Dr. Bahadursingh joined ArisGlobal in September, 2016, and brings more than 17 years of drug safety and risk management experience to ArisGlobal’s Safety and Pharmacovigilance business unit. The following is an English translation of a feature by Japan’s Yakuji Nippo

IT solution provider for pharmacovigilance and clinical safety, ArisGlobal KK, has appointed Dr. Krishna Bahadursingh as its new Representative Director. Having a medical background, he has also been concurrently appointed to the position of Senior Vice President of the Safety and Risk Management Business Unit at the US based Global Headquarters. He speaks fluent Japanese and has a deep understanding of the Japanese market, having held leadership roles in Banyu Pharmaceutical (currently MSD K.K.), and Eisai Co., Ltd. In spite of the fact that, there are various challenges involved in post-marketing pharmacovigilance operations at pharmaceutical companies, he has expressed that his commitments are on “building partnerships with Pharmaceutical companies” as well as focusing on trust with those partners.

• ArisGlobal Press Release: Solidifying Growth Strategy, ArisGlobal Hires Dr. Krishna Bahadursingh to Head Safety and Pharmacovigilance Business Unit

ArisGlobal is a major global vendor for drug safety solutions. Transformation of business process is very critical for pharmaceutical companies with limited human resources available in the Pharmacovigilance department. Having held leadership roles in the Pharmacovigilance Department of pharmaceutical companies and hands on involvement in the implementation project of ARISg, a pharmacovigilance system, Dr. Krishna realizes the significance of IT systems in the management, early detection and analysis of adverse drug reactions.

That was one of the major factors in his decision to move from the Pharmaceutical business side to the IT vendor side. He is confident that ArisGlobal has enormous potential with a 30 year record of capabilities in product innovation to support global data analysis. However, he also realizes that there remains an immediate challenge of ArisGlobal being perceived by pharmaceutical companies as not being customer oriented when it comes to support.

Therefore, the first step is to build a solid partnership between pharmaceutical companies and this technology company. A symposium called Industry Standard Platform Japan (“ISPj”) is soon to be established as a basis for driving the development of innovative pharmacovigilance systems, while providing the Pharmacovigilance service package, “Total Safety” solution. This will be a forum for discussions among ArisGlobal users who can exchange opinions with their colleagues from pharmacovigilance department in other pharmaceutical companies.

Through local adaptation of the experiences and expertise from our Global operations, “we would be actively listening to our customers, exchanging opinions and establishing an industry standard platform.” We will be examining the problem of “unreported adverse events” in the industry through the same perspective as any of the pharma industry members. Our priority is to provide a high-quality service at affordable cost to the entire industry rather than customized service per individual company.

In addition to that, we will also be incorporating the latest innovative technologies to enhance “risk management, evaluation and analysis of real world data,” from sources such as social networking services. Safety analysis of data from sites such as Twitter and LinkedIn and dealing with the “big data landscape” will be significant challenges. However, those challenges will not impede our efforts in building trust and focusing on innovative development over the next 2 to 3 years.

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When life sciences companies think about moving to cloud applications, the first question most ask is, “can we be sure the data will be secure?” Companies need to know that medical information about patients can be de-identified and kept safe and that data confidentiality can be guaranteed.

Integral to security is compliance. Life sciences companies must meet a number of regulatory and compliance requirements, such as Health Insurance Portability and Accountability Act in the United States to secure medical information, electronic signature regulations (known as 21CFR Part 11), ISO information security standard 27001, and SOC 2 and similar in country laws for other countries across the globe focusing on nonfinancial reporting controls related to security and confidentiality. Like other industries, life sciences companies should also abide by the EU-U.S. privacy shield framework norms when transferring data intercontinentally.

• Whitepaper: Learn more about ArisGlobal’s agOnDemand Security Framework and our approach to addressing security challenges on SaaS

It’s imperative, therefore, that the flow of information across platforms is secure, while enabling different functions and partners to communicate seamlessly – such as across regulatory information management system software and drug safety systems.

Encryption is an important step in the process to allow data to be masked and unmasked and control who sees the data and how much of the data they see. Life sciences companies also want to ensure their data is segregated from other companies on the cloud, and that data segregation has been tested and demonstrated to be effective.

Vendor Assurance

Nevertheless, software as a service (SaaS) is gathering momentum across all industries, including the life sciences – albeit at a slower pace due to security concerns. What’s important is that any solution is secure and compliant, and serves the needs of the business and data users.

