CDISC Electronic Submission Support Services
CDISC standards implementation support
The “CDISC¹ standards” are the global standard for the exchange of clinical study data.
FDA² already requires electronic submission and PMDA³ will require submissions to be based on CDISC standards from April 1st, 2020 ending the transitional phase of electronic submission of clinical study data.
EP Croit provides one-stop support services for submissions to both PMDA and to FDA.
1. CDISC: Clinical Data Interchange Standards Consortium
2. FDA: Food and Drug Administration
3. PMDA: Pharmaceuticals and Medical Devices Agency
There could be many motivators which might require you to implement CDISC standards:
- To share clinical data with external parties such as partner companies and overseas affiliates
- To standardize internal clinical data
- To integrate existing clinical study data with new data
- To submit data to PMDA or FDA
EP Croit has gained extensive experience in clinical trials since we started offering contracted businesses for CDISC services in 2005. We provide flexible support for CDISC standards implementation to meet your needs.
EP Croit has been a CDISC corporate member since the beginning of its CDISC activities in Japan. We are also a board member of the Japanese CDISC Coordinating Committee (J3C) and participate in activities of the CDISC Japan User Group (CJUG) *.
Over 100 employees have received official CDISC training, which is a very significant number of attendees in the industry. In addition, over 300 employees have received internal CDISC basic training and over 100 employees have received advanced training to deepen their understanding of CDISC standards.
We leverage the expertise and knowledge gained through training and CJUG activities to propose optimal CDISC standards implementation methods to you.
*Registered members of CJUG by category: 2 CDASH members / 6 SDTM members / 1 ADaM member / 3 SEND members / 4 SDS members.
(As of October 2017)
|CDISC basic training||We can organize a workshop for your team covering topics such as CDISC basic concepts, regulatory requirements, as well as covering implementation noteworthy points and procedures.|
|Analysis||With a customer’s current status of submission data, and processes to conduct analysis for CDISC standards implementation, we are able to help you define agendas and prioritize tasks to be addressed.|
|CDISC standards-compliant work processes||We can help you establish work processes required for CDISC standards implementation.|
|Support for your electronic data submission||We support you with electronic data submission by assisting with preparation of “Appendix 8” and attending the consultation for electronic data submission plan with you.|
|CDISC-related submission document verification||We verify whether CDISC-related submission documents created by other vendors satisfy the latest regulatory requirements.|
Verification of agenda in CDISC standards implementation
Company A had the following two major agendas for CDISC standards implementation to be verified in advance.
- To conduct verification based on CDISC standard implementation
- Full processes implementation: CDASH -> SDTM -> ADaM -> tables, listings, and figures (TLFs)
EP Croit’s solutions
- Proposed regulations and rules for creating SDTM and ADaM datasets
- Standard program design that ensures consistency between various specifications and programs
- Creation of verification records using traceability methods
To alleviate any concerns regarding CDISC standards implementation, we ensured that Company A was informed of any necessary work processes in advance.By pre-verification of the agendas mentioned above, Company A was able to avoid potential problems during the actual implementation.
* In the case of ongoing study
Data Creation Service
EP Croit offers CDISC standard dataset creation and consulting services such as creation of SDTM and ADaM data in order to respond to specific for CDISC standards requirements.
|Items to be created||Description|
|SDTM datasets||We create SDTM datasets based on the DM data of both legacy and ongoing studies.|
|ADaM datasets||We create ADaM datasets implemented from SDTM datasets. We can also provide you with a program to use in-house if required.|
|Define-XML||We create Define-XML for SDTM and ADaM. We can also create Analysis Results Metadata if required.|
|CDISC-related documentations||We create Annotated CRFs, Study Data Reviewer’s Guides, and Analysis Data Reviewer’s Guides.|
|Statistical analyses-related tasks||We support a broad set of work processes from creating CDISC datasets, setting necessary internal rules, conducting PMDA or FDA application, and creating analysis plans and reports.|
Experiences in dataset creation
Datasets we created have been used for actual electronic submissions. We also have experience attending consultations for electronic data submissions.
- Number of contracted studies：Approx. 120
- Extensive experience in phases I to IV and postmarketing surveillance
- Number of contracted studies: Approx. 50
- Extensive experience in phases I to IV
Examples of areas we have the most experience in
- Cardiology, gastroenterology, ophthalmology, dermatology, endocrine (urology), oncology, psychiatry
We create datasets through consultations with you and incorporating your requirements. The following is a typical process for creating SDTM/ADaM datasets.
Verification of CDISC datasets created by customers
- Verification of PMDA Regulatory Compliance for data being submitted to FDA
- Verification of electronic study data created by partner companies
- Consistency verification of a package just prior to submission
Development of tools to increase efficiency
- Define.xml creation macros with use of customer’s own templates if available
- PK dataset creation tool, which can create everything from PP domains to analysis reports in one go
EDC Study building support
For more efficient DM operations, we can provide support for everything from building the EDC Study in CDASH format through to CDISC dataset creation. Our varied services including CSV support, report preparation, and system linkage are also available to help you achieve your business goals.
Assessment and consultation for eCTD application
If you have concerns about CTD/eCTD submissions such as Word or PDF issues, validation of the eCTD compilation system or the next generation of eCTDs, please feel free to consult with us regardless of study or project size. Our experienced staff will conduct an assessment of your current situation and propose practical solutions.
Assessment and consultation for CDISC/eCTD
If you are concerned about CDISC/eCTD becoming mandatory in the near future, we can assist you with building the necessary foundation, including SOPs, systems, and resources. Our experienced staff are familiar with these systems and specifications and will conduct consultation to match your specific requirements.