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Medicines and vaccines are remarkable tools for improving health and saving lives. Yet, even with rigorous testing, they’re not without potential risks. That’s why we need pharmacovigilance.

Hold up, what’s with this “pharmacovigilance” jargon? Think of it as the science of keeping tabs on meds and vaccines, making sure they’re doing their job without any nasty surprises.

Why Not Stop With Just Clinical Testing 

While clinical trials play a vital role in assessing safety and efficacy, they have limitations. They involve a relatively small group of participants and a restricted time frame. This means that rare or longer-term side effects might not be identified until the medicine or vaccine is used by a larger, diverse population over a longer period. This is why we need to know the importance of pharmacovigilance.

Continuous Monitoring: 

Pharmacovigilance isn’t a one-time event; it’s an ongoing process. Once approved, medicines and vaccines are continuously monitored to ensure their continued safety and effectiveness. This involves several key players:

Patients:

  • Report any side effects you experience: Even if unsure if the medicine caused them, reporting helps build a comprehensive picture of potential risks.
  • Read the package insert: This information leaflet provides details about known side effects and helps patients understand what to watch out for.

Healthcare Professionals:

  • Report any side effects observed in your patients: This includes both confirmed and suspected reactions.
  • Share relevant information with patients: Help them understand the importance of reporting and how to do so effectively.

Market Authorization Holders (Pharmaceutical Companies):

  • Proactively monitor and report side effects: As the product developers, they have a crucial responsibility to track and report any safety concerns.
  • Collaborate with regulatory agencies and healthcare professionals: Sharing data and insights is essential for understanding and addressing potential risks.

What to Report

The information leaflet accompanying any medicine provides details on potential side effects. 

However, it’s important to report any unexpected reactions, especially:

  • Serious Adverse Reactions: Any effect that results in death, life-threatening conditions, prolonged hospitalization, disability, or other serious medical events.
  • New Medicines and Vaccines: Any reactions observed with recently introduced products.
  • Medication Errors: Cases where the wrong medicine, dose, or administration route was used, leading to serious harm.
  • Lack of Efficacy: If the medicine seems ineffective in its intended purpose.
  • Overdose and Off-Label Use: Any serious reactions resulting from taking more than the recommended dose or using the medicine for a purpose not approved by regulatory authorities.
  • Suspected Product Defects: If you believe the product itself might be faulty and causing adverse reactions.

What constitutes “serious”?

  • Death
  • Life-threatening situations
  • Hospitalization or extended stays
  • Permanent disabilities or birth defects
  • Other critical medical interventions

Importance of Pharmacovigilance in Identifying and Documenting Adverse Reactions

1.Reporting as a Patient:

As a patient or caregiver, you witness firsthand how a particular medicine or vaccine impacts your health. If you experience any unexpected symptoms or changes in your well-being after taking a medication or receiving a vaccine, don’t hesitate to report it. Even seemingly minor side effects can provide valuable insights.

Why Report as a Patient?

Every report you submit contributes to a larger network of information, making medicines and vaccines safer for everyone. While extensive testing happens before these products become available, unexpected side effects sometimes emerge when used by a wider population. Your report could

  • Identify previously unknown or uncommon side effects.
  • Lead to updates in product information or labeling to better inform users.
  • Prompt regulatory actions like product recalls or adjustments if necessary.
  • Contribute to international data analysis, leading to improved understanding of overall benefits and risks.

How to Report as a Patient:

  • Talk to your doctor or pharmacist: They are best equipped to assess your symptoms and understand potential connections to the medication or vaccine.
  • Use online reporting systems: Many countries have user-friendly online platforms for reporting side effects. For example, in India, you can use the Pharmacovigilance Programme of India (PvPI) portal.
  • Contact your national regulatory agency: Most countries have specialized agencies responsible for monitoring drug safety. They might have alternative reporting channels for patient use.

2.Reporting as Healthcare Professionals 

Doctors, nurses, and pharmacists play a critical role in identifying and reporting side effects. Your expertise in patient care and understanding of medications makes your reports invaluable.

Why Report as a Healthcare Professional?

You see a wider range of patients and potential reactions than individual patients do. By reporting, you

  • Contribute to a more comprehensive picture of medication and vaccine safety.
  • Help identify trends and patterns that might otherwise go unnoticed.
  • Assist in ensuring the best possible care for your patients and future generations.

How to Report as a Healthcare Professional

  • Use established reporting systems: Most countries have dedicated healthcare professional portals for reporting side effects. These portals often offer additional resources and guidance.
  • Follow your national regulations: Many countries mandate healthcare professionals to report specific types of side effects. Familiarize yourself with your obligations.
  • Encourage patient reporting: Educate your patients about the importance of reporting side effects and provide them with easy access to reporting channels.

