Supporting your program from discovery through registration and
regulatory submission.
Services
Clinical Strategy, Planning & Operations
Phase 1 study planning and operations
Efficient dose escalation and dose ranging studies using
Bayesian based designs
End-of-Phase 1 and End-of-Phase 2 planning and regulatory
interactions
Clinical strategy for drug registration and regulatory
planning
Efficient and accelerated Phases 2 and 3 study designs and
development
Provide services in protocol and statistical analysis plan
development, clinical operations, data management,
biostatistics and statistical programming areas
Support regulatory interactions including regulatory agency
meeting strategies, briefing package development and responses
to questions from regulatory agencies
Clinical Data Management & Medical Review Services
End-to-end data management services including CRF design
review, database validation, data cleaning, query management,
database lock, and submission readiness.
Comprehensive medical review of patient profiles, adverse
events, laboratory data, concomitant medications, protocol
deviations, and safety data to identify discrepancies, trends,
and potential safety signals.
Accurate and consistent coding of adverse events, medical
history, and concomitant medications using MedDRA and WHO Drug
dictionaries.
Flexible resourcing and consulting across clinical data
management, medical review, coding, data standards, and
clinical programming to support sponsors and CROs.
