At Chiltern, we understand that no two clinical trials are the same. That’s why we facilitate a collaborative approach to clinical trial design — you decide which technologies, processes and people are the right ones for your needs.

Connect Methodology

When you’re looking for program performance that meets your needs and delivers actionable results, Chiltern’s Connect Methodology has start-to-finish flexibility Designed Around You.

Chiltern’s Connect Methodology is a four-stage program designed to deliver a swift start and smooth finish to your clinical trial. Our team will ensure your study management and data collection solutions are working together seamlessly so you can focus on your trial outcomes.

When combined, Chiltern’s Connect Methodology and Collaborative Technologies build a complete solution that positions you to develop the most valuable data as quickly as possible.

1. Collaborate

  • Overview
  • Chiltern Focus
  • Sponsor Focus

Here, we set the stage for project kickoff with an induction plan — introduce you to the team and leverage their expertise to ensure your project is set up for success. Our feasibility manager will review your protocol and consult our proprietary databases, local country experts and key opinion leaders to provide you the best information to make informed decisions.

  • Define project scope
  • Propose strategic protocol
  • Design program
  • Assess feasibility
  • Identify risks
  • Outline operational strategy
  • Apply therapeutic expertise
  • Design protocol
  • Select service partners

2. Commence

  • Overview
  • Chiltern Focus
  • Sponsor Focus

This is your project’s kickoff. Our team meets with yours to detail roles and responsibilities, outline your program schedule and plan for site training and data collection. At this point, our team conducts an in-depth feasibility assessment on any interested and confirmed trial sites. The results are used to compile a shortlist of potential sites that we then use to determine the final site list for qualification visits.

  • Conduct kickoff meeting
  • Develop delivery plans and schedule
  • Define detailed feasibility/recruitment strategy
  • Develop monitoring strategy
  • Develop and implement data collections methods
  • Activate site selection and engagement
  • Initiate quality planning and assurance
  • Apply adaptive clinical trial design
  • Rapid Study Startup and first patient in
  • Regulatory and ethics approvals
  • Top performing sites

3. Conduct

  • Overview
  • Chiltern Focus
  • Sponsor Focus

This step gets your project underway. Our team begins with a quick startup process where satisfactory sites are identified through qualification visits, sites are initiated and activated, and patients are selected. Then, throughout your study, key leaders for each research site will deliver optimal site development practices and performance reporting.

  • Rapid patient recruitment
  • Manage program execution
  • Identify, monitor and control risks
  • Manage, monitor and oversee site quality
  • Monitor and manage data
  • Medical monitoring program
  • Manage project communications
  • Performance reporting
  • Active patient enrollment
  • Monitoring and data quality
  • Patient safety
  • Site relationships performance review

4. Conclude

  • Overview
  • Chiltern Focus
  • Sponsor Focus

Here, our team of data and analytics professionals deliver you the data you need to make decisions about moving your product forward to market.

  • Deliver biostatistics
  • Write reports
  • Risk monitor and control
  • Close sites
  • Quality management and control
  • Performance reporting
  • Deliver trial master file
  • Quality, submission-ready data
  • Clinical trial results

Collaborative Technologies

When you need automation and analytical tools to visualize data and make decisions, Chiltern has modular study and data collection technologies Designed Around You.

When combined with Chiltern’s Connect Methodology, these technologies build a complete solution that positions you to develop the most valuable data as quickly as possible.

The Right Sites

When choosing investigator sites, it is invaluable to know their performance results on other trials — particularly those with the same sponsor and CRO and in the same indication. We select the right sites by combining your preferences for key investigators with information from past Chiltern studies and historical activities across all clinical studies.

The Right Direction

Understanding the status of any part of your study execution is critical, but having leading indicators and trend analysis is essential to proactively address issues and manage a risk-based trial environment. Study dashboards provide a comprehensive view of site startup and performance, bringing together clinical and operational data to understand exactly what is happening on your study now.

The Right Decisions

Part of our responsibility to you is to keep your study on budget. We use a suite of tools to continually monitor the costs of our services as well as those of vendors, investigators and third parties.

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.