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oracleclinical.net

Oracle Clinical

PSC Clinical

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Oracle Clinical

http://oracleclinical.net/services/shipping-validation/clinical-quality-assurance

Regulatory and 21 CFR Part 11 Audits. Medical Monitoring and Safety. Good Clinical Practices Training. Compliance Triage and Regulatory Responses. SVMS Steam Quality Test Kits. Regulatory and 21 CFR Part 11 Audits. Training, Workshops and Documentation. Preapproval Inspection (PAI) Assistance. Our legacy data migration method includes the following key steps:. Evaluation of your data resources. Detailed requirements defined for conversion. A project plan with a milestone timeline is developed.

2

Oracle Clinical

http://oracleclinical.net/resources

Regulatory and 21 CFR Part 11 Audits. Medical Monitoring and Safety. Good Clinical Practices Training. Compliance Triage and Regulatory Responses. SVMS Steam Quality Test Kits. Regulatory and 21 CFR Part 11 Audits. Training, Workshops and Documentation. Preapproval Inspection (PAI) Assistance. Pharmaceutical Services provides experienced professionals for contract assignments, direct hire staffing, and off-site placement. PSC has a large database of both active and passive job seekers in the clinical...

3

Oracle Clinical

http://oracleclinical.net/services/shipping-validation/clinical-quality-control-and-monitoring

Regulatory and 21 CFR Part 11 Audits. Medical Monitoring and Safety. Good Clinical Practices Training. Compliance Triage and Regulatory Responses. SVMS Steam Quality Test Kits. Regulatory and 21 CFR Part 11 Audits. Training, Workshops and Documentation. Preapproval Inspection (PAI) Assistance.

4

Oracle Clinical

http://oracleclinical.net/services/shipping-validation

Regulatory and 21 CFR Part 11 Audits. Medical Monitoring and Safety. Good Clinical Practices Training. Compliance Triage and Regulatory Responses. SVMS Steam Quality Test Kits. Regulatory and 21 CFR Part 11 Audits. Training, Workshops and Documentation. Preapproval Inspection (PAI) Assistance. Successful migration of clinical research or drug safety data through a predictable and validated conversion process. Company-specific software tools and techniques to assist in seamless data migration.

5

Oracle Clinical

http://oracleclinical.net/services/shipping-validation/ind-submissions

Regulatory and 21 CFR Part 11 Audits. Medical Monitoring and Safety. Good Clinical Practices Training. Compliance Triage and Regulatory Responses. SVMS Steam Quality Test Kits. Regulatory and 21 CFR Part 11 Audits. Training, Workshops and Documentation. Preapproval Inspection (PAI) Assistance. Advise on requirements and format. Assist preparation of data to support your application. Prepare, assemble, and review the required documents and reports. Pre-IND and NDA meeting briefing packages.

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SAP Validation

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Oracle Clinical

Regulatory and 21 CFR Part 11 Audits. Medical Monitoring and Safety. Good Clinical Practices Training. Compliance Triage and Regulatory Responses. SVMS Steam Quality Test Kits. Regulatory and 21 CFR Part 11 Audits. Training, Workshops and Documentation. Preapproval Inspection (PAI) Assistance. We offer a broad range of consulting and development services for the Oracle Pharmaceutical Application (OPA) suite and have extensive experience in many aspects of this important clinical data management system.

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