While you are ultimately responsible for the security and integrity of your data, your vendor must share some of the burden of regulatory compliance with you. Certainly, regulatory authorities do conduct audits of vendors’ systems and processes, but best practices can and should go further.

When selecting a SaaS vendor, therefore, it’s important that you ensure you select a partner with the required controls and processes to ensure compliance with statutory regulations, that they have clear audit procedures in place and that you are able to audit your partner, and that they can demonstrate accountability about information security.

There are dedicated, proven SaaS solutions for life sciences companies and then there’s your standard commercial cloud. They’re not the same and what you get from the former must always be suited to your needs in the highly regulated life sciences industry.

Whitepaper:  about ArisGlobal’s agOnDemand Security Framework and our approach to addressing security challenges on SaaS

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Safety is top of mind for regulatory authorities. As a result, agencies are not only taking a harder line on safety but are also introducing advances, including adopting progressive drug safety systems, to underscore their objective of safeguarding patients and consumers.
In Canada, in 2014 the health ministry was given extensive authority to crack down on drugs that are either dangerous to consumers or where adverse event information is withheld. As a result of the bill passed by the country’s House of Commons, Health Canada has since been allowed to demand warning labels or require a product be removed if it is deemed unsafe. In particular, the bill enables – and the agency now requires – absolute transparency.
Even before the bill was passed, Health Canada had begun taking clear steps to ensure greater transparency and better oversight of data. In April 2013, the agency adopted a comprehensive drug safety database to harmonize and improve the reporting of adverse drug reactions (ADRs) and began receiving adverse reaction reports electronically from marketing authorization holders (MAHs) and clinical trial sponsors. They have implemented an E2B gateway solution from ArisGlobal – database to database transmission – for individual case safety reports (ICSRs). Being compliant with reporting requirements, including E2B compliance, being on time, and ensuring quality data are critical.
Good progress has been made: in 2014, more than 250,000 pre and post market electronic reports were received, compared to the approximate 66,000 domestic reports received in 2013, and today the authority has received more than 1 million ICSRs through the gateway since the start of e-reporting. As of July 2016, more than 90% of all domestic and foreign, pre-market and post-market adverse reaction reports received are now being received electronically. The top 20 MAHs make up 88% of the electronic volume and Health Canada is encourage other companies to go electronic.
What does this mean for industry?
Unfortunately, however, all too many companies are still falling behind with their risk evaluation and mitigation strategies. Of the approximately 200 plus companies registered local with Health Canada, around 50 have begun reporting electronically and another 10 are going through the implementation process. As more companies implement safety databases, the authority is encouraging them to be electronic to ensure reporting compliance as well as timely responses on the confirmations. But with many companies still filing manually, questions are raised about their ability to ensure their processes are in compliance with the agency with regards to safety reporting, which is critical for ensuring the safety of their products.
For industry, there’s an enormous amount riding on staying compliant — both in terms of ensuring the safety of consumers and enabling companies to meet their obligations and get or keep their products on the market.
It’s imperative, therefore, that companies find better ways to manage their safety data reporting, including both clinical trial serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSAR), and spontaneous postmarketing adverse events reporting. It’s about processes, it’s about technology, and it’s about keeping up to date with the authorities.
During this blog series, I’ll explore Health Canada’s specific requirements and how they differ from the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) adverse event reporting expectations. I’ll also look at the challenges and potential ramifications of managing safety reporting manually.
Learn more about ARISg and ARISj and why companies and regulatory authorities, including Health Canada, adopt these pharmacovigilance systems for global safety case reporting.

