Challenges

The regulatory agencies have enforced strict guidelines to address the safety of the consumer. This has led to Biopharma and Medical Device companies being put under the scanner to abide by the guidelines from regulatory agencies worldwide.

Biopharma and Medical Device companies face challenges to effectively capture all AE (adverse event) and SAE (Serious Adverse Event) cases (incoming via calls or faxes) for all products from all geographies. Compounding this challenge are varying regulations by country on effective reporting to regulatory authorities within stipulated timelines.

Approach

Larger firms with multiple products have preferred to have in- house teams focus on sensitive/complex products so that they can dedicate more time for quality tasks and outsource the management of calls during night-time hours, national holidays or calls on low-yield products to PharmCentre. With our 24x7 multilingual safety call center, we ensure that no call is missed, and thereby reduce the risk of regulatory warnings or drug recalls.

For smaller and medium firms, it’s a big burden to manage the entire safety life-cycle in-house. It is extremely challenging to manage an in-house call center especially for just a few products. This not only increases the burden on medical directors, but may also limit them for tactical activities. PharmCentre can provide solutions initially until the company team is capable of processing and reporting an in-house AE and SAE or ADR (Adverse Drug Reaction) calls fulltime and we’ll transition our processes accordingly.

PharmCentre has the access to log cases in the Oracle AERS (our in-house system) or if needed it can enter the cases in other systems that the sponsor owns. In addition, this department is supported by our PV CRM that manages all call activity. With cutting edge secure IT technology, our team has experience in handling data entry and management in off site or remote access locations to the client safety data base (Oracle AERS, ARISg and proprietary safety data bases).

We can also customize the solutions to match unique needs irrespective of the size of the process or volume of calls or geographical reach. With our experienced PV team onboard, we have consistently met all of the regulatory time deadlines.