Chastain Research Group, Inc.

Chastain Research Group, Inc. (ChRG) specializes in statistical analysis, statistical programming (primarily SAS®) and data management for Clinical Trial Research (IND, Phases I–IV, NDA, BLA, PMA, DMC/DCC, post-marketing) through its founder Dr. Robert "Bob" Chastain supporting Pharmaceutical, Biotechnology and Medical Device submissons.

Dr. Bob Chastain has over 25 years of clinical trials research experience (i.e., Phase I-Phase IV, NDA, BLA, Integrated Summaries of Safety (ISS), Integrated Summaries of Efficacy (ISE), toxicology, bioequivalence, quality assurance, pharmacokinetic (PK), pharmacodynamic (PD), pharmacoeconomic (PE), Quality of Life (QOL), Patient Reported Outcomes (PRO), etc.) including statistical analysis, protocol writing (including drug development study design, sample size & power calculations), statistical analysis plan (SAP) writing/development (including mockups for tables, listings and figures), clinical study report (CSR) writing, data monitoring committee (DMC) charters and work, CRO selection & management, data management plans, and computer programming support in many therapeutic areas including oncology, cardiovascular, allergy, immunology, ophthalmology, dermatology, transplant, pain, quality of life, etc.

Dr. Bob took his first biostatistics course on censored data in 1983 at Texas A&M University by Laurel Beckett, currently Professor, Biostatistics Division Chief, Vice Chair Department of Public Health Sciences, School of Medicine at University of California, Davis. First hired as a biostatistician in 1985 by the late Byron William “Bill” Brown, former Biostatistics Division Chief, Department of Health Research & Policy, School of Medicine at Stanford University.

American Statistical Association (ASA) member since 1984 (Life Member); SAS® programmer since 1982; SAS® Certified Professional V6 (1999); SAS® Certified Professional V9 (2007). Expert in SAS® Macro, SQL, Graph and SAS® programming validation. Regulatory Affairs Certified (RAPS) 1999-2001; licensed attorney-at-law. Submission experience with NDAs, BLAs and PMEs including many pivotal clinical trials: Amphocil/Amphotec (liposomal amphotericin B for fungal invasions), Avastin (bevacizumab for colorectal, lung & breast cancer), Cardene (nicardipine HCL, immediate and sustained release for angina), Cytovene (ganciclovir for CMV retinitis), Doxil (liposomal doxorubicin for Kaposi’s sarcoma), Enprostil for peptic ulcers, Integrilin (eptifibatide for acute coronary syndrome), Prograf (tacrolimus for transplant rejection), Ranolazine SR for angina, Raptiva (efalizumab for psoriasis), Synarel (nafarelin acetate for precocious puberty), Ticlid (ticlopidine HCL for cerebrovascular, coronary artery and peripheral vascular diseases), Toradol (ketorolac tromethamine, an ophthalmic NSAID for ocular pain), Vibriolysin (a proteolytic enzyme for burns) and Xolair (omalizumab for asthma).