Medical Science Services for Real World Data Study
Real-world databases (RWDs) with up to tens of millions of records have been successfully leveraged for research to ensure pharmaceutical drug safety in the US and Europe.
With experience in RWDs since 2015, EP Croit provides customers with total support services for RWDs, from training and protocol development through to writing and submission of papers.
Having problems with postmarketing DB studies?
- Where do I begin?
- Want to find best practices by benefiting from knowledge gained from external sources.
- Need external support for implementation of a validation study and selection of an electronic healthcare DB.
Croit can solve all these problems!
- Provide comprehensive support from planning through to the PMDA application.
- Deliver training for your staff.
- Offer know-how gained from our DB studies and collaborative studies with academia.
- Propose optimal algorithms to define outcomes and definitions of exposure by leveraging our assets accumulated through conference presentations.
- Company A: Preparation for electronic healthcare DB studies, protocol development, advice from academia, preparation for reports, writing and submission of papers
- Company B: Implementation of statistical analysis based on the client’s protocol (Preparation of statistical analysis forms)
- Company C: Holding of workshops, preparation prior to an application, protocol development, response to queries from PMDA in postmarketing DB studies
- Company D: Training for the Company D’s staff members so that they can take the lead in the postmarketing DB studies
We will customize our support service based on your needs and requirements.
|Support for the use of MID-NET||Data collection from the MID-NET Onsite Center|
|Outcome validation study||Support for development and implementation of a validation plan of outcome definitions, and preparation of the report|
|Response to protocol queries from PMDA||Support from document submission to face-to-face advice at an epidemiological study consultation|
|Advice from academia||Support for process to gain advice for a protocol from academia|
We extensively support your electronic healthcare DB utilization with our special team and experience as follows.
- Setting up of electronic healthcare DB team
- Persons responsible for GPSP and GVP
- Consultant team for protocol development
- Team conducting analysis based on pharmacoepidemiological studies
- Collaboration with DB vendors
- Collection of information in real time
- Collaboration with academia
- Collaborative study with academia specialized in pharmacoepidemiology
- Appointment of academia coordinator
- Development of IT infrastructure
- Handling of bulk data
- Consulting services
- Consultation experiences in postmarketing DB studies
- Support for response to PMDA queries at an epidemiological study consultation
- Holding of workshops
- Staff training for postmarketing DB studies
- Provision of seminars or lectures on pharmacoepidemiology
- Experienced in defining outcomes
- Revising algorithms of the outcomes defined previously
- Made an academic conference presentation for outcome validations
Experience (as of Feburary,2019)
Electronic healthcare DB studies
- Number of clients: 12
- Number of research questions : 80
- Database: Medical Data Vision (MDV), Japan Medical Data Center (JMDC)
- Areas: malignancy, diabetes mellitus, hypertension, thromboembolism, liver injury, ocular disorders, central nervous system, and respiratory system
Academic conference presentations
Presentations at Japanese Society for Pharmacoepidemiology
- 7 presentations from 2014 to 2017
- 2 presentations as below in 2018
- – A cohort study for evaluating efficacy of diabetes drugs for cardiovascular disease by using MDV database
- – An outcome validation study with laboratory values as the Gold Standard
Writing and submission of papers
- Total number of papers : 31 (29 in English)
- Areas: malignancy, nervous system, urinary system, diabetes mellitus (in descending order of experience)
e.g. Assessment of bleeding in patients with disseminated intravascular coagulation after receiving surgery and recombinant human soluble thrombomodulin: A cohort study using a database (https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0205146)