Empowering Clinical Decisions with Outsourced Data Management and Biostatistics
Our clinical services are strategically designed to leverage the full potential of clinical data and statistics, ensuring medical devices not only meet but exceed regulatory and market expectations.
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By focusing on data-driven decisions, we provide a comprehensive approach to clinical trials, data analysis, and regulatory submissions, optimising the pathway from concept to market.
PLANNING
Strategic blueprinting of clinical trials to align with both regulatory mandates and market expectations, ensuring the collection of relevant and impactful data.
ANALYSIS
Utilisation of cutting-edge data analytics to derive meaningful insights from clinical data, guiding the development process and supporting evidence-based claims.
COMPLIANCE
Navigating through complex regulatory frameworks with expert precision, ensuring all clinical activities and data adhere to the latest standards and guidelines for seamless approval.
EFFICIENCY
Leveraging outsourced expertise and resources to streamline clinical development processes, optimising cost and time while maintaining flexibility and high quality in outcomes.
SUPPORT
BIOSTATISCAL
Once a clinical trial database is clean and locked, robust and correct statistical analysis is the next building block for study success. , our experienced team of programmers, data analysts and statisticians provide academic research, regulatory submission and consultancy support for studies of all shapes and sizes.
By tapping into our biostatistical expertise, you can be sure that the correct methods will be applied, resulting in accurate, interpretable results. We predominantly use SAS for our statistical analyses, but our team is also experienced in R and Stata.
SAMPLE SIZE
Ensure your clinical trial is valid by getting us to take care of your sample size / power calculations.
PROTOCOL DESIGN
Our experienced team can review, contribute to and review study protocols, ensuring that the right questions are being asked from the start.
STATISTICAL ANALYSIS PLANNING
Selecting the right statistical method is critical for your clinical trial. Thanks to the size and diversity of our team, we’ve been involved in a huge range of studies, so we can help you avoid common problems. We can create statistical analysis plans that meet your required specifications. This could include the details of calculations, layouts and dummy tables.
DATA MONITORING COMMITTEE
We have worked on both blinded and unblinded regulatory studies. If independence is what you need to give your trial additional gravitas and meet regulatory requirements.
CREATION OF CDIC DATASETS
We can create Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) datasets from specifications to CDISC standards, then develop study appropriate Tables, Figures and Listings (TFLs). As an FSP, we can provide all three of these services, or you can select individual ones to meet your unique requirements.
ANALYSES
Once an initial regulated study is completed and its associated data becomes available for other uses, we contribute to providing the data and assist with further analyses subject to the appropriate data application. We can also help support you with your own data and research question, whether that be within a trial, or perhaps an observational study.
SUPPORT
DATA MANAGEMENT
No matter the size, type or complexity of your clinical trial, high-quality data management leads to high-quality results. By partnering with us, 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.
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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.
DATABASE DESIGN
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.
DATA MANAGEMENT
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.
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.
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.
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 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.
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.
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