Trialwise is a woman-owned, boutique clinical research organization (CRO) specializing in early phase clinical studies and niche consulting. We intentionally partner with a limited number of biotech and pharma clients to offer a customized approach to managing projects efficiently without compromising quality, accuracy, or adherence to protocol and regulatory compliance. Since our inception, Trialwise has operated as a decentralized team working cross-functionally in an environment unencumbered by silos and bureaucracy. Our collaborative approach with our clients ensures we deliver the quality, personal attention, and cost efficiencies on which Trialwise has built its reputation. Trialwise president, Beth Brinsdon, founded the company in 1999 after two decades in the pharmaceutical industry. She observed that start-up and small-to-midsize biotech companies in the early stages of drug development require a high level of personalized service, a level that can be best provided by a small CRO. In 2015, she renamed the company to Trialwise and began scaling operations with a remote team to collaborate with select clients ranging from start-ups to established bio-pharma companies. The Trialwise approach is attentive, flexible, proactive, and committed to the highest quality industry standards in the following areas: - Protocol Development - Site Qualification - Risk Identification and Assessment - Study Start-up - Database Development and Management - Risk-based Management - Traditional Monitoring - Statistical Programming of CDISC Compliant Datasets - Statistical Analysis - Quality Assurance Oversight - Clinical Study Report Development - Document Processing and eCTD Compliant Granular ePub - Clinical Trial Registration and Results Disclosure - Staffing Support