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Pharmaceutical companies face extraordinary demands when it comes to drug safety and risk management. They must adhere to all regulations surrounding adverse event reporting and streamline their risk evaluation and mitigation strategies.
Perhaps the single biggest challenge for companies is meeting timelines, especially when so many are held back by manual, time-consuming processes. Those challenges intensify when handling spontaneous postmarketing adverse events.
If they lack the technology to automate this process, they have to manually identify how many serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSAR) they have to submit. Then once the authority has acknowledged receipt of those reports, the company must maintain a copy of the paper report and manually check and upload those receipts into their safety database. If the authority has any questions, they will have to recheck the information, make corrections and go through the same manual process again.
On top of those challenges, add on the issue of meeting timelines. Health Canada requires that a non-fatal or life-threatening Adverse Drug Reaction (ADR) be reported within 15 days of the company becoming aware of the information. Where the ADR is fatal or life-threatening, companies must report within seven days, and ideally immediately.
More Time, Better Quality
Handling reports manually gives companies very little time to assess, review and verify each case. A manual process makes it difficult for companies to validate the data they are capturing, and they may miss some of the key information that authorities expect them to capture, or they may not report the information that is received or recorded.
On the other hand, a robust pharmacovigilance regulatory reporting system that includes adverse reaction management software not only provides more time for the important assessment and review activities, but automates sending the cases and receipt of acknowledgements. Additionally, a drug safety system can identify whether cases have been reported and alert pharmacovigilance departments if they are overdue.
Data quality is imperative in an age where regulators are laser-focused on safety. With a drug safety system that aligns with regulatory authorities’ requirements, companies will be able to demonstrate that compliance checks have been done, will be better placed to ensure the quality of their data and will be able to respond quickly to any potential audits and inspections.

As the authority automates processes to ensure reduced processing, seamless integration and data interchange, they are also keeping an eye on the quality and compliance of the data. The shift now is toward verification of the data quality, honest assessment, and open reporting. To ensure the data submitted is clean and timely, authorities are subjecting companies to greater scrutiny, more queries and observations, and an increased number of audits and inspections. The best advice is to ensure a compliant and efficient safety system is in place.
If companies are not reporting sufficiently, the authorities might want to check how they are capturing information or determine whether they are missing information or potentially not reporting it honestly or adequately.
Undoubtedly, having a validated safety reporting solution vastly reduces the chance of an audit and inspection. Insufficient data or reports that don’t adhere to guidelines result in significantly more audits.
Learn more about ARISg and ARISj and why companies and regulatory authorities, including Health Canada, adopt these pharmacovigilance systems for global safety case reporting.

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An electronic, automated approach to drug safety and risk management is the way of the future, and Health Canada is one authority that has catapulted itself into a progressive, yet strict position to protect patients.
The agency has adopted a robust pharmacovigilance regulatory reporting system and has also laid out strict processes to better manage the reporting of serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSAR) during clinical trials, and spontaneous postmarketing adverse events.
The Health Canada requirements differ somewhat from those required by the US Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) for monitoring adverse events and medication errors. While the agency’s validations closely follow those required for the European Medicines Agency’s (EMA) Eudravigilance system, Health Canada has several additional rules that ensure that data being receive is high quality and can be easily aggregated for use in data dissemination and signal detection.
Health Canada grants a Notice of Compliance (NOC) and a drug identification number (DIN), which authorize the company to market their drug in Canada. While EMA and FDA support the messages of the ICH individual case safety reports (ICSRs) and periodic safety update reports (PSURs), Health Canada adds several other validation rules and data elements to its requirements.
These include messages such as CTICSRs, which are ICSR expedited reports from clinical trials, and DSURICSRs, which are non-expedited reports during interventional clinical trials. The agency also has separate guidance in support of expediting reporting for Canada’s Access to Medicines Regime (CAMR) and separately to expedite reporting for the Special Access Programme.
Health Canada also has its own way to assess records, checking a combination of data elements to determine if the record to be uploaded is a follow-up from the same source or a duplicate version from a new source of an existing case in the Canada Vigilance Adverse Reaction Online Database.
During the validation process for a marketing authorization holder to bring in new trading partners, the agency requests an extract of each company’s product dictionary, which is reconciled against the Health Canada’s product dictionary
Companies must also send their drug database, including approval details and dossier information, to Health Canada before they start reporting. This allows the agency to check against its drug safety system as to whether the reports being received are for valid drugs.
Simplifying Processes
Since Health Canada’s system is set up with the rules on drug safety reporting pre-configured, it’s fairly easy for the agency to check whether the data that companies send meet requirements. However, companies that are sending reports manually or that have solutions that aren’t aligned with the agency’s requirements must make sure that what they send aligns with what is required of them.
For example, patient-reported spontaneous postmarketing adverse events often lack sufficient information to accurately identify the drug, dosage, or strength. Health Canada has therefore introduced several criteria that company need to include to match the event to the right product and assist with signal detection in drug safety. These criteria include active ingredient if the product name is unknown or strength of the formulation.
Without the processes in place to automate identification of the product and simplify coding, such as medical coding software, companies face a manual and time-consuming task.
In my next blog, I’ll explore the challenges and potential ramifications of manual reporting. To learn more about streamlining processes and aligning with Health Canada, contact me and my colleagues or read about the ARISg solution.

