With eCTD and eSubmissions here to stay, the choice of software solutions to help you comply with all the new requirements is becoming increasingly varied and confusing. At Datafarm, we offer you something unique and distinctive. We not only sell you our software and support services; but additionally, our experts from our Regulatory Services Group (RSG) are available to work in partnership with you to create the optimum solution for your own specific situation. As industry experts in regulatory submissions (both electronic and paper), Datafarm provides technical competency with industry recognized solutions, and extensive experience with large and small Life Sciences companies, partnering with our clients to achieve mutual success.
HOW WE CAN HELP
In addition to our software solutions for making eSubmissions easy, we offer three types of services to support regulatory submissions worldwide:
eSUB OUTSOURCING
Our experienced eSUB Outsourcing team have the skills and technology to transform your paper based submissions to a fully compliant eSubmission. Whether you need help transforming your legacy data for eSubmission or assistance in compiling your eSubmission our eSUB Outsourcing team is a very capable and efficient option.
Our eSUB Outsourcing services include, but are not limited to, the following:
- eCTD and regional guidance consultation
- eCTD and Publishing Training and educational services
- Scanning services
- PDF publishing
- Document & Submission quality control activities
- eCTD compilation
- Case Report Tabulation (CRT)
- eCTD XML backbone validation services
- SPL and PLR labeling conversion
- Gap analysis (Systems and Processes)
- Paper Dossier Services
- Submission preparation evaluation service
- Work Practices Kit
- eCTD checklist
You deliver your data and documents to us via CD or secured FTP and receive back a CD/DVD containing the completed electronic submission.
Ideal for clients who need to file electronic submissions but currently lack the infrastructure or resources to fully support the activity, outsourcing is also a good option for urgent requirements, such as filing an expedited or fast-track submission.
eSUB ENABLING
Driven by clients’ desire to develop the infrastructure and in-house capabilities necessary for submitting electronic submissions, eSUB enabling allows you to take advantage of our expertise, then lessen or eliminate your dependency on us when you are ready. As part of this collaboration, we provide the necessary resources to assist you in publishing and compiling the eCTD and, at the same time, provide expert on-the-job training.
- eCTD infrastructure development
- Software installation/validation
- end-user training
- collaboration on standard of operation procedures for
- authoring
- publishing
- legacy document conversion
- quality checking
- Knowledge transfer for best practices
- On-the-job training
Designed to support your strategic long-term goal of developing an in-house electronic document management system, eSUB enabling is ideal for company’s in the initial stages of implementing their electronic publishing strategy.
eSUB IN-SOURCING
Combining aspects of eSUB Outsourcing and eSUB Enabling, this approach supplements your resources with our own experts in a joint collaborative effort. The emphasis with this option is on achieving a compliant eSubmission, rather than focusing on knowledge transfer and, as such, does not offer “on-the-job-training.” However, we expect that your personnel will have gained an increased understanding of the eCTD electronic submission process by project completion.
Services in our eSUB in-sourcing option include, but are not limited to, the following:
- Augmentation of existing client resources
- Assigned activities supporting electronic submission project
- Consultation on technical and validation issues pertaining to electronic submissions
- Guidance and support for interpreting current ICH and Regional
- Specification and Guidance documents
eSUB in-sourcing provides you with the additional resources and expertise as and when you need them.
