SERVICES | Phase 1 Solutions

SERVICES

Each pillar reflects how I actually work inside a drug development team - not as a vendor,

but as an extension of your capability.

Phase 1 Solutions brings over 30 years of applied clinical science expertise to early phase drug development, spanning FIH, SAD, MAD, DDI, Food Effect, TQTc, human ADME, and special population studies across a broad range of therapeutic areas. Vance Warren functions as an embedded scientific resource — authoring, reviewing, and adjudicating protocols, ICFs, and CSR clinical sections with the precision that inspection-ready documentation demands. Real-time clinical data review and safety data trend identification are central to the service offering, ensuring that emerging signals are escalated to the medical monitor with the rigor and speed that early-phase risk management requires. Cross-functional scientific liaison — with pre-clinical teams, CROs, CPUs, and regulatory functions — is delivered with the fluency of someone who has held senior roles on both the sponsor and operational sides of the table. The result is a clinical science resource that integrates seamlessly into your study team and elevates data quality from pre-first dose activities through database lock.

PILLAR 1 OF 3

CRA/Monitor

Phase 1 Solutions delivers risk-based monitoring fully aligned with ICH E6(R2) and the operational realities of early-phase unit-based research, including SQV, SIV, IMV, and COV support calibrated to the compressed timelines and heightened safety expectations of Phase 1 and Phase 1b programs. Remote at-risk monitoring is incorporated as a proactive layer of oversight — enabling continuous data surveillance, early identification of protocol deviations, and real-time issue escalation without waiting for the next scheduled site visit. Site and vendor training for Phase 1 workflows is delivered with the authority of a consultant who has trained CRAs and study staff across major CROs and global CPUs, ensuring consistency in documentation quality, GCP adherence, and CAPA execution. Every monitoring engagement is conducted with an inspection-readiness mindset, treating each study record as if a regulatory auditor could request it tomorrow.

PILLAR 2 OF 3

Clinical Operations

Phase 1 Solutions provides end-to-end Phase 1 study management—from protocol profile and startup through database lock and CSR support—serving as an integrated extension of the sponsor’s early-phase team. CRO/CPU selection, RFPs, bid defenses, and contract negotiation are executed with sponsor strategy and budget as the governing framework, backed by direct pharma experience. Sponsor-side CRO and vendor oversight, according to the SOW, is rigorous, encompassing KPI governance, risk and timeline controlled, and escalation aligned to sponsor expectations. Sample logistics (acquisition, processing, shipment, and BA/PD lab reconciliation) are managed with the operational specificity required to protect PK/PD data integrity. With coverage across the USA and APAC member countries, Phase 1 Solutions supports multi regional execution without the coordination gaps that typically erode early-phase speed and quality.

PILLAR 3 OF 3

End-to-End Management

Startup through DBL and CSR support for Phase 1 and Phase 1b programs.

CRO / CPU Selection

RFP development, bid defense support, and vendor selection for early-phase partnerships.

Timeline & Budget Management

Proactive control of study timelines and budgets across the full Phase 1 lifecycle.