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Development Outsource

Comprehensive Data Management and Biostatistical Analysis

CLINICAL 

SUPPORT

At the forefront of clinical innovation, our services are designed to streamline and enhance the clinical trial process for biotech and pharmaceutical companies of all sizes.

 

We understand the critical importance of precise clinical data management and sophisticated biostatistical analysis in bringing new therapies to market. Our team of experts combines deep industry knowledge with cutting-edge technology to offer a full suite of services tailored to meet the unique needs of each trial.

OUR

PARTNERS

Clinical Outsourced medical device partners

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.

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.

CHAT

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