Foresight Regulatory Strategies
Consulting firm providing clinical, regulatory, quality and data services to medical device, pharmaceutical and biologic companies. Services span clinical program design and management (Phases I–post-approval), protocol and CRF development, investigational site recruitment and monitoring, regulatory strategy and submissions, quality system development and auditing, non-clinical testing oversight, and regulatory-compliant data management and reporting. Primary specialization in ophthalmic devices; clients also include developers of pharmaceuticals, biologics and other medical products.
Industries
Nr. of Employees
small (1-50)
Foresight Regulatory Strategies
Services
Consulting to design clinical evaluation programs and regulatory plans from early-phase studies through post-approval.
Protocol authoring and CRF creation following ICH/ISO guidance to ensure appropriate data capture and site usability.
Detailed project planning, milestone tracking and program management for clinical projects and programs.
Site identification, validation, contracting and IRB/ethics committee support.
On-site monitoring, monitoring plan development, adverse event support and inspection preparation/assistance.
Database design, validation, data cleaning, AE coding and generation of SAS-native output files.
Consulting to design clinical evaluation programs and regulatory plans from early-phase studies through post-approval.
Protocol authoring and CRF creation following ICH/ISO guidance to ensure appropriate data capture and site usability.
Detailed project planning, milestone tracking and program management for clinical projects and programs.
Site identification, validation, contracting and IRB/ethics committee support.
On-site monitoring, monitoring plan development, adverse event support and inspection preparation/assistance.
Database design, validation, data cleaning, AE coding and generation of SAS-native output files.
Expertise Areas
- Clinical trial design and management
- Regulatory strategy and submission preparation
- Quality systems and auditing (QSR/ISO)
- Clinical data management and SAS-based reporting
Key Technologies
- 21 CFR Part 11 compliant clinical databases
- SAS-based data output and analysis
- ICH and ISO guidance for clinical protocols
- Good Laboratory Practices (GLP) auditing