About

Clinical Affairs Solutions, LLC offers comprehensive and targeted solutions in the following ways:

MEDICAL AFFAIRS

• Study Protocol Review
• Protocol Amendment (improve performance)
• Clinical Strategy
• IFU, IB and Labeling Review

CLINICAL LOGISTICS

• Unique Clinical SOPs/CRFs
• Clinical Operations
• Clinical/Site Monitoring
• P1 HNV – Late Phase

REGULATORY AFFAIRS

• Understanding the CRF, IRB, EC
• Clinical Ramp Up
• SOPs

BUDGET & CONTRACTS

• Negotiation of Initial & FU
• Budget/Projections Reporting
• Monitoring for QA

OPERATIONAL BEST PRACTICES

• PI Training/Development
• Staff Training/Development (QA – GCP, ISO, ICH, HRPO, HIPPA)
• Standard Operating Procedure
• Metric Developing/Tracking

SAFETY

• SAE Assessment & SAUSAAR Reporting

RECRUITING/MARKETING/WRITING

• Ad Creation and Campaign
• Poster Development

Rates:

Contact Robin R Bruchas, MSW, CCPRP at casolutions3@gmail.com to start solving your clinical affairs!