OUR SERVICES
How QARA Can Assist You
Discover more about our extensive range of professional services. We constantly update this page, but if you still can’t find what you’re looking for, please feel free to get in touch with us – we will be more than happy to help.
Quality Assurance
QMS development
SOP Universe
Training Universe
Deviation Management
Audit & Inspection
Regulatory Affairs
Submission Advice & Planning
Technical Writing
Ethical & Regulatory Approvals
Quality Assurance Services
SOP Universe
Controlled documents like Policies, SOPs, Work Instructions, Guidelines, Templates, Forms, and Checklists form the backbone of any quality-driven business—collectively known as the SOP Universe. It's essential that your SOP Universe is robust, compliant, and efficient for smooth audits and inspections.
QARA offers services to develop a new SOP Universe or remediate existing SOPs based on audit/inspection findings.
- Process Mapping: Develop or remediate SOP Universe, ensuring interface between departments and teams.
- Document Writing: Create or update documents, including flowcharts.
- Regulatory Compliance Review: Ensure documents meet applicable regulations.
Training Universe
Ensuring your staff are adequately qualified, experienced, and trained is a core GxP requirement. A one-size-fits-all training approach is neither efficient nor effective. In addition to offering training materials or sessions to staff, individualized training needs assessments and competency assessment mechanisms are necessary.
QARA consultants are passionate about learning and teaching, having completed formal Train-The-Trainer courses. We can assist in various areas.
- Training Strategy: Develop a training policy and needs assessment process.
- Training Program: Design a comprehensive program for essential training areas.
- Training Sessions & Materials: Create and deliver training in key GCP/GVP areas.
Deviation Management
Even with meticulous planning, deviations can occur in GxP areas. Safeguard patients, data, and products by swiftly and thoroughly addressing these issues. Deviations can present growth opportunities if managed correctly and should be part of your continuous improvement strategy. Regular trend analysis helps enhance your business year after year.
Effective investigation, assessment, and risk-proportionate remediation are skills honed over time. QARA consultants bring a wealth of expertise in this field, taking the worry out of your deviation management.
- Deviation & CAPA Handling: Provide real-time advice and manage the deviation process.
- Expedited Serious Breach Management: Assess and report serious breaches.
- Trend Analysis: Analyze deviations to inform continuous improvement.
Audit & Inspection
GxP compliance mandates that businesses perform internal audits of their trials and systems/processes. They will also host external audits from clients and may be involved in inspections by regulatory bodies like the MHRA or FDA.
A well-functioning QMS ensures your business is audit/inspection ready at all times. However, audits and inspections can be stressful and resource-intensive. Having well-prepared materials and trained staff can make the process smoother and more pleasant for all involved. A defined strategy for internal auditing ensures balanced, risk-adapted use of your internal resources. QARA can assist with both aspects of the Audit/Inspection Universe as follows.
- Internal Audit Strategy & Schedule: Develop and implement a risk-adapted audit strategy and annual schedule.
- Internal Audit Performance: Conduct independent internal audits and manage responses.
- External Audit/Inspection Preparation & Hosting: Development of storyboards and standard slide decks for the business, tailored to each external audit/inspection, with real-time advice and support during conduct.
- External Audit/Inspection Response: Guide responses to findings and develop remediation plans.
QMS
A robust Quality Management System (QMS) is vital for any business, especially in GxP areas like GCP and GVP. A solid QMS relies on SOP Universe, Training, Deviation Management, and Auditing. While a manual QMS (e.g., Excel) works, growing businesses benefit from an electronic QMS (eQMS), the gold standard. Whether off-the-shelf or developed in-house, proper development or customization and implementation are crucial.
QARA can assist start-ups needing a QMS from scratch, established businesses requiring QMS review and remediation, or companies undergoing mergers or divestments needing QMS integration or separation.
- Initial Development: Design and implement a comprehensive QMS.
- Assessment: Conduct gap analysis and review existing QMS, with detailed reporting and remediation plans.
- Change Management: Provide advice on merging/divesting existing QMS and change control.
- eQMS: Assist with specification writing, selection/qualification, user testing, implementation, and training material development.
