| |
Clinical Development Services
Goal-oriented, customer-centric services to biotechnology and pharmaceutical clients assisting in the areas of regulatory, medical writing, data and project management, monitoring, safety, and more.
Clinical Consulting Services
Study-specific expertise and best-practice recommendations in a variety of fields including: regulatory pathway evaluation, approval-oriented drug development planning, scientific due diligence of partnered compounds, project management and auditing, international regulatory representation and compliance, and more.
Clinical Trial Management Services
Compound and drug approval runway services, including:
- Clinical monitoring (site qualification, documentation, management and site close-out, etc.)
- Medical writing (proposals, FDA pre-meeting packages, Advisory Committee briefings, regulatory strategy, clinical study reports, FDA meeting minutes, etc.)
- Comprehensive project management (grant negotiation and payment, budget and timeline oversight, communication, oversight of CRA and project team, etc.)
- Data Management (CRF design, database design and deployment, data, validation, query and data archiving, etc.)
Electronic Data Capture (Biostatistics)
Clinical trial study design and execution developed to meet regulatory and business objectives, through multi-stage statistical analysis and reporting (from compound development, manufacturing and marketing), presentation of statistical data to regulatory authorities, consultation across the spectrum of research (from discovery, to Phase I-IV trials, clinical development, through go-to-market recommendations), and much more. |
