Traditional systems for managing clinical trials are giving way to the new paradigm of risk-based monitoring (RBM). Now accepted by both the European Medicines Agency and the U.S. Food and Drug Administration, RBM is intended to improve efficiencies and shorten studies by analyzing and reacting to data as it is acquired throughout the trial.

Chiltern helps you stay in control of complex trials by identifying your biggest risks and building a program that analyzes and responds to information and data you collect in near real time. Our clinical development team uses advanced visual analytics tools — powered by TIBCO Spotfire® — and proven processes to first identify and assess, then circumvent risks, keeping your patients safe and your study under control.

Stay in Control

Maintaining participant safety, site consistency and data quality are some of the most important responsibilities of clinical trials. RBM studies must adapt quickly to minimize risk and maximize safety — a task that has become a challenge to manage as study numbers and complexity grows.

Choosing an RBM trial design requires more intensive trial oversight and attention to FDA regulations, but it can shorten study time frames and decrease research and development costs.

Chiltern develops the right RBM strategy for your trial’s needs based on:

  • Your choice of electronic data capture and other systems
  • A monitoring communication plan with continuous review and modification requirements
  • A clear understanding of RBM roles and responsibilities
  • Continuous risk assessment via critical variables, safety trends, site performance and the employment of data standards for trial optimization

Identify, Assess and Circumvent Risks

Chiltern’s clinical development team uses advanced visual analytics and proven processes to first identify and assess, then circumvent common risks, keeping your patients safe and your study under control.

We understand that for RBM to accomplish its goals, the protocol design, the communication and coordination of study data, the analysis and the decision making must be planned and meticulously executed as the study progresses. Rather than forcing project teams to rely on data from static reports, we enable a continuous flow of study and site data as well as smart, automated workflows and audit trails to reduce risk and improve compliance and overall trial quality.

Risk Assessment

To ensure complete risk assessment, Chiltern uses a risk assessment categorization tool (RACT) to identify study-level risk and establish a risk mitigation plan. Additionally, Chiltern develops an integrated quality risk management plan (IQRMP) to align cross-functional quality management plans across identified risks.  A three-step process, with specific checkpoints for review, ensures your plans meet the specific needs of your study.

Initial Data Review

Checkpoint 1:
Data review by centralized teams

  • Compliance
  • Operational indicators
  • Quality
  • Subject-level iterative review cycles
  • Safety
  • Tailored review of central data points defined in IQRMP

Medical Review

Checkpoint 2:
Data review by specialized medical review team

  • Comprehend
  • Inter/intra subject and site review for medical consistency and patient safety
  • J-Review
  • Spotfire
  • Targeted monitoring and visualization tools
  • Targeted source data verification (SDV)

Deep-Dive Medical Review

Checkpoint 3:
Medical review allows for oversight of protocol and indication-specific variables by physician and biostatistician experienced in that therapeutic area using:

  • Ad hoc SAS output list
  • Data visualization tools

Chiltern’s Quality by Design (QbD) approach to RBM utilizes a systematic risk-based quality methodology to focus on risks to the most critical data elements and processes. Chiltern concentrates on key issues such as data verification and source data review by qualified medical personnel as well as on patient and other performance statistics from investigative sites. By capturing, analyzing and acting on this information, Chiltern will collaborate with you to fine-tune studies for greater efficiency, possibly eliminating the need for some data or even entire trials.

Put together a seamless, dynamic and innovative trial using Chiltern’s RBM process and services.

RBM Process

  • Build an SDV plan
  • Assign subjects
  • Perform and track SDV
  • Review site quality
  • Adjust SDV plan

RBM Services

  • Program and protocol design
  • Clinical monitoring
  • Medical monitoring
  • Remote monitoring
  • Data and analysis
  • Pharmacovigilance
  • Regulatory services
  • Quality assurance