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.

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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