Clinical Strategy and Trials
Our clinical research consultants provide knowledge and experience from decades of planning, design, and interpreting results of clinical trials of medical device, drug and biologic products, as well as research studies evaluating in vitro diagnostics and drug/device combination products.
- Optimal strategies for all stages of clinical research, focused on product and therapeutic area requirements
- Clinical trial designs and protocols based on proven platforms
- Innovative approaches, including adaptive trial designs
- Medical writing services that expertly present the results of clinical testing
- Preparation of reports and submissions that are regulatory focused
RCCG experts include internationally recognized biostatisticians who have assisted clients to achieve more than 50 product approvals over the past 30 years.
- Proposed clinical trial designs to achieve study objectives
- Adaptive, Bayesian, and frequentist designs with well-timed interim analyses and Type I error control to meet trial objectives
- Endpoints inclusive of accepted efficacy and safety endpoints, composite endpoints, and innovative endpoints best suited to the intended use claim
- Comprehensive statistical sections of study protocols to define study hypotheses, analysis strategies, corresponding endpoints, interim analyses timing and alpha spending, and extending efficacy labeling claims through hierarchical testing.
- Prospective Statistical Analysis Plans (SAP) to robustly represent study objectives, labeling claims, and reimbursement
- Execution of SAPs in accordance with current GCP and ICH requirements
- Defenses of study designs at planning meetings, of analyses at 100-day meetings, and of product approvals at advisory panel meetings
- Statistical support to regulatory filings for market approvals, post-market obligations, health economics and outcomes research, clinical publications and other marketing needs