Phase I & Phase II QMS
Entering clinical development changes the quality responsibilities of a biotech or pharmaceutical company. As a clinical trial sponsor, you need more than controlled documents. You need a Quality Management System that supports sponsor oversight, clinical trial activities, service providers, safety, deviations, CAPA and regulatory compliance throughout the trial lifecycle.
WHAT YOU NEED
Build a scalable QMS for clinical development.
The OZQA Phase I/II QMS provides a practical and scalable quality framework designed for biotech and pharmaceutical companies conducting early stage clinical trials.
Already have a foundational QMS?
Add the Phase I/II module.
Ideal for:
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Existing OZQA Preclinical QMS customers
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Companies with established core quality processes but limited clinical Sponsor procedures
Add the clinical and GCP processes required to evolve your existing quality system into a clinical Sponsor QMS.
THE PHASE I/II QMS MODULES
A QMS designed for Phase I and Phase II sponsors.
Phase I and Phase II share many of the same fundamental GCP sponsor responsibilities. Rather than creating separate quality systems for each clinical phase, OZQA provides a combined Phase I/II QMS that can scale as your clinical programme grows. The system builds on the core quality processes established during preclinical development and introduces the additional processes needed for clinical trial sponsorship.
Defines the structure, scope and principles of your Quality Management System.
Establish how potential serious breaches of GCP or the clinical trial protocol are identified, assessed, escalated and reported where required.
Defines the respective responsibilities of operational and the Quality Unit and how quality related decisions, oversight, escalation etc. activities are managed.
The process provides a structured framework for assessing, approving, implementing and documenting significant changes before they are introduced.
Defines responsibilities and workflows for the identification, assessment, documentation, escalation and reporting of safety information during clinical trials.
Supports GDP and data integrity principles, ensuring that records remain reliable, attributable and inspection ready throughout clinical development.
Establish a structured process for quality issues, investigating root causes, implementing corrective and preventive actions and verifying their effectiveness.
The process establishes a risk based approach to assessing and overseeing external organisations performing activities on behalf of the sponsor.
SPONSOR BIOTECH COMPANIES
Sponsor oversight cannot simply be outsourced.
Many early stage biotech companies operate with small internal teams and outsource a significant proportion of clinical development. A CRO may manage the trial. A specialist vendor may manage clinical data.
Another provider may perform pharmacovigilance activities. Clinical sites conduct the trial. But outsourcing activities does not remove the sponsor's responsibility for appropriate oversight.
Your QMS should clearly establish:
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What has been delegated?
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Who is responsible for each activity?
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How are service providers selected and qualified?
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How does the sponsor maintain oversight?
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How are quality issues escalated?
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How are risks identified and managed?
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How does the sponsor know that delegated activities are being performed appropriately?
The OZQA Phase I/II QMS is designed with outsourced and virtual biotech operating models in mind.
WHAT YOU NEED
Designed for small and virtual biotech companies.
The OZQA Phase I/II QMS provides a practical quality management system designed specifically for early stage biotech and pharmaceutical companies.
Start with the processes that matter today. Add the phase III and marketed products modules when your development programme progresses.
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DEVELOP ALONGSIDE YOUR PRODUCT
Start simple. Scale when you need it.
The transition from preclinical development to the first clinical trial is one of the most important quality milestones in drug development.
The goal is not to create unnecessary complexity. It is to establish a QMS that reflects your actual responsibilities as a clinical trial sponsor.
Pharmaceuticals
Processes that were appropriate for a small preclinical organisation may no longer be sufficient once patients are enrolled and activities are performed under Good Clinical Practice. Sponsor responsibilities increase significantly. Your organisation must be able to demonstrate appropriate control and oversight of clinical activities, even when much of the operational work is outsourced to CROs, laboratories, clinical sites and other service providers.
Preclinical
Move from having procedures to operating them consistently. Strengthen oversight, documentation, training and Quality governance as clinical activities and external partnerships increase.
Phase I & Phase II
Move from having procedures to operating them consistently. Strengthen oversight, documentation, training and Quality governance as clinical activities and external partnerships increase.
Bring together the documentation needed to support product safety, ingredients, manufacturing, claims and regulatory compliance. Ensure regulatory, product and Quality documentation is aligned before commercial distribution begins.
EU PV
Quality does not end at approval. Maintain oversight, pharmacovigilance, supplier control, CAPA, audits and continuous improvement throughout the product lifecycle.
Phase III
Ensure Quality systems, governance and documentation are mature enough to support late stage development and the transition towards regulatory submission and commercial operations.
MAH
Prepare the organisation for the transition from development into marketed product responsibilities, including ongoing Quality oversight, pharmacovigilance and relevant commercial Quality processes.
READY TO USE QUALITY CONTENT
Documents are only the beginning.
Start with our templates and add as much implementation support as your organisation needs.
BUILT TO WORK TOGETHER
Not just individual templates.
Our products are developed as parts of connected Quality processes. Procedures define how the process works and forms capture the required evidence, and related processes connect one document with the wider QMS.
WHY QMS
Use your existing eQMS or let us help you choose one.
The OZQA Phase I/II QMS is system independent. You are not required to purchase a specific software platform to use our documentation. The QMS can be implemented within an appropriate existing system or eQMS. If you are moving from a simpler preclinical setup into a dedicated electronic QMS, OZQA can also help define your requirements and assess suitable solutions. The system should support your quality processes and regulatory responsibilities – not dictate them.
GXP DEVELOPED STANDARDS
Built by life science QA professionals
OZQA combines practical quality and regulatory experience with ready to implement QMS documentation. Our approach is designed for organisations that need a compliant and scalable quality framework without building unnecessary complexity into their operations. Whether you are developing your first therapeutic candidate or preparing to move towards clinical development, we help you implement the level of quality management that is appropriate for where you are today.
 GMP |  GVP |
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 GCP |  GDP |
FREQUENTLLY ASKED QUESTIONS
FAQ
Building a Quality Management System during preclinical development often raises practical questions. How much QMS do you actually need? Which SOPs should be implemented first? Do you need an electronic QMS? And what happens to the system when your first clinical trial approaches?
The right answer depends on your development stage, organisation, outsourced activities and regulatory roadmap. A preclinical QMS should therefore be proportionate to the activities you perform today, while providing a foundation that can grow with your organisation.