Frontier Science | Services
Data Management
DATA MANAGEMENT FOR CLINICAL TRIALS
No matter the size, type or complexity of your clinical trial, high-quality data management leads to high-quality results. By partnering with FSS, you’ll benefit from advanced data management systems, consistent reporting and a focus on meeting database lock deadlines. With increased demand for study sponsors to improve data management standards and meet regulatory requirements, we’ll work with you to provide solutions for your clinical trials.
Our data management team, made up of data managers, project managers and database programmers, has decades of combined experience. This means you can rely on us to deliver clean, accurate, complete and reliable datasets for analysis, every time.
FUNCTIONAL SERVICE PROVISION (FSP) FOR DATA MANAGEMENT
As a functional service provider, we can supply data management services that fit seamlessly with other partners of a clinical study and your own in-house expertise. So whether you need support with database design, documentation or data cleaning – or all of these and more – you’ll find our team of experts to be responsive and friendly to work alongside. We will collaborate closely with all members of your extended team and tailor our services to your needs.
OUR DATA MANAGEMENT SERVICES & APPROACH
CASE REPORT FORM (CRF) DESIGN & ANNOTATION
We bring the aims and deliverables of your trial to the forefront when designing Case Report Forms (CRFs), implementing data capture systems to suit. As data management becomes more automated and data intensive, we’re adapting our processes to match so that hybrid/decentralised data collection becomes a reality for our customers and clinical trial participants.
DATA CLEANING
We use a combination of programmed system edit checks and manual data cleaning processes to ensure data is as clean and accurate as it can be. As part of this process, we provide medical coding services where required.
DATA MANAGEMENT DOCUMENTATION
We can consult on or manage the documentation required for successful clinical trial data management, creating regulatory-standard records on the context, methodology, file structure, quality assurance, manipulations and more.
DATABASE DESIGN
Our experienced team builds bespoke databases for every study we work on, so you can be sure a database created by FSS will meet the exact needs of your clinical trial. We provide reliable integration of the clinical trial database and third-party data to form complete datasets and can create Electronic Data Capturing (EDC) systems.
REPORTING
Stay informed and get access to early insights thanks to our reporting systems. We understand the importance of sticking to timelines and building towards database lock at critical points during the study.
CDISC DATA EXTRACTION
We adhere to clinical data interchange standards conventions (CDISC) for data collection, organisation and analysis to ensure that we always deliver high-quality data.
DATA VALIDATION & INTEGRITY
We’re able to oversee entry and validation at the clinical trial sites, and we can also design randomisation specifications to ensure confidence in the results and conclusions of your clinical trials. We strictly adhere to Good Clinical Practice (GCP) and our own quality validation and discrepancy management processes.
PRE-ANALYSIS DATABASE LOCK PROCEDURES
Once we have been given a database lock date, we work backwards to ensure that all the necessary processes are scheduled. If you work with us, you can be confident your database will be handed over complete and clean.
PROTOCOL DEVELOPMENT
We can contribute to protocol development and amendments, using our expertise to guide good decision making and protect the integrity of the clinical trial.
Why select fss for your data management?
Flexibility
Rather than using an off-the-shelf, standardised approach to data management, at FSS we’re more flexible. This lets you run your study the way you want to, safe in the knowledge that our team will help you foresee and avoid potential future complications.
An unrivalled history in data management
Our founder, Eleanor McFadden, literally wrote the book on the Management of Data in Clinical Trials, which is used in academic and commercial settings around the world. The Frontier Science Scotland data management team has benefited immensely from Eleanor’s 40+ years of working in the field, and we’re able to pass this unique knowledge on to our customers.
We’re both academic & commercial
Our customers appreciate our ability to translate the requirements of both sides when we’re involved in a clinical trial that involves partners from both academia and the pharmaceutical industry. Our team generates solutions that meet all regulatory and reporting requirements.
We work worldwide
While we predominantly work to standards developed by the European Medicines Agency (EMA), we’ve got experience in working with data from across the globe, including the United States, China and Japan.
“Frontier Science Scotland is amazing to work with. Always professional, supportive and timely in service and support. An amazing team of people. Dedicated, professional and eager to find solutions”
Other services
Quality
Devote your time to research knowing that all regulatory requirements are met, thanks to our quality systems.
Biostatistics
Let us transform the data collected in your clinical research and trials into meaningful reporting and analyses using our CDISC-compliant systems
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