3.Reporting as Pharmaceutical Industry

Pharmaceutical companies have a primary responsibility to ensure the safety of their products. This includes actively monitoring and reporting adverse events.

Why Report as a Pharmaceutical Company?

  • Proactive reporting demonstrates your commitment to product safety and transparency.
  • Early identification of potential issues allows for swift corrective actions, minimizing harm to patients.
  • Your data contributes to the broader understanding of medication and vaccine safety, benefiting the entire industry.

How to Report as a Pharmaceutical Company

  • Follow regulatory requirements: Each country has specific regulations for reporting adverse events by pharmaceutical companies. Adherence is crucial.
  • Maintain robust internal reporting systems: Ensure your company has efficient mechanisms for collecting, analyzing, and reporting data on adverse events.

Collaborate with regulatory agencies: Work openly and transparently with regulators to facilitate effective monitoring and safety measures.

What is Clinical Trial Management System?

February 1, 2024 | Uncategorized | No Comments

The process of conducting clinical trials on drugs is a very complex and challenging task.To simplify this procedure and approach this challenge in a more systematic manner software like Clinical Trial Management Systems.

Introduction

Clinical trial management system AKA CTMS bring together Researchers, Co-Ordinators, Stakeholders together on one platform to plan, track, manage clinical trial activities on drugs. Some features include participant enrollment, tracking, study document management, daily study visits, monitoring progress, data collection, data analysis, compliance management, financials etc. All these features come on one single platform. No need of paper work or manual systems, hence reducing the human clerical error to a very huge extent.

Benefits of CTMS

Enhanced Efficiency and Productivity

Like the heading says Efficiency, productivity are one of the key benefits of CTMS. Activities like manual and repetitive tasks like data entry, document and participant tracking are automated, allowing researchers and study co-coordinators to focus on other critical activities.

Improved Data Accuracy and Integrity

Data accuracy is pivotal in all Clinical trials. CTMS achieves this by data entry forms standardized across the entire clinical trial. Data validation, real time monitoring are other added benefits. Hence again reducing errors and inconsistencies and getting more trustworthy results.

Regulatory Compliance

Regulatory compliance is very complex and tedious making the entire process prone. With a CTMS in place, all the compliance are already keyed in and ready in the system. With simple easy to use features like drag and drop, selecting a process gives the users a predefined approach, hence reducing the compliance violation cases and avoiding penalties

Some Key features of Clinical Trial Management System

Participant Enrollment and Tracking

This features screens participant eligibility, tracks participant visits and interventions. Also users are prompted for electronic informed consent which is again an automated process, further simplifying the operations of participant management.

Study Document Management

Document management is critical as procedures for Study protocol, consent forms for participants, case reports and other regulatory documents are to be managed in a structured manner. Electronic documents are then stored securely for later sharing, organizing, easy access and version control.

Monitoring and Reporting

Monitoring and reporting in a CTMS covers

  • Real time study status updates
  • Data monitoring
  • Data verification
  • Generating Simple and Comprehensive or custom reports.

Aiding researchers to quickly identify any any discrepancies and immediately action on it

Financial Management

Some financial modules covered are Budget allocation i.e. Example payment, invoicing for participant trials to be captured in the system which can then be integrated with the financial system.

This integrates facilitates tracking of expenses, financial reports generation.Ensuring transparency, accuracy and giving visibility to track costs of the project and prioritize budgets.

How a Clinical Trial Management System can improve efficiency

Clinical trials are complex and expensive to manage and execute. But with CTMS, these all can be streamlined read on to check the various aspects.

Streamlining of Participant Management:

  • Eligibility screening
  • Randomization Screening
  • Participant visit tracking
  • Interventions (When required)

can be automated with CTMS saving time, resources and reduces the risk of errors

Automated Data Collection & Analysis

Data collections can be automated by

  • Providing standardized data entry form
  • Data validation
  • Built In Data analysis tools of accumulated data.

This allows to analyze and interpret more easily

Efficient Document Management

A CTMS is all about documentation, a good CTMS Simplifies documentationCentralized Platform to store, organize and share documentsProvides Version control, collaboration among teamsProvides quick document retrieval reducing administrative burden

Real-time Monitoring and Reporting

  • Real time monitoring with reporting capabilities
  • Facility to update the studies and provide stats updates
  • Create and execute simple, comprehensive and custom reports

The above features allows for quick problem identification.

