BioBoston CRO

Clinical Research Consulting Services

BioBoston CRO provides targeted clinical research consulting services designed for biotechnology, pharmaceutical, medical device, and diagnostic organizations that need experienced support without a full-service CRO transfer. The company's flexible engagement model allows sponsors to maintain accountability while accessing specialized expertise in defined workstreams.

Service Areas

Regulatory & Medical Writing

• Protocol writing and submission planning
• FDA briefing book and clinical study report writing
• Investigator brochure support
• Regulatory pathway guidance
• Safety and efficacy summaries
• Labeling support

Clinical Data Management & Biostatistics

• Data management plan review
• eCRF design and review
• EDC build and database design
• EDC vendor qualification
• Biostatistical support

Clinical Quality Assurance

• GCP audits and CAPA support
• Mock FDA inspections
• Quality management and sponsor oversight
• TMF audits

Clinical Operations & Project Management

• Clinical study management
• Clinical project management and timeline management
• Budget tracking and responsibility matrix definition
• Trial rescue management
• Vendor governance
• Product development planning

Engagement Model

BioBoston positions itself as a specialist CRO services provider that assembles experienced professionals around the sponsor's specific gaps. Depending on the need, the company may advise sponsors, produce defined deliverables, embed specialists, independently assess programs, oversee outsourced activities, or coordinate multiple contributors. The model emphasizes keeping strategy, documents, data, quality, and delivery aligned across functional boundaries.