Services & Solutions
End-to-End Peri- and Post-Approval Clinical Research Solutions
Understandably, the main focus of companies developing medical technology is getting that technology to market as rapidly as possible. As a result, peri- and post-approval data generation and clinical study planning are often deprioritized and not integrated into standard launch workflows.
Traditional large CROs focus heavily on early- to late-phase registration trials, similarly deprioritizing post-approval clinical research services as a core offering. At Renaissance Associates, we focus solely on the complexities, nuances, and unique challenges of peri- and post-approval data generation. We help our clients differentiate products, expand or refine labels, protect market share, and satisfy regulatory mandates.
Service Offerings
Peri- and Post-Approval Strategic Guidance
Strategic Alignment & Lifecycle Optimization: We bridge the gap between scientific and commercial objectives by aligning cross-functional stakeholders - including Clinical Research, Medical Affairs, Product Brand Management, and Regulatory Affairs. We help companies design peri- and post-approval data generation programs that systematically unlock commercial value, optimize product labels, and successfully satisfy global regulatory obligations.
Peri- and Post-Approval Study Conduct (Core Offering)
Comprehensive Trial Execution & Operational Rigor: Full-service clinical operations capabilities covering, but not limited to, medical writing [protocol, ICF, all Plans (e.g., DMP, SAP, etc.), and CSR], study supplies (Investigational Product, study binders), recruitment (study website development, patient vetting), IRB management, ClinicalTrials.gov registration, site/study start-up, project management, virtual and on-site monitoring, data management (including EDC system programming and UAT), and biostatistical analysis (TLF development).
Specialized Post-Marketing Clinical Study Frameworks:
Corporate-Sponsored Trials (CST)
Peri- and post-approval studies managed to the absolute operational rigor of registration trials to support regulatory body mandates and label enhancement.
Investigator-Sponsored Trials (IST)
Tailored oversight built for the unique nature of investigator-led studies. We provide critical milestone verification and investigator support to guarantee high data quality, protect timelines, and maximize ROI.
Observational Registries
Programs configured to assess real-world, long-term safety and efficacy profiles across highly complex, diverse patient cohorts post-launch.
Head-to-Head Comparative Studies
Robust clinical evidence generation configured to systematically exploit competitor product vulnerabilities, unwanted safety signals, or delivery gaps.
Health Economics & Outcomes Research (HEOR)
Scientific studies designed to demonstrate clear pharmacoeconomic and/or quality-of-life (QoL) value to satisfy global payers.
Data Dissemination Services
Scientific Communications Continuity: A post-approval study is only successful when its evidence is effectively communicated to the marketplace. To prevent downstream translation delays and preserve scientific continuity, our medical writing team is involved from protocol inception. As a result, we seamlessly translate study results into high-impact communication vehicles, including peer-reviewed manuscripts, abstracts, scientific posters, platform presentations, white papers, and comprehensive internal literature reviews.