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Quality Assurance Services
Case Study
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QA is critical and vital in GxP (GCP, GLP and GMP). MakroCare's QA auditors have solid experience in auditing along with in-depth knowledge of ICH-GCP, FDA, EMEA and local regulatory guidelines. MakroCare can offer a comprehensive range of tailored services including.
- Clinical Auditing Services
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MakroCare provides a full range of clinical audits from phase I to phase IV studies on an international basis. Following each audit, comprehensive and confidential reports and audit certificates are produced according to MakroCare standard operating procedures or client specifications. Clinical Audits encompass all aspects of the clinical development process.
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Trial Master File Audits
- Comprehensive review of essential documents according to ICH GCP, Directive
2001/20/EC and client SOPs.
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Investigator Site Audits
- Audits of pivotal or supportive studies involving single or multiple
investigator sites on a worldwide basis.
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Phase 1 Unit Audits
- Review of facilities, equipment, procedures and personnel, either pre-study
or during study conduct.
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CRO and Clinical
Laboratory Audits
- Pre-contractual audits, evaluation as preferred service providers or audits
involving ongoing projects.
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Database Audits
- Audit of a sample of data from a locked database according to either the
client or MakroCare SOPs.
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Clinical Report Audits
- Audits of clinical reports against client SOPs and ICH GCP requirements.
- Quality Management Consulting
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Companies performing clinical development internally are becoming increasingly concerned about whether their systems are working efficiently and are compliant with current regulatory requirements. One of the challenges companies face is being able to meet regulatory expectations with limited resources, whilst remaining competitive.
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MakroCare has a team of highly experienced and knowledgeable consultants who can independently and objectively assess existing quality systems to identify gaps or deficiencies. The Consultants provide valuable input into optimising systems to ensure a high quality output. Examples of systems that have been assessed include.
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Clinical Operations
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Data Management and
Biometrics
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Outsourcing and
contracting
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Pharmacovigilance
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Quality Assurance
- Computer System Validation Audits
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MakroCare provides a comprehensive Computer Systems Validation (CSV) audit service.
- SOP Development
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MakroCare can provide comprehensive standard operating procedures (SOPs) according to client specifications and ICH GCP requirements.
