ABOUT

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

CLINICAL OPERATIONS

• Complete Life Cycle Project Trial Management
• Vendor Management
• Comprehensive Budget Management for Site or Sponsor
• Essential Document Preparation and Execution

MEDICAL AFFAIRS

• Cross Functional Team Support
• Clinical Strategy

CLINICAL LOGISTICS

• Unique Clinical SOPs/CRFs
• IFU, IB, and Labeling
• Clinical/Site Monitoring
• FHS – P1 HNV – Late Phase

REGULATORY AFFAIRS

• Understanding the IRB, EC, FDA, Health Canada, MHRA, EU-IVDR
• Submissions Process
• Development of supporting total quality and clinical SOPs

BUDGET & CONTRACTS

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

OPERATIONAL BEST PRACTICES

• Site and Sponsor Views
• 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
• Protocol Writing

Rates:

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