Chiltern’s site engagement team takes care of the study startup, feasibility and site training responsibilities for you. Using the proprietary ePharmaOne™ platform offered by PharmaSolutions™, the team leverages its global locations and resources to identify sites, support vendor and site relationships, and manage local processes, regulations and record submissions. You choose the degree to which you need assistance and our team will optimize your trial for success.
Steps of Site Engagement
|Site Cascade Step||Objective|
|Initial Feasibility||Protocol review, experience (Chiltern and public domain data)
Contact Chiltern country-level leads and approach sites to determine preliminary strategy, initial interest and capabilities
|Detailed Feasibility||Approach interested sites and any identified sites to conduct an in-depth feasibility assessment|
|Shortlist of Sites||Agree in partnership to a shortlist of potential sites following a review of the feasibility results to determine the final site list for the site qualification visits|
|Qualification||Visit sites that are +20% above target to select the best sites to be initiated|
|Site Initiation||If the qualification visit is satisfactory, initiate sites and identify
reserve/back-up sites, if required
Study Startup Strategies
Where is the best place to run your clinical program? At Chiltern, our focus is on building strategic site relationships and partnerships that allow us to track and measure performance and select the right investigators, local country leads and key opinion leaders for your trial. Chiltern also leverages technology such as Citeline’s database of more than 370,000 investigators and the ePharmaSolutions™ proprietary ePharmaOne™ platform to target and obtain actionable intelligence from investigative sites. You can trust that you will have the best information to make an informed decision. Learn more below:
- Competing trials
- Ethics timelines
- Import/export concerns
- Electronic document exchange and signature
- Investigator motivation
- IP handling
- Patient availability/enrollment potential
- Protocol design
- Standard of care
The Right Decision Now
You need to know what is happening with your clinical program now. With Chiltern’s fully interactive Collaborative Technologies (CT) platform, you can. Whether you pick from our internal best-in-class solutions, your own in-house systems, a third-party offering or a combination of all three, Chiltern’s CT portal brings together all your trial data in real time. A genuine global understanding means you and your team can make informed decisions now — which is essential in today’s fast-paced global drug development environment.
Chiltern’s Collaborative Technologies platform includes:
INSIGHT CLINICAL TRIAL MANAGEMENT SYSTEM
Using a dedicated Internet-based study portal, Insight — our powerful clinical trial management system — makes data integrity central to every study. As data enters Insight, our global team of tenured data management personnel check for accuracy and ensure real-time review for appropriate clinical decisions. When the trial is complete, Chiltern’s statistical programmers and biostatisticians extract, analyze and interpret the most pertinent information and pass it along to our team of professional medical writers to summarize for presentation to regulatory agencies and the rest of the world.
Powered by TIBCO Spotfire®, our visual analytics tools enable us to present complex clinical information visually and in real time to identify hidden opportunities and risks. These advanced graphical tools give you a quicker grasp and greater insight into the meaning behind the numbers and allow you to make heads-up decisions every step of the way. We’ll help you implement tools for tracking and gaining insight into relationships between multiple variables in disparate data types such as clinical data, patient demographics, investigator site performance and patient outcomes. Chiltern’s visual analytics solutions will make key data, trend and event identification and exploration an advantage in your clinical program.
ELECTRONIC DATA CAPTURE
Implementing electronic data capture (EDC) technology can significantly reduce errors, improve quality and shorten timelines; however, selecting the right EDC tools is critical. On the leading edge of eClinical technologies, Chiltern has developed in-house expertise and also has formed strategic alliances with technology partners in order to provide a portfolio of comprehensive EDC solutions for you.
As the industry-leading solution for interactive response technology (IRT), endpoint® is streamlining IRT for clinical trials worldwide. The PULSE® platform is the fastest IRT to deploy for subject randomization, investigational product supply management and electronic patient reported outcomes (ePRO). Chiltern also works with a variety of other IRT providers, any of which can be plugged into the CT portal for seamless data reporting.