Delivering Regulatory Compliant GxP Technology Solutions For Biopharma and MedTech
Techsol offers fully-managed GxP Technology platforms and related managed services for emerging Biopharma and Medical Device companies using the SaaS model. Clients can leverage our integrated system deployment models to manage business processes and GxP data to increase quality and operational efficiency.
Our System Integration Services
Increase Quality, Compliance and Productivity with our Powerful Safety System Integration Services
Establishing a streamlined Global Drug Safety and Signal Management system requires an integrated approach and a close-knit collaboration and communication between various functional groups. Pharma companies and Pharmacovigilance team members face a multitude of challenges with disconnected systems and manual processes to address key compliance challenges and operational oversight requirements.
With our technical and functional domain expertise in Drug Safety, we have successfully enabled clients to send safety case information such as adverse events and serious adverse events from external systems to Argus safety for case booking and electronic submissions to regulatory bodies.
Medical Information System and Argus Integration
Adverse Events reported by Healthcare Professionals (HCPs), Caregivers, and Consumers can be easily processed in Medical Information Systems like MedInquirer and transmitted electronically to Oracle Argus Safety.
With a bi-directional integration, the Medical Information team can automatically get acknowledgment receipts from Oracle Argus to MedInquirer.
How We Do it
- Complete Adverse Event E2B XML field mappings between MedInquirer and Argus Safety
- Define AE Transmission Rules based on one or more conditions
- Set the integration path using a E2B Gateway server or by using a SFTP folder setup
- Map the fields between both systems for receiving acknowledgements when the AE gets ‘Accepted’ or ‘Rejected’ in Argus
- Auto-populate the Argus Safety Case ID in MedInquirer
Oracle Argus and Inform Integration Services
Clinical Trial Sites can directly report Adverse Events to both the Data Management and Drug Safety Teams by establishing the Oracle Health Sciences InForm and Oracle Argus Safety integration. This helps to increase productivity and most importantly companies will never miss a deadline to timely report and process clinically significant adverse events.
How We Do it
- Identify the data points in Central Designer Logical Schemas that need to be sent to Argus Safety
- Define which data should trigger a follow-up to safety if the data is changed.
- Potentially related adverse events, labs, and concomitant medications are sent to safety based on time frames you configure.
- If desired, the Argus Case #, whether the safety user accepted or rejected the E2B file, and the rejection reason can be sent back to InForm.