Your strategic partner for study design, statistical analysis, and reporting of results from nonclinical and clinical research studies.
CLARITY • INTEGRITY • EXPERIENCE
CLINICAL TRIAL DESIGN
Accudata Solutions has over 25 years of experience helping pharmaceutical, medical device, diagnostic, and biotech companies design better studies with a unique combination of intentional, jargon-free communication with all clinical team members and cutting-edge statistical methodology.
Sample Size Estimation
Selection of endpoints including multiple primary endpoints, hierarchical endpoints, composite endpoints
Advanced study design, e.g. group sequential, adaptive
Negotiation with IRBs and regulatory bodies
Regulatory pathways: 510(k), De Novo, LDT, PMA, NDA, BLA
BIOSTATISTICAL ANALYSIS OF
With the implementation of revised GCPs (ICH E6 Rev 2), scientific integrity of research results requires a holistic approach to data quality now more than ever. The timing, scrutiny, and thoroughness of data recording have to be congruent with the importance of those data to the overall product story. Accudata Solutions uses a comprehensive and integrated approach to data capture, analysis, presentation, and interpretation.
Generation of randomization schemes
Edit checks, consistency checks, logic checks, data reconciliation
Production of Tables, Listings, and Figures for Clinical Study Report
Management/oversight/QC of CRO activities
PRE-CLINICAL / NON-CLINICAL STATISTICS
Optimal research design can involve complicated statistical considerations. Even when guidances are available, they are often vague or not applicable to a Sponsor’s particular experimental situation. By focusing on the objective of meeting, or exceeding, the acceptance criterion, Accudata Solutions helps Sponsors choose an experimental design and analysis strategy that is proportional to the requirement.
Experimental design and analysis of:
Assay Development and Validation studies
Methods Transfer/Equivalence/Comparability studies
MEDICAL DEVICE AND
Increasingly, even devices and diagnostics following 510(k) approval are requiring clinical data. Optimal research design can involve complicated statistical considerations and limited availability of samples. Even when guidances are available, they are often vague or not applicable to a Sponsor’s particular experimental situation. By focusing on choosing an acceptance criterion that is proportional to the regulatory requirement, Accudata Solutions helps Sponsors choose the right experimental design and analysis strategy.
Statistical design and analysis of:
Design Verification and Validation studies
Diagnostic Performance studies(accuracy, precision, agreement, PPV, NPV, concordance, ROC)
Calibration to Reference Standards (WHO-IS, NIBSC)
Methods comparison studies(e.g. CLSI)
"In all aspects of the project and interpersonal interaction, Doug was outstanding, adding value as an active participant and advisor to the cross-functional clinical study teams. Doug demonstrated the breadth of his statistical knowledge and flexible approach in writing statistical analysis plans for these studies, both of which incorporated novel design elements. Doug was genuinely interested in fully understanding the clinical and scientific goals and methods of the studies and it was precisely because of this that he was able to offer significant, nuanced, and on-target advice as to handling of data, analyses, approaches to randomization, and interpretation of findings during the life of the projects. Doug was a fantastic asset and resource."
Clinical Drug Development Consultant
Vandana Mathur M.D. , FASN
"It is difficult to choose THREE attributes that best describe my experience in working with Doug because ALL of the defined attributes apply to this fine man; personally and professionally. Doug has provided valuable assistance in evaluating the clinical databases and writing the biostatistical section for a multicenter FDA IDE clinical trial. I look forward to working with Doug in the near future on another clinical study evaluation.I highly recommend Doug as a biostatistician who is an expert in his field; providing great results of the highest integrity, on time, while being creative when appropriate and providing a good value for his services. Additionally, Doug is a very personable individual."
Russ D. Hibbert
Director of Clinical and Regulatory Affairs,
Curexo Technologies/ Integrated Surgical Systems
"I worked with Doug extensively on multiple clinical trials for different medical device companies. He is an experienced statistician with a commitment to scientific integrity. He is able to easily translate statistical analyses for clinical applications."
Chief Medical Officer
Kathy Stecco M.D. CEO and Co-founder of Panther Orthopedics
"Doug demonstrated a good grasp of [the]complexity of our GMP analytical methods and was able to apply a variety of statistical analysis methods to help us get the most value from our existing data."
Manager of Assay Development
Applied Immune Sciences
"It’s my pleasure to strongly recommend Doug Milikien for his capability, responsiveness and effectiveness. Doug provided expert analytical support for the Novate SENTRY Trial that was pivotal to the FDA’s approval of the Sentry IVC Filter. He worked effectively with aggressive timelines, delivering quality, accurate tables, listings and analyses on or ahead of schedule. I’ve also collaborated with Doug on protocol development in a novel therapeutic area that required research of new clinical endpoints, and appropriate sample size determination, that was clinically and statistically meaningful. Doug is a clear thinker and calm presence."
