Pharma, Biotech, CRO and Life Sciences companies have pharmacovigilance as a mandatory regulatory responsibility. As there’s an exponential increase with the volume of Individual Case Safety Reports (ICSR) increasing every year it has become quite mandatory to design an automated solution for the largely manual pharmacovigilance process for these companies.

What is Robotic Process Automation?

Robotic process automation is one of the emerging forms of business process automation technology based on the notion of metaphorical software robots or artificial intelligence.

The current wave of automation in the pharmacovigilance industry usually refers to Robotics also known as RPA (Robotic Process Automation), where the repetitive manual steps can be automated and no human intervention is required. Repetitive tasks performed by the robotic process can remarkably help in reducing the dependency on humans with a direct increase in efficiency and also improvement in productivity, compliance, and the overall quality.

About Clinevo Safety

Clinevo Safety is a cloud-based, user-friendly, easy to use, regulatory compliant, end-to-end Pharmacovigilance / Drug Safety System. This all-in-one system provides PV Intake, Case Processing, Regulatory Submissions / AS2 Gateway, Analytics, and Safety Signals Capabilities under one platform.

Robotic Process Automation in Clinevo Safety

Clinevo Safety has been designed with regards to the robotic process automation automating some of the key process to achieve maximum productivity at the same time keeping track of compliance where the humans can fail to complete the processes with accuracy and efficiency.

Below are some of the key features of Clinevo Safety which uses RPA based automation:

1. RPA based Dynamic Workflows – Prioritizes the cases based on seriousness

Traditional standard workflows:

In the traditional PV system, the workflow is completely fixed where for the entire organization and for all the scenarios the workflow is going to be standard. Be it a serious case, non-serious case, etc., the workflow is going to be exactly the same.

For Example: The admin will only be able to set a fixed time period of up to 15 days or less for every type of case making every process completion utilizing the same amount of time irrespective of the seriousness of the case. This will make the process slower and inefficient.

Dynamic workflows:

Clinevo Safety provides RPA based dynamic workflow to create different workflows for different types of cases. The feature enables the time period to be easily changed for all the cases and not lock them into a specific schema.

For example: For a serious case, the admin can set the duration of the complete process as 5 days and set 2 day for the completion of Data Entry and 1 day each for the other three processes, whereas he can set a 15 day duration for a non-serious case and can assign 4 days for Data Entry, 4 days for Quality Review, 4 days for Medical Review, 3 days for Reporting or whatever sequence he requires. Similarly, he can assign the 4 days to the serious and death cases giving 1 day each for every process and so on.

Based on the setup by the administrator, the system will automatically determine which workflow has to be followed for any case and performs the case assignment automatically. Hence Prioritizing the cases on its serious is completely automated.

2. Robotic Workload Balancer

Usually the case assignments are manual where there is a need of a workflow manager who has to determine the complete load of every individual manually and assign the cases. Sometimes, he has to wait for someone to take up a case from the respective group.

Along with the manual case assignment option, Clinevo Safety provides an Automated Workflow Manager which enables the system to determine the workload of every individual and assigns the cases to them based on their availability, current workload and capacity by examining their history of case handling.

If the bandwidth of the team is completely utilized and the system determines that the case cannot be processed on time, it triggers alerts to the reporting managers for taking the case on manual assignment mode .

3. Robotic Case Monitor

Clinevo Safety has a RPA based monitor for monitoring and reporting (sending auto-notifications) to the process groups/ workflow manager/ head of the department whenever there is any pending case from any group performing the processes is observed.

The feature allows the system to give intimation in the form of an automated email to the concerned personnel about the due dates and sends follow-ups if the case hasn’t been dealt with within the required time period. The feature also escalates the issue to the person in charge of the pharmacovigilance of that company. It ensures you don’t fail to complete any case due to uninformative reasons.

4. Automated Traffic-Light Color Coding

The PV system also comprises of automated traffic-light color-coding for providing an intimation about the status of any case.

There are three colors visible in front of every case. Green is referred to a case that is processed right on time, Yellow is for a case that is nearing its due date and Red is for a case that is already overdue and is yet to be processed.

The color coding makes it easier for the users as well as the administrator of the system to have knowledge about the status of their cases and help in a timely procession of each case.

The list of the color-coded cases is visible on a highly interactive customizable dashboard which makes the system excessively user-friendly. This list enables the users to be well aware of the status of every case they’re handling.

5. Automated Daily Report Generation

The system also has the ability to generate daily status reports on an everyday basis. The report provides an overview about the status of every case at each processing phase.

The status of the cases is available on the interactive dashboard. It also generates automated notifications in the form of emails which consists of information regarding the same. The report helps the users as well as other concerned personnel to stay updated about every case and the process it’s going through.

