Navigate the Complexities of Clinical Research with Confidence 

QDraft QMS implementation Support 

The clinical research landscape is driven by innovation, but also by strict regulations. Ensuring the safety of participants, the integrity of data, and compliance with guidelines like ICH-GCP (International Council for Harmonisation of Good Clinical Practice) is paramount.

That's where QDraft Quality Management System (QMS) Implementation Support Services come in. We partner with you to develop a robust QMS that streamlines your research processes, minimizes risks, and guarantees adherence to all applicable regulatory requirements. 

Why Quality Management System?

• Confidence in Compliance: We have extensive experience navigating the complexities of QMS implementation in line with ICH-GCP and other pertinent regulations in the clinical research domain. We'll guide you through every step of the QMS development process, ensuring your studies meet the highest standards.

• Reduced Risks, Enhanced Safety: A well-designed QMS proactively identifies and mitigates potential risks throughout the research lifecycle. This protects your participants and safeguards the integrity of your data.

• Streamlined Processes, Increased Efficiency: Clear and consistent procedures established within your QMS eliminate confusion and redundancy. This leads to smoother workflows and faster study completion times.

• Improved Data Quality: QMS emphasizes consistent and accurate data collection and recordkeeping. This ensures your research findings are reliable and trustworthy.

• A Foundation for Success: A well-implemented QMS becomes the cornerstone of your research quality culture. It fosters continuous improvement and positions you for success in the competitive world of clinical research.

Our Services

• QMS Gap Analysis and Needs Assessment: evaluation of your current practices and identify areas where we can add value to your QMS effectiveness.

• Quality Manual and Policy Development: provision of technical support to craft a comprehensive Quality management description through a an effective Quality Manual that outlines your organization's commitment to quality and establishes clear expectations for all processes that govern the activities.

• SOP Development and Implementation:  We help you to improvise and enhance Standard Operating Procedures (SOPs) for all your research activities.

• Risk Management Plan Creation: We provide guidance on the process of identifying, assessing, and mitigating potential risks associated with your research.

• Document and Template Design: We provide support to develop and standardize forms, formats, flowcharts, and templates that are needed to ensure efficient and consistent data collection.

• Training and Ongoing Support: We provide comprehensive training for your staff on the QMS and its implementation, and offer ongoing support to ensure its continued effectiveness.