Dennis McHugh, Clinical Development Professional
(previously Novate Medical Ltd.)
"I worked with Doug on a very complicated study which was underway at the time he joined Jazz as a consultant. I was impressed by his ability to quickly come up to speed on both the study protocol as well as the therapeutic area. Doug demonstrated a high level of thoroughness and detail in evaluating data (leaving no stone unturned) and applied strong technical and analytical skills to consistently deliver quality analyses in a timely manner. In addition, he communicated key ideas, conclusions, and recommendations succinctly and effectively in one-on-one or small-group settings, and written communications. I would highly recommend Doug and would enjoy the opportunity to work with him again."
I-Zu Huang M.D.
Executive Director, Medical Affairs
"Doug was hired to do a job that required exceptional creativity and attention to detail as well as adherence to tight timelines. He exceeded our high expectations. He delivered outstanding and thoughtfully crafted work product on time with the highest of integrity. Excellent in all respects."
Bruce Scharschmidt M.D.
SVP and Chief Medical Officer
"Doug is able to communicate well with members of the clinical group, as well as personnel from regulatory and preclinical. In helping us make the most of the data, he has a real knack for asking the right kind of questions to elicit what we want to learn from a study, and translating that into logical and defensible analyses.
Marvin R. Garovoy, M.D.
Vice President, Clinical and Medical Affairs
ABOUT ACCUDATA SOLUTIONS
FOUNDER & PRINCIPAL CONSULTING STATISTICIAN DOUG MILIKIEN
Accudata Solutions specializes in working with small- to medium-sized pharmaceutical, medical device, and biotechnology companies who need timely, to-the-point advice on study design, data management, data analysis, and quality control methods.
Our flexible and personal approach to client relationships fosters continuity and encourages easy dialogue free of statistical jargon. Doug has developed a unique strategic partnership approach that can help you assess your needs and make sure you’ve considered the most important options and targeted the best means to go about it. By knowing the end requirements, he can assist you down the most effective and strategic path toward approval. The result is a more rational scientific approach and a better understanding of its quantitative implications.
Doug received his Master’s Degree in Biostatistics, Master’s Degree in Demography, and Bachelor’s Degree in Statistics—all from the University of California, Berkeley. Involved in pharmaceutical, medical device, and diagnostics for over 25 years, Doug began his postgraduate career as a Research Statistician with the Northern California Alzheimer’s Disease Center. After two years working for a statistical consulting firm, Doug founded Accudata Solutions in 1991. He has been involved in 10 regulatory submissions, including leadership roles in 4 PMA submissions, 1 NDA approval and 1 510(k) approval. Doug has served as a voting member of a Data Safety Monitoring Board and served as instructor to pharmaceutical scientists at the Institute for International Research as well as in-house instructor to Bayer Pharmaceutical-Biotechnology Division. He is the author of numerous peer-reviewed articles and presentations to the American Statistical Association, American Society for Quality, and Parenteral Drug Association.
In serving manufacturers of drugs, biologics, medical devices, diagnostics, and gene therapy companies, Doug has provided services in the following therapeutic areas:
Central Nervous System
RECENT ARTICLES BY PRINCIPAL CONSULTING STATISTICIAN DOUG MILIKIEN
ACCUDATA SOLUTIONS ARTICLES
The RegEx Trial: a Randomized, Double-blind, Placebo- and Active-Controlled Pilot Study
Maximizing the diagnostic utility of myocardial perfusion imaging is predicated on the ability to obtain the highest quality images. To this end, a number of testing strategies have been evaluated utilizing vasodilators as myocardial stress agents.
Blood Ammonia and Glutamine as Predictors of Hyperammonemic Crises in Patients with Urea Cycle Disorder
The aim of this study was to examine predictors of ammo- nia exposure and hyperammonemic crises in patients with urea cycle disorders.
SCHEDULE YOUR CONSULTATION
OUR PROCESS IS EASY:
We start with a simple needs assessment by asking, “When the research is complete, what compelling story do you wish to tell about your product?”
Using jargon-free language, we clearly explain the implications of your choices.
By offering boutique-style flexibility, we can solve a specific problem or fully integrate into your study team.
We offer methodologies that are not only on-target with your compelling story, but will withstand the scrutiny of regulatory bodies. By smoothing the review process, your organization is happier!