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About Applied Clinical Research & Consulting Group

Our company consists of two major divisions: 1. CONSULTING - expert consulting in all aspects of clinical trials, AAHRPP accreditation, and development/improvement of human research protection programs 2. CRO (contract research organization) – full-service CRO, with deep experience in clinical monitoring, project management, biostatistics, and regulatory. CONSULTING activities include: 1. Recommendations of sites based on therapeutic indication 2. Review and due-diligence auditing of proposed CROs, research sites, and investigators 3. Calculation of sample size and power 4. Protocol development 5. Representation before the FDA of clinical, regulatory, and biostatistical issues 6. Ongoing site audits during enrollment and treatment 7. Senior review of statistical analysis plans, and tables, listings, and figures 8. Biostatistical support of DMCs/DSMBs 9. Management of the NDA and PMA process 10. QA/QI audits of IRBs and human research protection programs 11. Gap analysis for those beginning their AAHRPP accreditation self-evaluation CRO services include: 1. Clinical Affairs – providing both clinical monitoring and project management services 2. Clinical Data Services – for both paper and EDC trials 3. Biostatistics – providing a broad range of experience from phase I-phase IV, and multivariate analyses for specialized applications. 4. Medical Writing – providing cost-effective services, using either the client’s style guide, or our own. 5. Pharmacovigilance – working with sites to provide quality safety data, and early and complete event reporting, providing full-service for DMCs/DSMBs (administration, member recommendation, charter development, biostatistical support)

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