Business Process Assessment Template

Pharmaceutical and biopharma companies are appropriate by authoritative compulsions to apparatus a pharmacovigilance/drug assurance surveillance programme and adviser the assurance profiles of their marketed articles during the complete artefact lifecycle. 

Companies accept added started absorption on the reorganisation of biologic assurance and accident administration programs to facilitate proactive identification and anticipation of assurance signals and benefit-risk appraisal for marketed medicines, forth with amalgamating abstracts sets beyond all the stakeholders (pharmaceutical companies, authoritative authorities, patients and healthcare providers) to empower complete transparency, administration and partnership. 

Also Read: Department of Pharmaceuticals proposes to abate time for authoritative approvals by 50%

Numerous assurance databases accessible in the bazaar like Oracle Argus, ARIS-G etc. are acclimated by the industry to action and address adverse contest (AEs) to bounded authoritative authorities. 

Usually, bags of AEs are candy manually every ages by ICSR (Individual case assurance report) case processing teams at biologic companies or their outsourcing ally that are circuitous in case intake, triage, booking, abstracts entry, affection analysis and medical analysis of alone case assurance letters in the assurance database. Some of these cases are appear to authoritative authorities on an expedited base by acquiescence teams.  

Need for transformation to acute case processing 

With the evolving authoritative ambiance and added authoritative scrutiny, accretion ache complication and cardinal of drugs accepting approved, growing acquaintance with patients and providers about advertisement of adverse events, amusing media connectivity consistent in a huge arrival of abstracts and antecedent abstracts with assorted templates or formats, there is accretion charge for biologic companies to arrange and advance added circuitous PV systems and administer assurance surveillance activities added anxiously and proficiently than ever. 

It’s a charge of the hour to revisit the acceptable chiral methods of case processing due to both the bargain accumulation of assurance aptitude vis-à-vis appeal and pressures on the companies to abate the costs of chiral case processing due to the accretion cardinal of adverse contest accepting appear year on year. 

As per the address appear by Deloitte, biologic companies are allocating 40-85 % of PV budgets on case processing, and case volumes are accretion at a amount of 10-15 per cent per year. 

As mentioned in the report, abbreviation the amount of case processing was the primary ambition for 90% of respondents and analysis respondents accepted automation to bear the amount accumulation of 30% per ICSR. 

Also Read: India one of the best vulnerable, atomic able countries for automation

Automating case processing: technologies and benefits 

Automation action accomplishing roadmap would alpha about with action mapping and appraisal to drive improvements in process, authoritative end-to-end case processing bacteria and above and eradicating repetitive accomplish in accepted processes.  

Artificial Intelligence technologies starting with basal automation through RPA (robotic action automation) to cerebral automation with NLP (natural accent processing) and assuredly demography to ML (machine learning) can be activated in the transformation of pharmacovigilance case processing to accomplish it smarter at every date with bottom animal intervention.  

Even admitting there are accepted cloud-based platforms like Oracle Argus, ARIS-G etc. automating case processing and advertisement activities, the action still requires a lot of chiral assignment in case assimilation and abstracts entry. 

The rules-based, alternating and generalised attributes of these processes marks them an ideal fit for automation by application RPA/AI technologies through identification of patterns in baggy data. 

The accomplished process, from case cancellation to reporting, can be automated, thereby abbreviation chiral action to assertive tasks like administration exceptions, affection ascendancy and medical review. 

Strategies of standardisation and automation of PV processes advised with accumulated skillsets of pharmacovigilance area experts, abstracts scientists and IT engineers accept the adequacy to enhance the case action ability by 20-30% ultimately accidental to cogent amount reduction, abbreviation chiral errors appropriately convalescent the affection deliverables to >99% and ensuring 100% authoritative acquiescence due to the bigger turnaround time. 

Adoption of these atypical technologies appropriately can accompany a new akin of acceleration and intelligence to the pharmacovigilance action and can be accomplished through bright eyes and categorical strategies and affairs of accomplishing with mileposts to clue the advance at anniversary footfall and metrics to clue the capability and benefits.

Companies that accept the acceptation of amalgam these atypical confusing technologies and harnessing them would about transform the biologic assurance mural and would be added able in managing the growing case volumes with bigger affection and ultimately acknowledging with the authoritative obligations accompanying to assurance surveillance of their products.

(Dr. Pramod Dhembare, Founder and Managing Partner, Fidelity Health Service .) 

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Business Process Assessment Template

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