Clinical Operations Support

• Intelligent early phase study planning to maximize the potential for generating robust PK/PD data sets
• Phase I unit identification, evaluation, and management
• Early phase study execution support or direct management of study protocols
• Investigator meeting support
• Study enrollment planning and troubleshooting
• Establishment of monitoring guidance and expectations
• Development of study documents and site tools
• Vendor RFP development and bid proposal negotiation assistance
• Clinical R&D process development & improvement

Project Management

• Timeline development and upkeep
• Identification and management of outsourcing resources (CROs and vendors for central labs, central IRBs/ECs, IVRS, electronic data capture/eCRF, eDiary, manufacturing, bioanalytical, Phase I units, advertising agencies, etc.)
• Study/trial master file evaluation