Customer understanding

The clients

 Two large and one small  Pharma Companies with the need to prepare Mandatory Reports by searching regularly (weekly or monthly) extensive amounts  Regulatory or Medical Literature Data.

 All the companies are active internationally and their activities require (for strategy and regulatory reasons)  the collection, verification and analysis of relevant quantities of data coming from the scientific literature (Pubmed) and from Regulatory Information databases (both institutional and commercial).

Project Scope

  • ProductLife Group (PLG) began working with the clients initially to carry out Regulatory/PV intelligence covering local and /or global mandatory requirements .Main stakeholders were the RA and PV departments,. These clients, after collection and consolidation also had the need to have the information reviewed by PLG SMES, analyzed, formatted and delivered.
  • The amount of data to be checked periodically (on a weekly or monthly basis) is about 1000 products and 500 APIs.
  • Clients need:
    • Precision
    • Accuracy
    • Timely delivery

Context and solution provided by PLG

  • All the processes were very time, repetitive (given the amount of steps and operations have to be done for each result) and prone to errors (e.g. oversights, mismatches, errors in copying/pasting data etc..).
  • In addition, the results of each search were to be converted in a specific tailored  format and archived  according to clients needs, another time consuming and error-prone task time if done manually
  • PLG created, implemented and validated a set of companywide processes to automate periodic searches, put them in a readable and easy to use format ready for SMEs’ check before the delivery to clients, again in a tailored format.
  • The automated searches are based on a keyword list, which can be updated and /or tailored for the end user
  • After review by SMEs the results are further consolidated, formatted and delivered to the stakeholders
  • The approach used in developing our solutions is based on RPA which is for “Robotic Process Automation”.  PLG can automate the most time consuming, error prone or repetitive activities as a first step and then connect all the sub-processes which are part of the whole process until  an end-to-end workflow is achieved.
  • Tools have been validated comparing results obtained automatically vs. manual searches. A documentation of results was prepared for archival or auditing purposes.

Challenges

The projects with these clients started with relatively few needs and a limited number of products. Over the time, the requests have become more complex and the number products  to search for information have increased dramatically. Given the importance of the quality of the information requested both in the RA and PV fields, customers always ask for precision, accuracy and speed in providing the required documentation.  PLG optimized these routine requests, time consuming and prone to errors with automation.

Added-value and customer benefits

Added-value

  • PLG added-value is to capitalize on each customer: the customer gets the property of its reports but PLG keeps the property of the tool.
  • PLG transformed a manual work into an engineering work. PLG can propose enhanced solutions in the future and guarantee the maintenance of the solutions.
  • The already existing workflow is not disrupted and that the productivity of the routinary processes is improved right from the start with a progressive increase of efficiency .
  • PLG can add consulting on top of the Automated solution. The Reports provided are in fact structured reports with/without advice or impact analysis. If needed by the customer , analysis and  strategic advice by SMEs can be supplied.
  • Easy rightshoring
  • KPIs: 100% correspondence vs. manual processes. 80-90% reduction in the manpower needed

Customer benefits

  • Cost/effectiveness and quick turnaround
  • Flexibility, scalability and reactivity to changing situations (e.g. the COVID pandemics caused a 3-fond increase in the amount of material do be processed)
  • Quality: no oversights, no errors;

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Case Study: “Robotized” Literature and Regulatory Information  Searches