Frontier Science | Services
Quality
QUALITY ASSURED
When you’re running clinical trials, quality matters. Regulatory standards demand ever-increasing levels of transparency and compliance, which is why we treat quality assurance (QA), quality management systems (QMS) and technical writing as specialist services alongside our data management and biostatistics expertise.
Prioritising quality during a clinical trial ensures patient protection and high-quality data at the point of analysis, so every stakeholder in your study can have the utmost confidence in the results. So, whether you’re looking for regulatory compliance consultancy, a fully managed QMS – or just about anything else related to the quality of clinical trials – our expert team can help.
As a functional service provider, we can provide flexible support however and whenever you need it.
Our Quality Services & Approach
REGULATORY & STANDARDS COMPLIANCE
The list of requirements that studies have to meet can be long and complex. We’ll look at the whole picture, including factors such as regulatory compliance, Good Clinical Practice (GCP) and other ICH standards, as well as any other specific requirements attached to your study like standard operating procedures (SOPs) or the protocol.
BUILDING & IMPROVING A CLINICAL QUALITY MANAGEMENT SYSTEM
To meet Good Clinical Practice (GCP) standards, you need a fully compliant QMS – no matter how big or small your organisation is. An effective QMS will go further than simply meeting these regulations, helping to support your staff and study activity and leading to positive audit and inspection outcomes.
CLINICAL DOCUMENT WRITING SERVICES
When it comes to the documentation for clinical trials, we breathe the industry mantra : If it’s not written down, it didn’t happen. For our customers, this approach translates as clear, well-written documentation which ensures all trial aspects can be reconstructed and that you’re always audit and inspection ready.
QA study support & trial master file services
We understand how important it is to have an accurate and thorough Trial Master File (TMF) that makes it easy to evaluate the study conduct and data quality, and for this to be created in line with the study plan.
CLINICAL MONITORING
FSS can help you establish a well-defined quality control (QC) monitoring programme with proper oversight. Our team can provide remote and onsite monitoring for quality control of your study, ensuring that it consistently complies with the protocol, SOPs, GCP and relevant regulatory requirements. Our monitors can work both with our in-house procedures and with partner or client monitoring procedures: we can be flexible depending on your needs.
REGULATORY & STANDARDS COMPLIANCE
We work both remotely and onsite, carrying out independent quality checks and issue detection to help identify areas for improvement and if non-conformances are discovered, we can facilitate their correction.
Our compliance services include:
Audits – vendor qualification, computer system validation, systems & internal processes, study site files, trial master files, and clinical trial documentation
Regulatory, Standards or QMS Gap Analysis
Corrective & Preventative Actions (CAPA) Remediation
Audit & Inspection
Readiness Consultancy & Support
BUILDING & IMPROVING A CLINICAL QUALITY MANAGEMENT SYSTEM
Setting up a QMS from scratch
If you’re new to quality management systems, we can help you set up a GCP-compliant QMS that designs quality into your working practices and focuses on the prevention of issues. Getting it right first time will reduce the likelihood of costly correction work. At FSS we have particular experience in building effective QMS for small organisations. We’re also able to apply the best Quality Management, DM and Biostatistics practices we’ve accumulated over two decades of clinical trial experience to non-regulatory academic studies.
If you already have an existing quality management system
We can help improve processes, practices, and standards for clients with established quality management systems. Our team can also guide you through a move from a paper-based to an electronic system, and help you bring the right quality skills in-house if required.
Systems validation
If you’re using computer systems to handle trial data or records, it’s your responsibility to ensure the system you choose or build is validated and fit for purpose. Validating a system can be a resource- and documentation-heavy activity. At FSS we’re experienced in validating systems, from data collection to statistical analysis and reporting.
CLINICAL DOCUMENT WRITING SERVICES
FSS technical writers work closely with study statisticians, programmers and data managers to create high-quality clinical trial documentation for different trials and therapeutic areas. We keep abreast of all relevant regulatory standards and best practice guidelines, and are flexible enough to adapt to partner or client templates and procedures.
Our technical writing services include:
- SOPs covering all aspects of the conduct, analysis and reporting of clinical trials
- Study protocols and amendments
- Statistical Analysis Plans (SAPs), Statistical Programming and Data Management Plans
- Quality, Trial Master File, risk management, vendor oversight and Monitoring Plans
- Conference materials – abstracts, posters and slide sets
- Manuscripts
- Computer systems validation documentation – plans, requirements, test scripts, reports
- QMS policies and procedures
- Site newsletters
- Training materials
- Editorial support.
QA STUDY SUPPORT & TRIAL MASTER FILE SERVICES
At Frontier Science Scotland, our quality team includes our technical writers who manage the TMF: if you work with us, you’re guaranteed an integrated Quality Assurance and Trial Master File service. This ensures that your study will comply with Good Clinical Practice but also Good Documentation Practices.
Our Trial Master File & QA study support services include:
- QA consultancy on study specific training, risk management, study documentation review and study build validation
- Trial Master File set up, regular review, maintenance, archival and transfer
- A QA, technical writing and Trial Master File integrated resource to work alongside data management and/or statistical centre teams
- QA and Trial Master File introduction and refresher training.
WHY SELECT FSS FOR QUALITY?
Our expertise
We have a commitment to quality and a dedicated team of QA and technical writing professionals who specialise in Good Clinical Practice data handling.
Our integrated approach
Our quality staff form an integral part of a study team. We get to know the study in-depth right from the start so that we can guide on the right approach, troubleshoot in advance and intervene early
Our knowledge
We maintain up-to-date knowledge of relevant regulatory standard requirements and best practices and are always prepared for upcoming changes.
Other services
Data Management
Speed up your route to a clean and accurate clinical research database by tapping into our expertise.
Biostatistics
Let us transform the data collected in your clinical research and trials into meaningful reporting and analyses using our CDISC-compliant systems
Let's work together
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