Conclusion

In comparison to the existing systems in the market, Clinevo Safety has the following features which are enabled by RPA:

1. Clinevo Safety is prioritizing the cases (serious cases) that have to be taken over before the other cases (non-serious cases).
2. Automatic workload balancer will ensure the work is shared among people and high productivity is achieved.
3. It automatically sets the due dates for all the cases and their processes and sends automated follow-ups keeping you updated about the status of every case.
4. It also sends automated alerts to the concerned person when there has been no action taken for a certain case when it is nearing its due date.
5. Overall, it tracks all cases ensuring that none of the cases are gone out of hand and are efficiently processed on time.

Thus, the application of RPA features in Clinevo Safety makes it a highly productive, reliable and efficient PV system resulting to improved compliance and productivity in pharmacovigilance.

Author: Arunkumar Devaraj, Director of Products and Solutions, Clinevo Technologies.

Date: 17-Jul-2019

The Indian Pharmacopeia Commission published a Pharmacovigilance Guidance Document for all Market Authorization Holders (MAHs) of Pharmaceutical Products in India, which was effective January 2018. The new guidance is heavily influenced by USFDA and EMA Pharmacovigilance regulations.

According to the guidelines: “MAHs are required to collect and process comprehensive safety information related to pharmaceutical products and reports to the regulatory authority within the prescribed timelines. Every MAH shall have a system in place that ensures the overall quality of AEs/ADRs.” Term “MAH” refers to the manufacturer or importer of the drug, who has a valid manufacturing or import license in India”.

According to the guidelines, below are the 6 key components that a Pharmacovigilance department of a MAH should consist of:

1. Pharmacovigilance System Master File (PvMF) & Pharmacovigilance Officer In-charge (PvOI):

• PvMF: (similar to the pharmacovigilance system master file PSMF) must contain all the information related to the MAH’s PV system, including the PV Officer In-charge (PvOI), PV organization structure, sources of safety data, PV processes and PV systems.

• PvOI: PvOI shall have sufficient authority over the pharmacovigilance system and be responsible for compliance. The PvOI is mandated to be a Medical Officer or a Pharmacist trained in the collection and analysis of Adverse Drug Reaction (ADR) reports.

2. ICSRs and Pharmacovigilance Database (Software):

A Pharmacovigilance database may be required to do the mandated activities mentioned below:

1. MAH must collect and report Individual Case Safety Reports (ICSRs), from different sources.
2. Monthly literature review using electronic literature database is required.
3. Screening of medical inquiries, internet/digital media, solicited reports, special populations is required.
4. The MAH is required to code ADRs using a dictionary.

Importantly all ICSRs received by MAHs are mandated to be submitted to PvPI in XML-E2B format.

3. PSURs – Periodic Safety Update Reports (PSURs):

PSURs shall be submitted every six months for the first two years after approval of the drug and annually for the subsequent two years unless extended by the licensing authority in the interest of public health. PSURs due must be submitted within 30 calendar days of the last day of the reporting period.

4. QMS – Quality Management System:

QMS must be in place to monitor the quality cycle of the pharmacovigilance system, quality objectives for pharmacovigilance, responsibilities of the quality system, training of MAH personnel, and required facilities and equipment, with special emphasis on compliance management, record management, documentation of the quality system, and critical pharmacovigilance processes.

5. PV audits and inspections should be conducted both internally and externally to the PV systems.

6. RMPs: Risk Management Plans, including the objectives, their content and risk minimization activities, and highlights specific pharmacovigilance activities must be in place. The general understanding is that an RMP must be submitted at the time of product approval and/or upon request by the competent authorities, although it is not explicitly mentioned in the guidelines.

Although complying with the pharmacovigilance requirements pronounced by this guideline may be quite challenging there are provisions for outsourcing most of its mandated activities to Pharmacovigilance vendors. With India serving as the global capital of pharmacovigilance outsourcing today, MAHs may make use of these provisions and quickly augment their Pharmacovigilance systems by choosing appropriate pharmacovigilance partners.

For the drug manufacturers/MAHs who do not yet have PV systems in place, implementing these changes can seem to be an insurmountable task. However, we already have an end to end Pharmacovigilance database/software in addition to the services needed to address the new requirements. We can help companies to establish and maintain a PV system, Call Center, Screening Literature and Social Media Cases, QMS, PvMF, ICSRs, PSUR, RMP and Signal Management. In addition, we can also provide support on the PvOI and PV audits. We can help you in the transition to the new requirements and address your end to end PV needs.

If you are interested in learning more about Clinevo’s PV Software and Services, please contact us at arun.d@clinevotech.com