Clinical Trial Monitoring Services
EP Croit clinical research associates (CRAs) are almost all previous pharmaceutical company staff with drug development experience.
Our CRAs support implementation and utilization of a risk-based monitoring (RBM) approach which is flexible to meet your structure and needs.
By leveraging their experience, our CRAs can also provide comprehensive support across data management, analytical statistics, and quality control.
Are you facing any of these issues?
- You need CRAs with extensive experience.
- You need to complete clinical trials as planned.
- You need to implement multiple tracking systems.
- Our CRAs who are experienced in a related therapeutic area will be assigned to your project. These experienced CRAs then train and support less-experienced CRAs in their project team to cultivate their skills.
Our CRAs are knowledgeable in the latest therapeutic information and trends, and are involved in academic societies.
- Accelerate the patient enrollment process to meet enrollment timelines by utilizing our CRAs’ knowledge, and empirical methods.
Streamline all processes, from case entry to CRF retrieval, by collaborating with our data management department and/or implementing RBM.
- We have various tools and solutions to help improve project management and keep everyone on the same page:
- zenflow is a process management system developed specifically for pharmacovigilance processes, and is easily customizable according to your needs.
- “Agatha,” document management cloud service by Agatha Inc.
- “beagle medica,” eSource data system operation service by beagle CO., Ltd.
|Trial site activities||Work for investigational products||Client support||Risk-based monitoring (RBM)|
|Pre-trial||Appointment of investigator Site selection||Document archiving when necessary||RBM support|
|Clinical trial application|
|Clinical contract conclusion||Investigational product supply support|
|Start of trial||Start-up meeting (SUM)||Investigational product supply support|
|During the trial||Allocation/Patient enrollment|
|Reporting of adverse event (AE)/serious adverse event (SAE) and protocol deviations|
|Source data (document) verification (SDV)|
|SDV for essential documents|
|Quality control (QC) in monitoring|
|Case report form (CRF) retrieval/data cleaning||Retrieval of investigational products|
|Post-trial completion||Procedures for completion of the trial|
Clinical areas of expertise
- Infectious diseases
- Respiratory medicine
- Central nervous system
- Our support can be customized to suit your needs as our monitoring team can work with other service groups including data management, statistical analysis, and medical writing.
In addition, we can provide comprehensive package support from a drug development plan through to submission.
- We conduct our service in compliance with our quality management system (QMS), which has been refined through numerous iterations into a robust and efficient guideline.
- Our CRAs can be assigned individually or as a team to your project, so you do not need to spend time and energy to secure resources.
- We cover a wide variety of clinical trials including Phase I to V, postmarketing surveillance (PMS), and specified clinical trials.
- By providing next generation services for eSource, eConsent, RBM, mHealth, and RemoteSDV in collaboration with beagle CO., Ltd., we help reduce your SDV cost and improve your ability to collect high-quality clinical trial data to accelerate your new drug development.
Our extensive experience
|Phase||Phase１/２, ２, ２/３, ３（including investigator-initiated clinical trials), ４, and post marketing surveillance|
|Area||Autoimmune disease, renal disease, endocrinology and metabolism, transfusion/dialysis preparation, respiratory medicine, viral infectious disease, ischemic cardiac disease, ophthalmopathy, chronic pain disease, and oncology|
|Other services||Audits, GCP compliance inspection support, feasibility study, education and training, clinical trial consultation, Clinical Date Quality Management (CDQM), and submission of clinical trial notifications|
This graphic shows the plan, do, check, act (PDCA) process as implemented with RBM. Croit uses this process to continuously improve the quality of the clinical trial process.
PDCA cycle in RBM
- Risk assessment control
- Identify, analyze, and evaluate risks of a pivotal study.
- Establish mitigation strategies for identified risks.
- Monitoring plan
- Develop a monitoring plan including centralized monitoring based on risk assessment results.
- RBM training
- Conduct training for CRAs and personnel at all sites on the RBM approach.
- Centralized monitoring preparation
- Create a risk visualization template for risk evaluation with business intelligence (BI) tools such as TIBCO Spotfire.
- Centralized monitoring
- Monitor processes of each site based on a risk evaluation with the visualization template monthly.
- Use the results of the monitoring above for site monitoring as needed.
- Risk report
- Create a risk report describing processes predefined in a pivotal study and a summary on mitigation strategies for important deviations at the completion of a trial.
* These services can also be provided partially at your request.