Regulatory Affairs Services
Submission Advice & Planning
Clinical trials are costly and must be well-managed to stay on time and within budget. Ensuring timely regulatory and ethical approvals is critical and requires meticulous planning. Delays or rejections can occur if regulatory compliance is not well understood from the outset. For instance, US-based sponsors need a Legal Representative in the EU or UK for trial approval, which must be pre-planned.
QARA has extensive experience in clinical trial submissions and offers comprehensive advice on submission planning, whether or not we prepare and submit the applications.
- Road-mapping In-country/Region Regulatory Requirements: Advice and guidance on regulatory requirements (incl. Legal Representatives, Sponsors/Applicants, GDPR Representatives).
- Submission & Approval Timeline Planning: Develop timelines for application pack collation, submission, and approval.
Technical Writing
CTA applications need numerous documents like in-depth forms (e.g., IRAS) and Cover Letters, which require regulatory expertise. Other key trial documents, such as protocols and informed consent forms, also benefit from expert review to meet regulatory and ethical requirements.
QARA can assist with writing your regulatory application documents and ensuring protocol and consent documentation comply with submission requirements.
- Regulatory Documentation Development: Draft application forms/portal submissions, cover letters, and statements.
- Regulatory Compliance Review: Ensure protocol and consent document regulatory compliance.
Obtaining Ethical & Regulatory Approvals
Clinical research project approval requirements vary across countries/regions and project types. The EU and UK have combined regulatory and ethical approval processes to streamline submissions. However, some businesses still split regulator and ethics submissions across teams, compromising efficiency.
QARA consultants have extensive experience obtaining both regulatory and ethical approvals from start to finish. We can guide you and your teams or obtain approval on your behalf.
- Collating Dossiers: Determine application pack content requirements and coordinate with the trial team to assemble complete packs.
- Performing Submissions: Execute submissions via email or computerized systems, such as IRAS (UK), CTIS (EU), BASEC (Switzerland), New Zealand (Ethics RM).
- Handling Queries and Requests for Further Information (RFIs): Respond to regulatory and ethical queries within required timescales.
Consultancy
Vendor Management
Ensuring that your vendors comply with regulatory and quality standards is crucial for the success of your clinical trials. It is a key responsibility of clinical trial sponsors, consistently scrutinized during regulatory inspections. QARA provides comprehensive vendor management services to help you select, monitor, and assess your vendors. We ensure that your vendors meet your quality expectations and regulatory requirements, thereby minimizing risks and enhancing the overall quality of your trials.
- Vendor Selection & Qualification: Support the GxP assessment of clinical trial vendors and suppliers, with detailed requirements specifications.
- Performance Monitoring: Design and implement risk-based approaches to continuous assessment, including auditing.
- Quality Technical Agreement: Negotiate terms to ensure high standards of quality and compliance.
Risk Management
Effective risk management is essential for the success of clinical trials. QARA offers comprehensive risk-based services in various areas. Our experts identify potential risks, assess their impact, and develop mitigation strategies to ensure the smooth execution of your trials. We also conduct regular reviews to ensure that your risk management plans remain relevant and effective.
- Clinical Trial Risk Assessment: Working up your trial’s risk assessment and ensuring mitigation strategies are integrated into the protocol and plans.
- Risk-Based Monitoring (RBM) Planning: Developing RBM plans, focusing on the most critical data and processes. Our team identifies key risk indicators, designs tailored monitoring plans, and provides continuous oversight to ensure the integrity of your trial data.
- Change Management: Developing and risk assessing change management plans tailored to specific needs, ensuring minimal disruption to your organization/trials.
DCT Advice
Decentralized Clinical Trials (DCTs) offer numerous benefits, including increased patient recruitment and retention, reduced costs, and improved data quality. However, they also present unique challenges. QARA provides expert advice on implementing DCTs, helping you navigate regulatory requirements, select appropriate technologies, and develop robust protocols.
- DCT Strategy: Advise on DCT elements and trial design.
- DCT Regulatory Assessment: Ensure compliance with national regulations.
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QARA Consultancy LTD. Registered in England and Wales. Registered Address: 86 Melling Road, Liverpool, L9 0LQ.
Company Registration No: 16188234. VAT Registration No: 485 3538 58.
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