Consulting Services for LCM, Medical Science, and RMP

With an innovative forward looking investment approach to the Risk Management Plan (RMP) on top of the standard regulatory and risk requirements, we can support you in creating value with complete life cycle management (LCM).
By selecting the best healthcare databases, providing optimized consulting services when required, and improving efficiency with the IRV, we will help you to achieve complete life cycle management.

Services

Signal management product: IRV ver2.0 with AZAREA-Cluster

  • In-house safety database (DB) compliant product package
  • JADER and FAERS are preset
  • Accessible to the data of the product preset JADER and FAERS. (The products in target areas are to be covered: Under construction )

e-RMP Update®

  • Access to all published RMP summaries
  • Search by drug name, drug class, and safety specification
  • Whether important risks of safety specifications are contained in the package insert can be seen at a glance

 

Click the icon below to visit the e-RMP Update website.

 

Provision of value-added data

  • Signal detection results for all adverse drug reactions (ADRs) by product and drug class
  • Case line listing for all products by disease and all ADRs by product
  • A transition of the number of cases using chronological data for ADRs and the total number of death cases by product, specific ADRs and SMQ by product
  • Comparison of the number of aggregated Adverse Events (AEs) (Comparison of drugs with same indications and AE trends using data stratified by age, gender, primary disease, and death)
  • RMP risk summaries: the number of signals and aggregated AEs by important risk

Benefits of implementing the IRV

  • An RMP tailored to your product strategy contributes to the LCM
  • Compliant with the revised GPSP: “LCM study” and “drug use-result survey” can be planned using real-world data
  • Effectively introduce signal detection and evaluation procedures required for periodic benefit/risk assessment report (PBRER)
  • Collect benefit-risk information and identify results of safety measures

Client’s needs and Croit’s solutions

Case 1: Utilizing real-world data as a monitoring tool

Client’s needs:

  • Comparison and study of benefit-risk information
  • Utilization of monitoring tool while keeping costs low

Our solutions

  • Suggest the use of a healthcare database as a monitoring tool
  • Apply use of healthcare databases that have been studied by academia

Results

  • Save time and costs while producing a good output

Case 2: Introducing a system to visualize important risks

Client’s needs:

  • Help with considering risk management for PBRER
  • Introduction of evaluation processes for statistical signal detection

Our solutions:

  • Provide specific strategies through our consultation to build up processes for signal detection and evaluation
  • Support implementation and efficient operation of the IRV

Results:

  • Early detection of trends and rapid response to risks of drugs with the same indications

Case 3: Utilizing patient monitoring by pharmacies

Client’s needs:

  • Ensuring that up-to-date information on proper use of the drugs is appropriately conveyed and understood by patients
  • Ensuring effectiveness of safety measures by minimizing risks
  • Consideration of best methods to minimize risks

Our solutions:

  • Suggest monitoring of all target patients by pharmacists
  • Support introduction of a system that uses process indicators in real time to understand safety measure effects

Results

  • Unnecessary updates of package inserts can be avoided by confirming patient awareness
  • Clinics can be provided with information for improvement of patient instruction

Summary of RMP

The RMP aims to ensure drug safety in the postmarketing phase by taking necessary safety measures based on the benefit-risk evaluations performed throughout the development, approval review, and postmarketing phases.
The RMP is developed by specifying the Safety Specifications with consideration to the Pharmacovigilance Plan and the Risk Minimization Plan.
When applying for new drug approval, the RMP is submitted to the Ministry of Health, Labour and Welfare and the PMDA.
The RMP should also be revised on a regular basis or as depending on the postmarketing situations; for example, if new safety concerns have been identified after marketing.

1. Create a new RMP Create an RMP that development and postmarketing departments can have a mutual understanding of
2. Develop an additional PV plan Develop an additional PV plan for important risks based on RMP and efficiently select appropriate tools
3. Develop an additional risk minimization plan Develop an additional risk minimizing plan for important risks based on RMP and evaluate the safety measure effects after executing the plan
4. Record and save the latest version of RMP Provide a system to post the latest RMP on your intranet site. Record and save revised RMP-oriented education for pharmacovigilance and safety implementation departments
5. Revise RMP periodically Utilize a visualization tool for regular assessment to reduce the workload at RMP-assessment milestones such as PBRER, PSUR, or DSUR
6. Prepare for emergency situations Establish a governance structure for emergency responses, such as corporate risk management by a rapid response team

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