{"id":23349,"date":"2021-06-26T11:34:06","date_gmt":"2021-06-26T11:34:06","guid":{"rendered":"https:\/\/ultragenicglobal.com\/?page_id=23349"},"modified":"2023-09-11T08:07:49","modified_gmt":"2023-09-11T08:07:49","slug":"ultrareg","status":"publish","type":"page","link":"https:\/\/www.fyeo.in\/ultragenic\/ultrareg\/","title":{"rendered":"UltraREG"},"content":{"rendered":"
<\/div>
UltraREG<\/span>

UltraREG is Ultragenic’s proprietary solution that automates data entry and reporting in local languages, fulfilling the Local Health Authority requirement to translate certain data elements for domestic serious and non-serious case submissions.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>

<\/div>
<\/div>
UltraREG<\/span>

UltraREG is Ultragenic’s proprietary solution that automates data entry and reporting in local languages, fulfilling the Local Health Authority requirement to translate certain data elements for domestic serious and non-serious case submissions.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>

<\/div>

The Challenge<\/h4>

According to Health Authority regulations, Pharma companies must submit their AE (Adverse Event) data to Local Health Authorities in the countries where they sell the medicine. This poses an immense challenge, as most local health authorities require translating certain data elements into local languages for domestic serious and non-serious case submissions before reports can be generated for submission in the Argus safety system.<\/p>\n

The source of the challenge can be traced to the current reporting process followed by pharma companies.<\/p>\n

– Scenario <\/b>1:<\/b> As per the current reporting process, AE cases that do not require Japan reporting are locked and submitted directly to the Global Health Authorities. For submission to domestic health authorities, the report is unlocked to add the local translation and then locked again before transmitting it to them.<\/p>\n

– Scenario 2:<\/b> If a locked case receives significant follow-ups, it is unlocked for further processing. In such a case, the domestic case processors do not get an opportunity to add the local translation for report submission.<\/p>\n

– Scenario 3:<\/b> For AE cases that require Japan reporting, they are locked and moved into the Japan workflow. The local case processors can only access these cases after a Japan lock has been added. They can then unlock the case, add the local translation, and submit it to the domestic health authorities, resulting in significant delays.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section>

<\/div>
[vc_single_image image=”24488″ img_size=”240 x 62″ alignment=”center”][vc_empty_space height=”50px”]

How it works<\/h4><\/div><\/div><\/div><\/div>

Ultragenic’s proprietary solution, UltraREG, provides a complete solution for the above-stated challenges in local data entry and reporting.<\/p>\n

UltraREG has two basic components aligned with the customer’s business process for local data entry.<\/p>\n<\/div>[vc_empty_space height=”20px”]

1. Safety System Automations:<\/strong><\/p>\n<\/div>[vc_empty_space height=”10px”]