Med Info and Safety Departments operate in silos resulting in redundant process, duplicate effort and hence compliance challenges. Following are the few challenges and impacts identified due to the siloed process:
- Non-validated intake: Receiving AEs via email clients is not ideal. This leads to higher risk of losing an email due to spam filters or human error
- Manual entry: Information received via email is manually transcribed into the system resulting in increased labor cost and human error
- Emailed AE report: AE reports are sent as Word or PDF documents to the safety department via email. Email systems are not validated, no audit trail or data integrity
- Double data entry: The safety department must manually enter the data into Argus resulting in increased labor cost and human error
- Manual reconciliation & active monitoring: Receipt of adverse events must be manually sent from PV and then manually recorded by MI
Techsol offers an integrated Oracle Argus Drug Safety and MedInquirer Cloud solution for pharma companies to manage both Drug Safety and Medical Communications business operations efficiently in a smooth regulatory compliant manner.
Incoming Inquiries via phone, email or other channels like CRM, web forms can be captured in MedInquirer (SCIMAX MI) and AE data can be transmitted to our integrated Argus Safety database (AccelSafety) via fully validated E2B adaptor. This enables automation of data transmission and reduces the manual efforts, eliminates duplicate entry.
Techsol’s integrated solution is bi-directional, transmitting the data and reconciling the Safety ID and status generated in the Argus Safety System (AccelSafety). E2B import process also generates an acknowledgement file which is sent to MedInquirer (SCIMAX MI) and it is auto imported. MedInquirer also has the feature to generate system alerts feature which sends alerts if acknowledgement is not received within specified time frame.
Key Benefits for Clients
- Compliance/ Process
- Faster, higher quality responses
- Reduced compliance risk
- Cost savings
- Reduced overhead entry and QC
- More savings/margins
- Less manual entry for intake and safety
- Drastic reduction in an effort
- Fewer transcription errors
- Better data integrity