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Clinical Trials are becoming more complex, involving more diverse countries, regulatory compliance guidance, clinical study patient documentation and on-time delivery, monitoring, control, and reporting of dated materials, services and suppliers. Sponsors are finding it challenging to plan, organize, source, and deliver consistent trial-related drugs, materials and services to multiple locations around the world.
Drawing on our unique fusion of scientific, regulatory, technical, and business expertise, Ancillare provides flexible, strategic solutions designed to fit your specific products, stage of development, and company size and goals. Our integrated approach helps pharmaceutical, biopharmaceutical and medical device companies shorten time to market, reduce risk, meet schedules, reduce trials costs, access new global markets, and leverage the latest technology to maximize portfolio value.
Ancillare provides the expertise network and track record required to provide all of the products, services and documentations needed to achieve protocol success through one source.
Our proven services include:
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Provide CFR, EU, EC, WHO, ICH Q7, ISO Regulatory Compliance, Labeling, Change Monitoring and Notification |
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Internal and External CGCP, CGMP, CGLP Quality and Regulatory Compliance Audits to ensure the highest quality materials and services for your protocol |
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Encapsulation and blinding services |
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Labeling, kitting, shipping and monitoring |
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Authenticity assurance and global quality control |
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Investigator site training and compliance |
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Storage solutions and JIT supply |
Ancillare becomes a vested and accountable partner in the clinical trial team and understands the overall project schedule, specific materials required, labeling and country regulatory requirements, clinical locations and global logistics challenges. As a strategic partner, we are able to identify potential obstacles and recommend and implement effective strategies and solutions to eliminate or reduce any risks to the study schedule, costs or results.
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Single-source Clinical Partner:
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Manage protocol requirements |
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Identify clinical services needs
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Clinical services including labeling, encapsulation and blinding strategies
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Full process compliance |
Benefits:
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Ensure protocol success |
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Global regulatory compliance
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Process audits for quality assurance
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Services management and process analysis |
Ancillare In Action:
Labeling success on a short notice.
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