The way you establish, collect, manage, interpret and prepare clinical trial data for submission can be the difference between a successful trial and an expensive failure. Chiltern’s industry-leading team of data management professionals and statisticians is one of the largest in the industry. With real-world experience in adaptive trial designs and the latest data analytics platforms and technologies, we make certain you can not only access, but also examine data at an individual patient level.
Using Insight — our powerful clinical trial management system — you gain access to a real-time snapshot of your trial status at any time When your trial is complete, Chiltern’s team extracts, analyzes and interprets your data, then prepares it for presentation to regulatory agencies and the rest of the world. At the end of the day, our job is to help ensure your entire project team is able to conduct compliant, cost-effective trials. We focus on the intricate details of your study so you can focus on your trial and on providing new therapies to patients around the world.
Data & Analysis Services
The Right Data
Predictable, quality trial results are essential to advance your clinical program to the next level or “fail fast.” By combining data from across all applications where clinical data is collected, we’re able to provide detailed patient profiles and customizable visual analytics to see the specific data and subsets in the exact format necessary to inform decision making during and after any trial or program.
Throughout your study, Chiltern ensures your success with these technologies and services:
Biostatistics and statistical programming
Chiltern’s biostatistics and statistical programming team provides operational and strategic statistics for clinical research and development. Our operational expertise allows us to deliver the high-quality statistical output required for every aspect of drug development including the statistical material you need for study reports and for regulatory responses.
CDISC consulting solutions
Since our first Clinical Data Interchange Standards Consortium (CDISC) compliant submission in 2004, Chiltern has been at the forefront of CDISC compliance requirements. In the last 12 years, the Data & Analysis team has gathered extensive experience in all areas of implementation — building more than 60,000 domains.
Clinical data management, data technologies and programming
Our proficiency in the industry’s top technology solutions allows us to recommend and apply these systems to maximize your process efficiencies, timeline management and cost minimization. The truth is, there is no “best” electronic data capture (EDC) provider — but there is the right provider for your company or trial, and we can guide you to the right one.
- MedNet, iMedNet™
- Merge eClinicalOS®
- Oracle® InForm
- Perceptive DataLabs®
Medidata Rave® Value Accelerators
Chiltern’s Medidata Rave Value Accelerators Suite is an advanced and robust system for capturing, managing and reporting clinical research data in Phase I–IV studies. Within this system are three accelerator tools:
- Chiltern Rave EC Reviewer
- Chiltern Rave EC Detector
- Chiltern Rave EC Analyzer
These tools streamline the clinical trial process and help you optimize your R&D investments, save a considerable amount of time, minimize your team’s manual efforts and maximize the quality of your deliverables. The technologies can be configured to any trial — from simple to complex— and are flexible, scalable and accessible anytime, anywhere.
Chiltern Cloud Analytics Passport – Powered by SAS®
Chiltern’s Cloud Analytics Passport — Powered by SAS is a clinical and biostatistics reporting environment that enables you to leverage Chiltern’s established data solutions and infrastructure while providing a gateway to additional SAS products. Save money on IT costs, gain access to more advanced analytical tools and Chiltern’s experienced data team, while you get up and running faster with space on a SAS grid environment.
- Software as a Service (SaaS):
Create the solution you need with access to SAS software and the SAS Grid including SAS Visual Analytics
- Platform as a Service (PaaS):
Build and customize your grid to fit your needs with secure access to one authoritative data source by both sponsor and development partners
Enable self-service analytics and eliminate data hand-offs and inefficient processes for studies anywhere with licensing that works across the globe
Visual analytics and reporting
Chiltern has developed visual analytics tools and techniques that allow us to present your complex clinical information visually to identify buried opportunities and risks so you can make informed decisions in real time.
These techniques give you a quicker grasp and greater insight into the meaning the numbers actually represent. Through our innovative and collaborative approach, we enable you to focus on what is really important: better trial outcomes for your patients.
IDMC/DSMB and CEC management
Safety surveillance and predictive signal detection
- Data warehousing