Choosing the right Clinical Trial Management System for your organization

Here are some key factors to consider when selecting a CTMS:

Identify Your Organization’s Needs

Some immediate factors are

  • Complexity of Clinical Trials
  • Size of the trial
  • Numbers of users
  • Any specific functionality towards the trials.

Evaluate User-Friendliness and Accessibility

A CTMS is only as good as how user friendly and ease of use is..

  • Easy Navigation
  • Intuitive interface
  • Custom Workflows
  • Easily accessible from different devices (Ideal for employees who are working from home)

Consider Integration Capabilities

This is cruicial as when CTMS has to handshake with existing systems in the organization like Electronic Data Capture Systems, Electronic Health Records etc Data should be able to seamlessly flow between both the organization servers/infrastructure and CTMS servers/infrastructure.

Evaluate Data Security and Compliance

Clinical trials consist of sensitive participant or patient information. Checks for data security standards, access controls & encryption during transition, check for regulatory compliance too, some of them are managing regulatory documents, conducting audit on the trials.

Implementing a Clinical Trial Management System in your organization

Define Your Implementation Strategy

Some check below are

  • Team Size
  • Setting Clear Goals and objectives
  • Timeline for implementation completion

The more the detailing the better the transition

Customize the CTMS to Your Organization’s Needs

  • Custom workflows
  • Creating custom data points (Data entry forms)
  • Integration with CTMS

With these points we can maximize on the benefits

Provide Training and Support to Users

  • Training of using the platform
  • Successful adoption with proper knowledge transfer
  • Post implementation support

These check points will instill comfort and confidence during this transition to a new CTMS

Monitor and Evaluate the Implementation

  • Evaluate the effectiveness during during equal intervals. (Which can be achieved through consistent monitoring)
  • Encourage user feedback
  • Rate user satisfaction
  • Revised training on new modules that are updated.

Best practices for using a Clinical Trial Management Software

  • Work on consistency and efficiency by standardizing workflow and processes.
  • Define protocols rights from participant enrollment to document version updates
  • Update the Clinical Trial Management Software to the latest versions by updating the latest security patches etc
  • Cleaning of outdated or duplicate information across all departments
  • Encourage teamwork by fostering collaboration among fellow researchers.
  • Ensure every one in the team is updated with the latest update in the clinical trial process
  • Train and educate users on how to use CTMS with regular training, sharing the latest features and functionalities, advise the best practices etc

The future of Clinical Trial Management Systems

  • CTMS to integrate with Electronic Health Records are becoming a necessity
  • Integration for seamless data exchange and real time access to participant or patient information.
  • Adoption of Artificial Intelligence and Machine Learning in to the CTMS Modules to help identify and automate repetitive tasks
  • With Artificial Intelligence and Machine Learning we can identify patterns and trends in large datasets allowing researchers to take data driven decisions.
  • CTMS should be Mobile friendly
  • Encryption to protect from intruders Patient Sensitive data.
  • Adherence to privacy regulations like GDPR

Top Clinical Trial Management System software providers

Some top companies that we can recommend are

  • Clinevo Technologies
  • Medidata Solutions
  • Oracle Health Sciences
  • BioClinica
  • Veeva Systems

Clinical Trial Management System (CTMS) plays a crucial role in improving the efficiency and effectiveness of clinical trials.

Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

Pharmacovigilance being an extensive part of healthcare and clinical trials requires the combination of deep understanding of medical translation with the intricacies of clinical research, marketing and reporting. Some countries have made the reporting in their local language mandatory.

The Need for Multilingualism in Pharmacovigilance

There’s a growing urgent need for accuracy in translation of clinical documentation and reporting; from pre-marketing clinical testing, adverse event / pharmacovigilance reporting, coding and word-to-word documentation. For some regulators, there is a requirement for the data to be processed and reported in their local language.

For countries like Japan and China, new rules for pharmacovigilance are on the way. CROs, biotech and pharma companies from these countries will soon be required to submit their regulatory reports in their national languages by the end of 2020.

The existing traditional systems can only support English as the language and even if some systems have the capability to provide a setup for any other language such as Chinese, Japanese, etc. or can convert a language into another, they tend to charge a substantial cost for the same.

Multilingual system would also be of great use as the local pharmacovigilance employs of these countries can complete all the processes efficiently and in little time when provided with an ease of their local language on the PV systems.

Not only in Japan and China, but multilingual PV systems would be extremely beneficial to all the countries in all parts of the world.