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A common trend amongst drug safety departments in life science companies is that they’re being asked to do more with less, without compromising quality or compliance. As case volumes and complexities increase, many safety departments simply cannot survive if they continue with their current risk evaluation and mitigation strategies.

In a recent webinar, “How Safety Departments Can Overcome Resource Challenges,” industry experts including ArisGlobal’s Dr. Krishna Bahadursingh provided insights on current challenges and trends facing drug safety departments. In addition, he spoke about how drug safety systems need to evolve to manage current and future challenges.

Audience Polls

The webinar also polled attendees on some key areas including:

While “ensuring compliance” was the top challenge facing safety professionals surveyed, it does reveal how many teams are struggling to maintain the basics of compliance – and not focusing on preventing risk, data analytics or leveraging technology for automation.

A follow-on question revealed the current state – where many know the challenges they face, but have not implemented technology solutions to address those challenges:

While it appears many safety and pharmacovigilance professionals are still wrestling with basic compliance, the acknowledgment that they need to evolve is certainly there – which is where technology solutions like TotalSafety come into play.

Watch the on-demand webinar now to see how you can learn from industry experts – and how you can future-proof your processes to ensure survival in the future!

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Medical coding is a time-consuming and laborious responsibility for many pharmaceutical and biotech companies who conduct clinical trials and market their products in multiple locations around the world. Unless a centralized medical coding tool is used, inconsistencies and inefficiencies will impede the efforts to review, resolve and approve coded terms across staff, sites, trials and locations. Without consistent centralized coding, any kind of statistical analysis will deliver questionable results.

• Related Blogs: Centralized Coding in the Spotlight |  How-to Advice on Switching Your Coding Tool
• Related Whitepaper: Achieving Consistency in Clinical Coding for Periodic Reporting and Signal Detection

Are you using a coding tool/system currently?

As a necessary regulatory obligation, many biopharmaceutical companies and CROs struggle with coding medical and drug terms as quickly and efficiently as possible while still ensuring consistent and high quality coding. However, organizations are increasingly taking a centralized approach to medical coding to ensure that data is consistent to a standard that can be used across multiple departments in an organization.

Using consistent, standardized coding of terminology of safety data – from clinical trials to post-market adverse event reports — ensures reliable data analysis and reporting. This is essential in order to create an accurate safety profile and to prevent the dilution of safety signals or generation of false signals. Furthermore, having a central coding solution allows companies to leverage the capabilities in clinical as well as safety, removing inconsistencies and enabling cost savings.

agEncoder, from ArisGlobal, is a centralized coding and dictionary management software that enables efficient classification/coding and review of verbatim terms, and seamlessly integrates with an already available 3rd party EDC clinical or safety database. This allows organizations to use agEncoder as a “stand alone” application or as an integrated product for consistent coding and improved coding quality. Available on premise or as a hosted solution on the SaaS platform, agEncoder ensures a higher “hit rate” of auto-coding with a simplified handling of different versions of dictionaries.

Click to enlarge

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Experts Convene to Discuss How Medical Information Professionals Can Ensure Success Amidst Increasing Challenges

Medical information is key to the successful marketing and adoption of any drug. Unfortunately, many pharmaceutical companies have silo’d, disconnected systems and expend enormous amounts of resources generating and disseminating medical information through many channels, often resulting in increased costs and higher risk.

To help address these challenges, attend the upcoming webinar as experts including Simon Sparkes, ArisGlobal Executive Vice President – Product Strategy, will provide insights from his 28 year’s expertise with medical information systems and the business leader for ArisGlobal’s world-renown medical communications solutions

Register today to learn about the ways that medical information professionals can succeed – and learn what your peers are doing with their medical communications systems to ensure success.

Additionally, we’ll preview the latest release of our medical communications platform that offers more integration and automation – including mobile – than ever before!
Register for the webinar today – Tuesday, Dec 06 at 3PM London / 10AM New York!

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ArisGlobal’s medical information platform, including our cloud-based adverse event reporting software, is the only ‘all-in-one’ solution to improve efficiency and productivity

Today’s Medical Information (MI) teams face enormous challenges in meeting both heightened regulatory requirements and the demands of healthcare professionals, patients and key stakeholders for immediate access to secure information.

