Clinical data can be complex and overwhelming; Excelya’s expert data team can collect, process, store and communicate your data safely and accurately.
When you run a clinical trial, you produce data in huge volumes and at high speed throughout the process, so it is essential to manage that data effectively. You can maximize the value of your data by working with a clinical data management team that aims to collect, process, store and communicate that data safely and accurately.
With well managed trial data, you can make informed decisions, accelerate regulatory approval, meet compliance standards, and protect privacy.
At Excelya, we prioritize the integrity, quality and security of your data. Our dedicated global data management team of 100 clinical data experts have on average 10 years of hands-on data management experience. They are highly qualified, with Masters or PhD-level education, and are knowledgeable across therapeutic areas and phases. We have a team of specialists: Technical Data Managers, Clinical Data Managers, Clinical Programmers and Clinical Coders working under the oversight of a Lead Data Manager.
We act with transparency and honesty, and we are committed to doing what we say and staying accountable. Our data policies and processes are designed to avoid human errors, ensure privacy and security, and deliver high-quality work on time and on budget.
With a flexible approach and a dedicated team of data experts, Excelya can help increase your data quality and save you time.
Our data teams can build databases rapidly and efficiently using our 2 main EDC systems which allows us to decrease the number of edit checks needed to validate your study and clean the data fast. We use global libraries that we can customize for you to allow consistencies across your studies. This means use of repeat standards developed for you to meet your requirements.
We can help you across a broad range of data-related tasks.
– Design CRF based on your protocol
– Build your database selecting the best EDC for your study
– CDASH standards Excelya libraries or Sponsor libraries (help reducing cost and timelines)
– Data management team executes all activities during the study life cycle, from database setup to database lock using our tools and processes
– One Lead Data Manager assigned to a project with the support of a technical team and data management team
– External vendor data reconciliation using SAS listings
– RTSM integration
– Custom listings development in SAS
– Patient Profiles
Data science is evolving fast, and our clinical data experts have experience working with advanced technologies and the latest systems to get you the best results.
Our team works with market leader Veeva Vault as our default system – the only content management platform for managing content and data. With Veeva, we can accelerate the design and execution of high-quality trials, making it easier to manage even your most complex trials.
Excelya’s data teams can work seamlessly with your existing setup, as they have expertise in a range of systems and technologies, including:
• Oracle Clinical One
This enables our teams to design customized solutions that work for you.
DEDICATED GLOBAL DATA MANAGEMENT TEAM
100 knowledgeable Data Managers across our global offices
10 YEARS OF EXPERIENCE ON AVERAGE
A high level of task-related expertise, with up to 30 years of experience
EXCEPTIONALLY QUALIFIED TEAM MEMBERS
Our Data Managers have a Master/PhD level education and hands-on experience
HIGHLY KNOWLEDGEABLE STAFF
Experience in clinical studies across therapeutic areas and phases
Whatever your clinical data management needs, Excelya has a flexible option that can help you succeed. Our team’s approach always has the same high level of quality: We develop proprietary and innovative solutions to upgrade deliverables and strengthen communications.
With our international team, you can choose to work locally or scale up and run the project across onshore and offshore hubs globally. Our experts can close the gaps in your teams and capabilities through our flexible Resourcing model. And our data management support is available at three levels: Resourcing, FSP, and Full Service.
Excelya’s Functional Service Data Management model gives you access to our Operational Excellence Center and its team of qualified people, ready to go. We tap into our global network of experts to find you the right fit, and we can deliver work cost-effectively across on-shore, near shore and offshore data management hubs, enabling you to scale. Whatever you need, our people work seamlessly with yours: we can insert Excelya’s dedicated team into your quality workflow.
Our mission – to inspire excellence in everything we do – applies to our data management work. We work with you to agree on KPIs and target that drive performance management, and we go the extra mile. We set the standard, and we exceed it every time.
With our Full Service model, you can rely on Excelya’s expertise and proven processes to manage your clinical trial data journey end-to-end, from database setup to database lock. Our support includes eCRF design, database set up, query management, data review and validation, RTSM integration, external vendor database management and data reconciliation, SAS programming, Custom listings generation and patient Profiles.
Your project can benefit from the expertise of our Project Data Managers, Clinical Data Managers, Technical Data Managers, Clinical Coders and Clinical Programmers.