CIO Bulletin

Developing Excellent Regulatory Compliant Technology Solutions for Clinical Trials & Pharmacovigilance: Clinevo Technologies

Clinevo Technologies is a Software Development Company specialized in developing and implementing robust technology solutions for Life Sciences R&D. The company helps Pharma, Biotech and CROs in reducing their time and cost in Clinical trials by implementing innovative technologies that involves Data warehousing, Analytics, Collaboration, Automation, and Artificial Intelligence. Clinevo is committed towards delivering the most efficient and practical end-to-end solutions with HIPAA, GXP, CSV, 21 CFR Part 11 and other applicable regulatory guidelines. The company’s unmatched domain experience and technology expertise enables us to deliver best solutions.

Clinevotech software solutions company specialized in clinical trials, data warehousing, and drug safety, eTMF (electronic trial master file) for Pharma, Pharmacovigilance, Biotech, life sciences and CROs in Bangalore, India, USA, and Europe.

The Need for Multilingualism in Pharmacovigilance

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. 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.

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 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 adapted 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.

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. 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 are only single database for all the data, yet there few constraints like performance which degrade for both operational processes and reporting processes. Therefore, Clinevotech creates a database tuned and optimized database which will be ready to answer queries which require bringing 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 provide version controls for the loads and programs which can help convincing the auditors on the data security, data handling and single source of truth.

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. 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.

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. 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.

Meet the leader behind the success of Clinevo Technologies

Mani Vasudevan, Ph.D., is the CEO of Clinevo Technologies. Mani Vasudevan has over 20 years of experience in Clinical Data Management and Pharmacovigilance. He has also led a team of Managers / General manager / Vice Presidents involved in Clinical Trials, Pharmacovigilance and Data Management Services.