Functional Services

As YNB believes that "Quality Brings Speed," we provide strong, detailed services for Quality Assurance.​

• Assess internal management structure, manpower, activities related to clinical development and Advise to set up the economic quality structure, Provide appropriate solution for sponsor to have appropriate & economic operational structure and working process.

• SOPs development or SOP evaluation

• Quality management planning for sponsor 

• Risk Assessment & Management Planning

• CRO & Site audit, Issue & CAPA management support

• Periodical compliance review for ongoing clinical research activity

• Clinical Staff (PM, CRM, QA in CRO or sponsor) Evaluation & Consult

• Training for Quality Activity for Staff or critical management 

• Support your ability to ensure the proper control process through drug lifecycle with the following quality practices:

  • Quality System Design, Assessment, and Implementation –  Quality system development, data integrity, risk management, training and qualification of staff, gap analysis with new/revised standards and regulations

  • Quality Operations – Management review, validation and qualification, risk management, exceptions, change management, CAPAs

  • Quality Systems Auditing and Assessment – Sponsor’s audits, internal audits, third party oversight

Project Management is crucial, as it affects every steps of the process. We will help you to build strong foundation, providing following services:

• Study timeline setup and establishment of recruitment strategies and booster plan​.

• Vendor, CRO, Country, Site Selection and Management

• Study Budget & review​

• Issue/ Supplies/ Risk Management 

• Development of system and process​

• Study documents(instructions, manuals, plans, etc.)​

Pre-study SCM services include setting up supply plan and budget, selecting and managing vendor​, participating in system set up(IWRS/CRF), prepare and review document(SOP, Protocol, CRF, Pharm manual, etc), and Manage Packaging, Shipping and Storage.

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During the study we provide supervision of supply, stock, budget, documentation, update IP(Relabel IP), and issue escalation and resolution such as shipping error or temp excursion.

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Post-study services include management of return and destruction, reconciliation of IP and budget, and confirmation of document completeness.

YNB provides strategy consulting in product development, product approval, and pre-IND communication. We will guide you with professional regulatory strategy and execution, filing strategies. We also can offer CTD Preparation for IND/NDA submission and regulatory submission. With our members' strong networks in pharmaceutical industry and health authority, we will support you through the whole process.