Comprehensive Biostats Services Deliver Strategic, Timely & Customized Data Planning & Analysis for Your Needs
High quality and accurate data analysis is an important component of all clinical trials. Typically, it is thought by sponsors to occur at the end of a study when the CRO starts reporting results to sponsors and investors. However, Biostats can and should also function as an aspect that has value at the outset of the study and at multiple points throughout the clinical development process.
Experience matters. SynteractHCR was founded as a Biostats provider and has more than two decades of experience in this area. This longstanding Biostats expertise is now being offered to our clients in three different options depending on your needs:
- As part of a full service clinical research project
- As a consulting service from our expert Ph.Ds. to develop strategies that will improve your processes and oversight functions
- As a standalone project for those clients who are handling other aspects of trials in-house
Working as your partner, SynteractHCR’s expert biostatisticians and consulting group will review your study’s needs and determine the best methods for collecting, analyzing and presenting your data, all in compliance with regulatory guidelines. Our long-tenured team provides creative thinking and analysis optimized for your unique
SynteractHCR Biostatistics Experience is Comprehensive and Knowledgeable
You may choose any or all of these processes as part of your full-service, consulting or standalone Biostatistics options:
- Overall strategy, including: study design; randomization planning; establishment of priorities; sample size determination; selection of end points for EMA and FDA; determination of most appropriate analysis methods; ADaM; statistical analysis
- Regulatory strategy for Biostats: identification of documentation needed; guidance for FDA interaction, especially for end of Phase II and pre-NDA meetings; preparation and presentation of documents; briefing book; questions to anticipate
- Adaptive design and group sequential strategies: advantages and disadvantages for your individual study
- Innovative analyses and how to implement - e.g., Lag-time analysis was developed by our Senior Principal Biostatistician Ed Lakatos
- Integration of CDISC into entire study: review of legacy data and how to convert legacy studies to full CDISC compliant databases to meet requirements deadlines
- Timeline planning: requirements for each step prior to submission
- Safety monitoring: reviewing safety data throughout the course of the study; establishment and coordination of data monitoring committees; participating on your DSM board or data monitoring committee
- Consulting on ISS/ISE: identification of data to pull together from different studies; how to propose analyses from integrated designs
- Statistical reports and/or review of your clinical reports
- Collaboration with your Regulatory Group: cross-functional strategy and design of studies so they are acceptable to both EMA and FDA
Since its inception, SynteractHCR has contributed to marketing applications and regulatory submissions. Our processes and experience have evolved and adapted quickly with the rapidly changing regulation landscape. We provide access to your data in a format well-suited to your project requirements (21 CFR Part 11, eCTD, CDISC) and that meets regulatory standards.
SynteractHCR is able to provide “out of the box” thinking and analysis that will improve your clinical study design and biostats output with a responsiveness that is unmatched in the industry. Work with SynteractHCR to ensure the best statistical services for your trials.