciate the personal attention. Pinnacle's high customer service standards and knowledge of the technology helped me feel confident in our decision to implement SAS. I cannot say enough good things about Pinnacle."
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