Clinevo Safety & It’s Multilingual Capabilities

Clinevo Safety is a cloud based, user-friendly, easy to use, regulatory compliant end to end Pharmacovigilance / Drug safety system. All-in-one system provides PV Intake, Case processing, Regulatory submissions / AS2 gateway, Analytics, and Safety signals capabilities under one platform.

It is supported by technology that enables quick turnaround of your specialist requirements. Clinevo Safety can process data in any language like German, Japanese, Chinese, etc. The complete system gets adopted to any language with just an admin configuration.

Apart from just multilingual capabilities, Clinevo Safety also offers dual language support where all the text is available in two different languages and these languages can be set according to the user preference. The multilingual and dual language capability of Clinevo Safety makes it a language friendly, efficient and cost-effective multilingual global system.

Data collected in clinical trials are complex, vast and growing uncontrollably with the number of clinical studies, clinical research softwares and vendors present in the clinical research market. For one study, a Clinical research company must work with several different vendors and software including

  • CDM/EDC Systems (like Oracle Clinical/RDC, Inform, RAVE, Open Clinica, Clinevo EDC etc.)
  • Safety Systems (like Argus, ArisG, Clinevo Safety, etc.)
  • CTMS Systems (like Siebel Clinical, Clintrace, Clinevo CTMS)
  • SAS-Based Systems
  • Cloud-Based Systems
  • Legacy Systems
  • Spreadsheets
  • Local and Central Lab Systems
  • EMR/EHR Systems
  • Regulatory Submission Systems.

Can you store, access and interact with all your clinical trial data in one place?

Data from all these different systems/sources being in different formats, makes impossible to get all the data in one place.!

What is a Clinical Data Warehouse?

A Clinical Data Warehouse or a Clinical Data Repository is a real-time database that consolidates data from a variety of clinical, safety and non-clinical sources to present a unified view.

All the data like Clinical Data, Operations Data, Safety Data, Lab Data and other data of one study can be available in one place for review, reporting and analytics. A Business intelligence tool in combination with a Data warehouse can enable you to know the progress of the trial in real time and enables you to monitor and take right decisions at the right time.

  • Storage
  • Review
  • Standardization
  • Aggregation
  • Analysis
  • Submission

Data warehousing enables you to perform

  • Cross study analysis
  • Data harmonization
  • Data reconciliation
  • Data recording
  • SDTM transformation
  • Data Aggregation and
  • any business processes

Purpose of a Clinical Data Warehouse:

Purpose of Clinical Data Warehouse lies somewhere in its definition itself i.e. a database created by combining data that is gathered through various sources that can be of different types and formats (e.g. oracle, SAS, text, sql, xml etc.).

In a nutshell, Data Warehouse is a process of collecting data, transforming it, loading into single database and then using a BI (Business Intelligence) tool to answer your analytical queries and prediction of any further questions that may arise are helpful to your domain or business.

Benefits of a Clinical Data Warehouse:

Below are a few benefits of implementing a Clinical Data Warehouse for your Clinical Trials:

  1. Improving Visibility of Data / All-in-One Platform:Clinical research organizations process data in different systems, which support the various business processes. In order to create an overall picture of clinical, operations, safety, non-clinical, lab and other data for sponsors and CROs – thus creating a single version of the truth – the data must come together in one place and made compatible. Both external (from the environment) and internal data (from various systems) should merge into the data warehouse and then be grouped. Therefore, having a single source to answers all your queries.
  2. Improved Performance: One could use an already existing operational database if there is only single database for all the data, yet there few constraints like performance which degrade for both operational processes and reporting processes. Therefore, we create a database tuned and optimized database which will be ready to answer queries which require to bring huge amount of data and analysis.
  3. Increase Data Quality: Users frequently overestimate the quality of data in the source systems. Unfortunately, source systems often contain data of poor quality. When we use a data warehouse, we can greatly improve the data quality, either through – were possible – correcting the data whilst loading or by tackling the problem at its source.
  4. Faster Decision Making and More advanced Reporting: The structure of both data warehouses enables end users to report in a flexible manner and to quickly perform interactive analysis based on various predefined angles. They may, for example, with a single mouse click jump from year level – to quarter – to month level and quickly switch between the clinical data and the operational data whereby the indicator remains fixed. In this way, end users can juggle with the data and thus quickly gain knowledge about business operations and KPIs (Key Performance Indicator). Some metrics like – Which Site is not performing well? Which Investigator is not performing? Which patient is not regular for trials? Can be zeroed in in no time to find out the bottle necks of a trial and take necessary action time to avoid delays in the trails because of non-performing factors.
  5. Regulatory Compliance: Clinical data warehouse stores audits of every action and stores data snapshot of data of different timestamps and provides version controls for the loads and programs which can help convincing the auditors on the data security, data handling and single source of truth.

