Applied Clinical Research & Consulting Group

Description

• 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 programs2.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 indication2.Review and due-diligence auditing of proposed CROs, research sites, and investigators3.Calculation of sample size and power4.Protocol development5.Representation before the FDA of clinical, regulatory, and biostatistical issues6.Ongoing site audits during enrollment and treatment7.Senior review of statistical analysis plans, and tables, listings, and figures8.Biostatistical support of DMCs/DSMBs9.Management of the NDA and PMA process10.QA/QI audits of IRBs and human research protection programs11.Gap analysis for those beginning their AAHRPP accreditation self-evaluation CRO services include:1.Clinical Affairs providing both clinical monitoring and project management services2.Clinical Data Services for both paper and EDC trials3.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 clients 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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  Headquarters:108 High Street , Winchendon, Massachusetts, United States

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  Phone Number: +1 888-663-1115

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  Website: https://www.appliedclinicalresearch.org

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  Employees:3

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  Revenue:$0 - 1M

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  Legal Name:Applied Clinical Research & Consulting Group

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• |  NAICS Code: 236115  |

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