Technology Services
For more information on PPD's specific technology services, please choose an option from the drop-down box below.
Clinical Trial Safety Reporting
Oracle® AERS (Adverse Event Reporting System) is PPD's in-house repository for electronic adverse event and product complaint data. This validated 21 CFR Part 11 compliant system can be configured and scaled to meet current client's needs and future portfolio growth.
PPD has extensive experience supporting client-supplied adverse event management systems (including ARIS Global, ARGUS, Oracle AERS and Clintrace™), and we have worked on the deployment of these applications in many different client environments. PPD offers the following standalone or shared configurations:
- Safety events are captured in PPD's database where the client can view standard reports from PPD's Oracle AERS application or screenshots via a secure extranet, but not edit. PPD has the capability to export data in Oracle format, if desired. PPD will collaborate with clients on data transfer requirements and desired reporting formats.
- PPD can host a separate database for the client and can perform data entry and case processing. Clients may also log in, edit data and share workflow. PPD can also provide clients with secured functional access to Oracle AERS where safety data may be fully processed, extracted and analyzed from a client's remote location. This hosted environment requires the client to purchase named Oracle AERS seats directly from Oracle.
In summary, Oracle AERS provides:
- Global, Web-enabled database management
- Validated systems
- 21 CFR Part 11 and E2B compliant
- Robust reporting capabilities (MedWatch3500A; CIOMS-I, VAERS, ICH PSUR etc.)
- Trending and tracking capabilities
- Complete audit trails
- Controlled and secure access
- Device vigilance capabilities
- Hosting options for clients
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™
