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Pharma:
EZ Solutions knowledge and expertise
covers the huge spectrum of innovative
projects in the life sciences industry,
including clinical trials systems, validation
systems, FDA/21CFRPart11 compliance,
web-based reporting, patient monitoring
systems, electronic data capture, and
bioinformatics.
From bioinformatics to clinical trials we deliver solutions that help utilize information effectively and transform key business practices. With an unparalleled dedication to quality, we help our clients prioritize, plan, and implement the right technology solutions to meet their needs.
Validation systems
Our competence in areas such as FDA
governance and stipulations enables
our clients to meet FDA guidelines while
embracing new technologies. Our experts
help clients develop and enhance their
capabilities in a variety of areas.
Addressing all sectors of the industry, EZ Solutions Telecom industry practice delivers a wide range of solutions.
- Validation systems - provide a unique blend of relevant and current knowledge, tools, and approaches to maintain all FDA-governed IT systems in a validated state.
- 21CFRPart11 compliance - performs Electronic Record Electronic Signature (ERES) compliance studies; ensures integrity in system operations; prepares audit trails and develops validation policies and procedures and related documentation.
- Clinical trial processes - Streamlines the process of building a complete, error-resistant system for entering, verifying, and managing clinical trial data.
Pharmaceutical manufacturing and medical device products and services.

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Pharmaceutical and medical device manufacturers |

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Ensure FDA compliance |

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Ensure FDA compliance. |

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Methodologies and tools |

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Understanding good clinical,
laboratory, and manufacturing
practices (GxP)
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Customized applications |

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Target identification |

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Analytical capabilities |

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Compliance studies |

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Maintain process to ensure continued compliance |

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Biometric fingerprinting |

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Preparation of audit trail |

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Implementation of ERES solutions |

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Web portals |

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CRM implementation |

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Data warehousing and data mining |

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ERP solutions |

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Application maintenance and process management |

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New application development |

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Electronic data collection (EDC) |

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FDA reporting |

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Project based |

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Long-term strategic relationship |

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Support data collection |

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Aggregate data for clinical and managerial analysis |

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FDA governance and stipulations (SOP, GxP, etc.) |

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Core drug testing processes |
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