Technology Services
For more information on PPD's specific technology services, please choose an option from the drop-down box below.
Clinical Trial Electronic Submissions
We realize how important it is that your clinical trial electronic submission documents are timely, accurate and aligned with FDA requirements. Our trained staff has extensive experience working with the FDA on all types of clinical trials, enabling us to quickly and collaboratively work with clients to assess, critique, compile and electronically submit your clinical trial documentation to the FDA.
We use our expertise in SAS
software to create custom FDA-compliant data definition tables and electronic case report tabulation (eCRT) documents, enabling our data to seamlessly integrate with our clients' specific data warehousing applications. We also ease the review for the FDA by incorporating cross-document references such as hyperlinks, bookmarks and indexing.
Our experience and expertise with preparing electronic submissions for clinical trials includes:
- Working across multiple protocols to integrate data into CDISC SDTM and eSUB format
- Standardizing and integrating data in different formats from different sources
- Producing eSUB deliverables with the FDA reviewer in mind
- Responding quickly to ad hoc requests and changing requirements
- Utilizing quality control processes to ensure accurate and FDA-aligned documentation
- Understanding and utilizing the functionality of automated tools to streamline document and data preparation and submission
Electronic Data Capture (EDC) | Clinical Trial Electronic Submissions |
IVR and IWR Systems | IVR and IWR System Services |
Adverse Event Adjudication | Clinical Trial Software Consulting |
Clinical Trial Software Products | Clinical Trial Safety Reporting |
Client Portals - PPD DirectConnect™
