BIOSTATISTICS CONSULTING SERVICES
The way your team plans, collects, manages, controls, analyzes, interprets and prepares clinical data can significantly impact the success of your trial. We bring 40 years of experience that will help deliver objective perspective to clients. We offer statistical consultancy in areas such as Protocol design & review, sample size calculations, statistical methodologies, Bayesian analysis, data quality oversight, development of protocols and Statistical Analysis Plans (SAPs), among other areas.
STATISTICAL ANALYSIS & PROGRAMMING
Members of our statistician team are accredited Professional Statisticians through the Statistical Society of Canada (SSC) and the American Statistical Association (ASA). We support a variety of technology solutions to efficiently collect, summarize and deliver data to members of project teams. Our statisticians ensure your objectives are clearly articulated in the protocol and supported by an efficient design, appropriately captured data, and pre-specified analyses.
CLINICAL TRIAL DESIGN SERVICES
Clinical trial design is a critical step in implementing a successful clinical research program. Our 40 years of experience will provide you with a tailored clinical trial design specific to your research goals. We can recommend appropriate trial designs ranging from simple single end point designs to more sophisticated Bayesian adaptive designs. We’ll develop clinical study plans and protocols and provide the knowledge and support that is required to best address your specific business goals.
CLINICAL DATA MANAGEMENT
We provide dedicated clinical data management services from database build to database lock and archiving. Our team is committed to customizing data solutions that emphasize cost efficiency, data integrity and accuracy. We excel at both paper-based formats and Electronic Data Capture (EDC). Our team of Clinical Data Managers are certified by the Society for Clinical Data Management (SCDM) and supported by compliance-driven Standard Operating Procedures.
REAL WORLD EVIDENCE SERVICES
The relatively new practice of Real World Evidence has proven to greatly enhance the quality and effectiveness of clinical studies. Developing evidence from real word data follows the same process as developing evidence from clinical trial data. Both RWE and Clinical Trials require careful planning and proper execution. Our team will work to understand the objectives of your research, explain what is required for your study and discuss recommended options with all necessary stakeholders.
STATISTICAL RESEARCH TRAINING
We produce custom training courses on Statistics for Clinical Research Professionals. This course covers protocol development, overall design concepts, analysis planning, data requirements, designing the study, interpreting results and statistical methods, among other topics. The primary focus is to provide an understanding of the key statistical components required and for individuals to be able to demonstrate competencies in these components and apply them to clinical trials.