About Clinevo Data Warehouse:

Clinevo Data Warehouse is an easy to use, secured, regulatory compliance clinical trials data repository & warehouse to acquire, store, transform, consolidate and report diverse data of clinical trials in one place.

Features of Clinevo Data Warehouse:

  1. One Clinical Data Repository:
    • Holistic view of all clinical, safety and operational data of a clinical trial in one place
  2. Wide Range of Tech Type Integrations:
    • Oracle, SAS, Text/CSV, XML, SQL Server, web services Imports
    • Oracle PL/SQL and SAS programs
    • SAS, TEXT, XML, Oracle Extracts
  3. Inbuilt Business Process
    • Data Harmonization – Harmonize data from different source structure to one target structure
    • Data pooling – To the database schema (or) to remote DB with security
    • Data masking – supports various approaches
  4. Increased Efficiency and Automation
    • Robust incremental refresh to get the data refreshed within 4 hours from a heavy Source system
    • Incremental data refresh for non-primary key tables
    • Incremental data refresh based on data element group
    • Parallel Data Loading
    • Configurable Automated Data Loads
  5. Clinical Metadata Repository (MDR) Integration
    • Any Clinical MDR systems (COTS) or Legacy systems can be integrated with CLIDAC directly (or) thru web services to get the metadata.
  6. Audit/ Regulatory Compliant
    • 21CFR part 11 regulatory compliance
    • Audit trail for every operation
    • Complete user tracking

Read more about the features of Clinevo Data Warehouse:

https://www.clinevotech.com/products/data-warehouse

Galaxi Consulting is a leading Life Sciences and Manufacturing consulting firm focused on finding the best solutions for Pharma and Biotech clients across Europe and the UK, currently working with the Fortune 100 Pharmaceutical and Healthcare companies. They are also digital recruiters specialized in sourcing and deploying the topmost applicants in the Life Sciences, Biotech, Pharma and Manufacturing sector.

Clinevo Technologies is a Software Development Company specialized in developing and implementing robust technology solutions for Life Sciences R&D. They help Pharma, Biotech and CROs in reducing their time and cost in Clinical trials by implementing innovative technologies that involve Data Warehousing, Analytics, Collaboration, Automation, and Artificial Intelligence.

Clinevo Technologies currently has 3 products on a GxP Cloud:

Clinevo Safety: Clinevo Safety is a cloud based, easy to use, regulatory Compliant, AI enabled, end-to-end Pharmacovigilance / Drug Safety system. This all-in-one system provides PV Intake, Case processing, AI, Analytics, Submissions/AS2 gateway and Safety signals capabilities under one platform.

Clinevo DW and Automation: Clinevo Data Warehousing and Business Process Automation Console is a secured, regulatory compliant Clinical Trials Data Warehouse to Acquire, Store, Transform, Consolidate and Report diverse data from clinical trials in one place and AUTOMATE any of the manual, cumbersome business processes. This platform can enable companies to perform Cross Study Analysis, Data mining, Predictive Analytics, etc.

Clinevo eTMF: Clinevo eTMF is an extendable electronic trial master file in electronic (digital content) format for organizing and storing documents, images, and other digital content of clinical trials.

The Partnership:

Clinevo and Galaxi Consulting are pleased to announce a partnership that extends the power of Clinevo’s innovative cloud-based technology solutions and Galaxi Consulting’s international talent pool of Life Sciences specialists and aimed at helping Pharmaceutical, Biotech and CROs with high performing, GxP compliant Pharmacovigilance and Clinical trial solutions.

This partnership is primarily aimed at cutting down the IT cost in the Life Sciences R&D domain by 75% with unique cloud-based IT solutions.

Arunkumar Devaraj, Director of Life Sciences at Clinevo, said, “We have developed a lot of unique features that would make our products as the best when compared to other existing products in the market. We already have a lot of highly satisfied customers from USA and India market and we are excited to be partnering with Galaxi Consulting and introducing our products to its customers in Europe and the UK”.

Gaurav Sharma, Director, Galaxi Consulting said, “We are highly impressed with the Clinevo’s end-to-end product strategy which brings in a lot of benefits with huge cost savings to the customers who are into Pharmacovigilance and Clinical Trials. With our vast consulting experience in Europe and the UK, we are looking forward to delivering high-quality solutions to the customers”.

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 overall quality, productivity and compliance.

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.

Pharmacovigilance in India

August 14, 2019 | Pharmacovigilance | 2 Comments

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