Site Support
Clinical trials for biopharmaceuticals, medical devices, and diagnostics require the right people, protocols, data collection, and analytic tools. Simply put, a lot can go wrong during a trial that can cost a company significant time and money. Pearl Pathways will support you when things go wrong, but we don’t merely want to fill in the gaps. Our experts will help your team work smarter and more efficiently.
Equipped with a wide breadth of knowledge and experience, our advisors can do what you need:
Study Identification
- Develop site strategies to find new clinical trials
- Connect sites with sponsors
- Assist sites with data analysis and metric development for marketing
Site Support
- Study coordinator support
- Provide on-site coordinators for PI
- Case report form (CRF) development for site use
- Standard operating procedures (SOPs) writing
- Remediation services
Budgets and contracts
- Develop site budgets for clinical trials
- Negotiate site budgets with sponsor
Training and education
- Entry-level CRC & CRA training
- FDA audit/inspection preparation
- FDA Form 483 and warning letter response
- Corrective and preventative action (CAPA) development
- Good clinical practice (GCP) training
- IRB and Human Subject Protection – beginner and advanced
- Quality system requirements for research sites
IRB study reviews
- Through our AAHRPP accredited independent review board, Pearl IRB
IRB non-study support review
- Audits of internal processes to prepare for AAHRPP audit, etc.