The Challenges of PharmacoVigilance

ABBYY and partner Document Genetics team up to streamline critical business processes

Background
In the face of the growing assortment of pharmaceutical products, PharmacoVigilance, or the pharmacological science of detecting and assessing the side effects of medicines, has become an important issue to both drug companies and consumers alike. In order to identify new information about the hazards associated with medicines and to prevent harm to patients, data from healthcare providers and individuals need to be collected, monitored, researched, assessed and evaluated. The PV evaluation process, however, involves significant amounts of time, particularly to process the large volume of documents.

Because of the resources required to conduct proper PV, drug companies in the UK often turn to bureau service providers, such as Lambda Therapeutic (LT), to help them reduce or eliminate overhead costs. On a monthly basis LT receives an average of 350 forms called ASPRs (Anonymised Single Patient Report) with varying levels of length (from 2 to 10 pages) and complexity (from 50 to well over 100 fields). Each form contains valuable information that must be extracted and fed into a database by an employee – a manual and error-prone process, which takes approximately one hour or more per form, or a total of 400-450 hours per month.

The Solution
In order to find a suitable solution that would help streamline this key business process and save the company time and resources, LT turned to UK-based document management experts Document Genetics. With many years of experience Document Genetics has helped countless organisations of all sizes automate their document processes, something that cuts costs, improves customer service and delivers real business value and intelligence. Document Genetics analysed the situation and determined that a data capture solution was needed to extract the important information from the ASPR forms. Considering the nature of their work, LT needed to be 100% confident that the data would be captured with accuracy, that the data could be verified, and that in case of incorrect entry, any error could be quickly resolved. The company also required that the data extraction software could connect with and easily export information to their self-developed database. Furthermore, as LT would soon be receiving reports from around the world in varying structures, the company needed a flexible system that could adapt to their changing needs.

After testing several options, Document Genetics chose to implement a solution that included ABBYY FlexiCapture. FlexiCapture is a highly intelligent software program that automates the process of pulling specific information from a wide range of documents including forms, invoices, surveys, shipping documents and contracts. It is an ideal solution for many projects because it allows users to build templates for reading key data in a wide variety of documents, extracting value from the information they contain. FlexiCapture is also able to export the data to a number of databases or Document Management Systems and is easily implemented into existing workflows.

The process for LT is now quite simple with the solution from Document Genetics. ASPR forms arrive in both paper and electronic PDF formats. In paper form, an administrator uses an internal office scanner to digitise the documents into PDF format. The PDF is then imported into FlexiCapture, data is intelligently extracted and verified, and at the end of the process they output two data files – a searchable PDF document for archiving and an XML file containing the data. The processing of electronic ASPRs (received in text searchable PDF format) is essentially the same but without the need to scan the paper form. Once the data has been extracted it is fed into LT’s database. At the same time, Formate, a software package provided by Document Genetics, takes the XML data that FlexiCapture has created and uses it to automatically build a spreadsheet that is used by LT for internal purposes.

The Outcome
LT have seen a number of benefits from their new automated solution. Previously, it was a resourceintensive process to manually enter case data into the database and difficult to do anything else with the data once it was there. Now, by using ABBYY FlexiCapture coupled with Formate, LT can eliminate the time wasted on manual data extraction and automatically create the required XML output for their database and populate the spreadsheets with case data. The time-savings for LT has been significant – previously a single person processed on average 8 ASPRs per day; using ABBYY FlexiCapture up to 160 ASPRs are processed in the same amount of time. This represents a 20-fold increase in productivity! “We recognized right away that ABBYY FlexiCapture could help us remove the repetitive and timeintensive manual work of entering our cases directly in our database”, says Grant Mccormak from LT. “It had the added advantage that we could configure a set of simple rules to check that the data was 100% correct and in a format we needed. In doing this we managed to automate the whole input and quality control process into one simple and easy to use step. Document Genetics always focused on our needs as a customer and we have been very pleased with the results of their work.”