What we do

BioTrak specializes in custom consulting services for Risk Evaluation and Mitigation Strategy (REMS) program design and assessment, comprehension studies for medical education materials and labeling, usability studies for medical products, and other observational research study initiatives.

Experts at your service

Our client services are lead by an area expert who not only oversees the research process, but is directly responsible for the conduct of the research and subsequent analysis and report writing. We believe this personal touch approach is fundamentally different than what a client might have experienced with large contract research organization.

Our Pharmaceutical Risk Management research services specifically offer unique expertise and solutions for drug safety programs, e.g.:

  • Development and implementation of Risk Evaluation and Mitigation Strategies (REMS) programs, including those with Elements to Assure Safe Use (ETASU). When the industry was looking for a solution, we established a best practices approach to conducting REMS assessments that are high quality, reliable and predictably measure program effectiveness.
  • Application of risk modeling assessment tools, including use of simulation software programs like @RISK, PrecisionTree, and RISKview. These tools are often applied to creating models that predict the best probable outcomes among a range of risk management options.
  • Advanced analytics and statistical support.

Learn more:

REMS Assessments
REMS Consulting Services
ETASU Programs
Recent Examples

Our Human Factors research services include labeling comprehension studies, usability studies, and human factors engineering studies.

Learn more:

Labeling Comprehension Studies
Usability Studies
Recent Examples
Case Studies

Larry A. Risen
Larry A. RisenPresident and CEO
Mr. Risen founded BioTrak in 1999. Prior to BioTrak, Mr. Risen was Vice President of Commercial Development at Cypros Pharmaceutical Corporation (now Questcor) from 1994 to 1999, where he built a sales and marketing organization, coordinated development of a new drug distribution facility, and completed several product licensing deals. Prior to Cypros, Mr. Risen held various management level positions in marketing and product development while at Gen-Probe Inc. and Molecular Biosystems Inc. Mr. Risen received his Bachelor of Science degree in Biology from the University of Iowa and completed his MBA studies at the University of San Diego. He has been a featured speaker at national and regional industry conferences and has authored several articles and videos on REMS assessment, REMS program design, and labeling comprehension studies.
  • 30 years of medical industry commercial experience
  • Project leader/director on over 250 consulting assignments involving REMS, Risk Management Plans and drug safety programs, human factors research, labeling comprehension, product planning, commercial strategy, and commercial support services. This included over 40 REMS programs, over 200 web-hosted patient and prescriber surveys, and a broad range of drug safety and commercial research.
  • Managed 20 new product launches – 3 Rx, 17 Dx
  • Built 2 specialty pharma commercial programs from ground up
  • Designed novel, reliable and predicable methods for REMS assessments
Gerard Smits, PhD
Gerard Smits, PhDSenior Consultant Biostatistics and Data Management
Dr. Smits brings over 30 years of biostatistical experience with pharmaceutical, device, and biotech companies, working for 25 years as an independent consultant. He provided statistical support on pre-clinical through phase IV studies on a wide variety of indications (e.g., oncology, renal disease, anemia, heart failure, myocardial infarction, hepatitis B and C, hypertension, insomnia, vision correction, robotic surgical intervention, surgical treatment of obesity, and CNS trauma). His responsibilities have ranged from study design and formulation through statistical analysis, table production, writing of statistical reports, meetings with the FDA as needed, including panel meetings, and have served as a DSMB member. Dr. Smits has managed clinical trials, survey research, and human factors projects. Taught several courses SAS, having 28 years experience with the statistical package. Dr. Smits is proficient with StatXact (exact statistical tests), and PEST (group sequential methods), and R (a general data analysis program) and able to explain complex statistical concepts in terms understandable to non-statisticians.
Elaine WeltySenior Project Manager and Quality Assurance Lead
Over twenty years experience in all levels and facets of business operations, with a concentration in project management, sales, and executive administration. Developed skills such as strong leadership, problem solving and strong interpersonal communication, written as well as verbal. Major strength in deadline oriented projects, ensuring projects are well organized and executed partnered with a passion for exemplary relational interactions with all levels of co-workers and clients.

Seven years direct experience in project management of all aspects of REMS assessment programs, human factors research, and labeling comprehension studies, including;

  • Protocol and survey development
  • Survey design, programming, QC and validation, web hosting
  • HCP and patient recruitment using varied recruitment methodologies
  • Management of HCP and patient call-center
  • Management of all REMS materials per Quality Program guidelines
  • Assist in REMS assessment report development, data collection and reporting