Common Challenges for Medical Information Service Delivery

While the challenges vary, some of the most common areas are:

• Meeting PV obligations and ensuring global compliance
• Being able to provide actionable insights
• Providing up-to-date, consistent and accurate medical information globally
• Addressing data privacy regulations
• Managing multi-channel communication with healthcare professionals, patients, sales/MSLs and medical affairs
• Integrating medical information systems seamlessly with other systems

Meeting these demands will support the effective use of a product and the marketing of any drug since pharmaceutical companies spend enormous resources generating and disseminating medical information through many channels.

Today’s medical information systems need to leverage the latest innovations in technology in order to provide:

• An improved user experience
• Enhanced operational efficiencies
• Actionable insights
• Compliance for MI, PV and PQC

The ArisGlobal® MedComm™ unified medical communications software (.pdf) is transforming and streamlining these crucial areas for greater accuracy, consistency, cost savings and compliance, successfully managing all inbound and outbound post-approval communications for improved compliance and consistency while reducing risk of information errors – one of the most comprehensive medical information systems on the market.

Learn more about the attributes of a high performing MI teams by downloading the whitepaper: Empowering Global Medical Information Teams with Software Solutions

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By Danilo Pavlovic
As both a conference attendee and ArisGlobal representative in our booth on the show floor at the recent Partnerships in Clinical Trials Europe, I had plenty of opportunity to sit in on sessions, talk to industry colleagues and meet with attendees. From show-floor chat on the societal impact Brexit and U.S. President-elect Trump will have, to sessions on how patient centricity and wearables are changing trials for the better, these and other topics were addressed over our two days together, and will undoubtedly have some varying impact on life sciences over the coming years.

However, as it relates to an organization’s technology infrastructure, three core questions continue to bring visitors to the ArisGlobal booth at any show we attend. How can I better manage increased trial complexity? How can I accelerate trial timelines? How can ArisGlobal’s eClinical solutions meet my company’s specific business needs?

For small-to-midsize contract research organizations (CROs)

Our Agile CRO Partner Program and its “Pay-As-You-Grow” pricing plan sparked a lot of interest. This partner program is designed specifically to provide small-to-midsize CROs a low cost of entry to compete effectively for outsourcing opportunities. One real-world example I’ll quickly share is Syngene International Limited, who leveraged this plan to move away an elementary paper-based solution to agCapture, our electronic data capture software (EDC).

As this CRO explained, “Flexibility and pricing were both very important factors. This was one of the key reasons why the bigger companies were not considered. Bigger software firms would never customize to our requirements.” Read the full Syngene story here.

For the pharmaceutical companies and larger CROs

The ability to plan, track and control all tasks and activities related to their ongoing clinical trials was the prominent challenge that got us involved in some great conversations. Tired of CTMS solutions that have fallen short on meeting their needs, these sponsors were genuinely interested to learn more about agClinical’s ability to provide centralized, end-to-end management of trial activity. That, and the fact that agClinical comes with an integrated eTMF and pre-built connectors to third-party systems, such as EDC, were among the clinical trial management software capabilities and features that definitely got their attention.

Ultimately, each company we talk to – whether at our booth on an exhibit floor or over the phone – has common but slightly unique needs and requirements that need to be resolved. For me and others at ArisGlobal, each opportunity to collaboratively work with a customer to successfully meet their challenges brings a level of deep professional satisfaction that is hard to surpass

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Medical information is key to the successful marketing and adoption of any drug. Unfortunately, many pharmaceutical companies have silo’d, disconnected systems and expend enormous amounts of resources generating and disseminating medical information through many channels, often resulting in increased costs and higher risk.

In a recent webinar, “Five Keys to Success for the Medical Information Professional,” Simon Sparkes, business leader for ArisGlobal’s world-renown medical communications solutions, provided insights based on his 28 year’s expertise within the pharmaceutical industry. In addition, he spoke about how medical information systems integration and automation can be effectively achieved, streamlining many of today’s processes.

During the webinar, attendees were polled on a key topic:

While “managing multi-channel communication” was the top challenge facing medical information professionals, it does reveal that “ensuring global compliance” is also a primary concern.

Watch the on-demand webinar now to see how you can learn from industry experts – and how you can future-proof your processes to ensure survival in the future.

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