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 multilingualism, 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)
Local and Central Lab 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.
Data warehousing enables you to perform
Cross study analysis
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:
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.
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.
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.
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.
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:
One Clinical Data Repository:
Holistic view of all clinical, safety and operational data of a clinical trial in one place
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
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
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
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.
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:
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.
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”.
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.
is Robotic Process Automation?
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.
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.
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.
are some of the key features of Clinevo Safety which uses RPA based
RPA based Dynamic Workflows – Prioritizes the cases based on
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.
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
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.
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.
Robotic Workload Balancer
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.
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 .
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.
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
Automated Traffic-Light Color Coding
PV system also comprises of automated traffic-light color-coding for
providing an intimation about the status of any case.
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.
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.
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.
Automated Daily Report Generation
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.
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.
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.
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.
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:
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:
MAH must collect and report Individual Case Safety Reports (ICSRs), from different sources.
Monthly literature review using electronic literature database is required.
Screening of medical inquiries, internet/digital media, solicited reports, special populations is required.
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.
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 firstname.lastname@example.org