Site Monitoring
Cancer Research And Biostatistics (CRAB) provides clinical monitoring in accordance with FDA regulatory requirements (21 CFR part 312.50 and 21 CFR part 312.56) and Good Clinical Practices guidelines. CRAB’s monitors are experts in the field of data management and oncology research.
Monitoring visit services include:
- Pre-study/site qualification visit
- Site initiation visits
- Interim monitoring visits
- Close-out visit
CRAB’s monitoring experience spans all types of trials from large-scale prevention studies, to Investigator-initiated/sponsored studies (IIT/IST), to Phase I-IV industry sponsored trials.
Our monitors provide on-site review of regulatory documents, drug accountability records, queries, case report forms and source documents to ensure the clinical trial is being conducted according to the protocol and good clinical practice guidelines. Subject charts are closely reviewed to confirm eligibility and protocol compliance. In addition, site monitors provide on-site training to site staff as needed and requested, to ensure compliance with protocol and study procedures. Detailed reports are provided to both the client and site investigator at the conclusion of each visit.
CRAB monitors are dedicated research professionals who provide quality clinical monitoring services for their clients. Our monitors work closely with project and data management team members at CRAB to ensure each client’s regulatory and compliance requirements are met with success and satisfaction.
Project Management
We view our clients as partners with CRAB. We translate this philosophy into action within our project management team. Our project managers bring together a full range of services and experience to meet our clients' needs. We provide services to our clients from large pharmaceutical companies and consortiums to small startups. Depending on our clients' needs and experience, we tailor our team and approach. Our clients benefit from many years of experience with both oncology clinical trials and project management. We have demonstrated our ability to successfully support the launch of First-in-Human studies through pivotal Phase III global clinical trials.
At CRAB, our project managers are responsible for the overall conduct of a clinical study. Our managers not only ensure your project is on time and on budget, they provide you with high quality support from beginning to end. Project management tasks available to your study include, but are not limited to:
- Overall clinical study management
- Management of high-level timelines/milestones
- Development of customized eCRFs for data capture
- Site start-up activities
- Primary contact for all trial related activities
- Regular reports/updates