Frontier Science | Services
monitoring
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.
As a functional service provider, we can provide flexible support however and whenever you need it.
Our MONITORING Services & Approach
on site monitoring
We can provide regular visits to clinical sites to review regulatory documents, to complete source document verification (SDV) and to ensure adherence to the protocol
remote monitoring
We can also offer remote monitoring either stand alone or in conjunction with onsite monitoring using technology to conduct efficient and flexible monitoring without compromising on quality
risk-based monitoring
Tailored strategies focusing resources on high risk areas reducing the amount of source document verification required and to optimise study oversight
source document verification
Checking source documents against the case report form to ensure that the data collected meets all of the ALCOA++ standards and is of the highest quality
regulatory compliance checks
We can provide continuous review of essential documents including informed consent forms (ICF), ethics and MHRA approvals as well as delegation logs and full review of the Investigator Site File (ISF) and Pharmacy Site File (PSF) against the Trial Master File (TMF)
adverse events
We will monitor the reporting of Adverse Events (AEs) and Serious Adverse Events (SAEs) to ensure they are reported correctly and in a timely manner
investigational product accountability
A full review of pharmacy and accountability for the trial will be completed including monitoring storage conditions, the handling of the investigational product (IP) along with full accountability to maintain IP integrity
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Our MONITORING services include:
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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.
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
Quality
Devote your time to research knowing that all regulatory requirements are met, thanks to our quality systems.