Clinical Development

Boost clinical development with years of detailed data addressing all aspects of trial management.

Pharmacovigilance (PH225)

Balance pharmacovigilance resources and structures, coordinate case management and other drug safety activities and adjust standard operating practices to better align with new regulatory guidance.

Trial Master File Management (PH215)

Use trial master file management to ensure timely document submissions and to implement e-filing systems to better prepare for regulatory audits and inspections.

Clinical Outsourcing (PH209)

Use clinical outsourcing benchmarks and best practices to improve clinical structures, vendor and site selection and management, and patient recruitment.

Risk-Based Monitoring (PH205)

Simplify risk-based monitoring and use it to facilitate trial processes and anticipate issues related to RBM implementation.

Clinical Investigator FMV and Compensation Benchmarks (PH202)

Our new clinical investigator FMV study focuses on promoting transparency by building accurate calculation procedures, establishing investigator payment schedules to keep trials on track and organizing successful investigator meetings while staying within a budget.  The report also includes key performance indicators, such as pass-through/direct cost benchmarks, average investigator compensation across nine therapeutic areas, annual compensation limits for principal investigators, and cost-per-attendee metrics for investigator meetings.

Clinical Development and Trial Operations (PH192)

This report provides a benchmarking tool to use cost-per-patient metrics to guide budgeting decisions, set clinical trial headcounts appropriately and set outsourcing strategy with trial data from 22 different therapeutic areas.

Oncology Clinical Trials (PH180)

Benchmark oncology clinical trials’ key metrics, including duration, staffing, budgets and cost-drivers’ impacts.

Phase I Clinical Trials (PH173)

Manage critical Phase I clinical trial cost drivers and prevent expensive delays to move projects through early-stage development.

Companion Diagnostics and Biomarker Development (PH169)

Harness companion diagnostic metrics to set strategy, improve partner selection and build a program of targeted therapy development. Ratings and benchmarks explore resource levels and therapeutic area details.

Emerging Markets Clinical Trials: Africa (PH147)

Explore the next frontier of emerging markets to build a clinical foundation that generates decades of benefits for developers and patients.

Emerging Markets Clinical Trials: Latin America (PH146)

Boost trials with Latin America’s untapped clinical promise, including patient availability, established infrastructure, and convenient communication.

Emerging Markets Clinical Trials: Eastern Europe (PH145)

Make sense of Europe’s emerging markets to accelerate clinical development and save money while addressing region-specific challenges.

Emerging Markets Clinical Trials: Asia (PH144)

Navigate the maze of emerging Asian markets to improve patient access and retention while sidestepping clinical teams' common mistakes.

Emerging Markets Clinical Trials: BRIC Countries (PH143)

Confidently tap BRIC's potential to deliver patients and lower costs while avoiding the pitfalls common to these new markets.

Clinical Trial Patient Recruitment (PH140)

Chart a comprehensive recruiting and retention strategy with specific tools, processes and resource benchmarks.