5 Life Sciences Technology Strategy Considerations for 2015

  1. Have you assembled the appropriate project team to implement a life sciences application?

The nature of projects and outsourcing today is composed of complex global projects managed by virtual teams and project variance. Outsourcing strategies and project variance leads to cost variation within a budget which usually is unaccounted for. Projects involving the implementation of life sciences applications can fail for multiple reasons – however a lack of user requirements and budget mismanagement should not be any of those reasons.

A good implementation team is usually a multidisciplinary team that adopts a risk-based approach to identifying obstacles and establishing measures that will mitigate challenges and foresee the participation of the client’s key users from the first steps of system implementation.  The key users usually collaborate with the validation team in the definition of general/regulatory user requirements, but their involvement starts at the very beginning of the project. In order to include the key/business users at this stage, the IT Project Manager should include a Business Analyst in the project team.

By using this approach, key users can deepen their understanding of how the system works and if it fits their organizational structure, processes and procedures. Consider a multidisciplinary team of business analysts, project managers qualified and specific to the system being implemented and a Computer System Validation expert (see why below!).

  1. Are you leveraging cloud-based solutions for important clinical systems?

We have stated the data before: It has been estimated that cloud computing techniques could lead to a 30 percent increase in speed to trial for clinical work, resulting in up to $400 million USD in savings.

The benefits of implementing a cloud-based solution for electronic data capture are endless: no more IT infrastructure investments, better data quality and global study management, software reusability and more secure data transfers. More importantly, cloud-based systems allow access to real time data which supports better discrepancy management, faster data cleaning and ad hoc reporting.

Cloud-based SaaS systems are ideal and cost-effective for pharmacovigilance as well by implementing a system accessible through the Internet with minimal IT effort. In this scenario, the application can be deployed using the standard validation configuration and then be customized to meet customer needs. The Cloud eliminates the need for hardware and software installation and allows clinical applications to be accessed through a web browser with personal credentials, eliminating the need for IT infrastructure such as data centers.

  1. What clinical data visualization solutions so you have in place?

Modern communication technologyIs your company looking to have access to clinical data in real time? Is Risk Based Monitoring part of your upcoming clinical trial strategy? Data Visualization tools make it possible to collect clinical and safety data from multiple sources and display the data in a structured format for the study team. The analysis team has the ability to drill-down data and click-through multiple levels of details.

Perhaps the biggest benefit is the ability to see and analyze safety data metrics from multiple sources in real-time. Real-time alerting features can notify the study team when problems arise, for example when adverse events are entered. Real-time data results allow decision-makers to identify and fix underperforming sites and make crucial decisions.

Business Intelligence tools are the best technology option for Risk-Based Monitoring. They allow for data retrieval, report development from different data sources, report delivery and cloud-based technology. Web-based applications can be accessed from various devices including PC/laptops, smartphones and tablets.

  1. Are all of your systems up-to-date and in compliance with industry standards? Are they really?

As mentioned above, every successful life sciences project team should have a Computer System Validation and Risk Management expert. Computer system validation in the pharmaceutical industry is applied from discovery through to manufacturing and supply. Between 40-60% of software defects can be traced back to errors made during the requirements stage. The costs of IT quality can be an investment: from documented planning and prototyping to review and inspection and test execution. However, the costs associated with poor quality normally outweigh the costs associated with good quality.

Defect correction, including diagnosis and bug fixing, can produce enormous costs for companies. More importantly, external failure can cause huge losses for a company. Operational defects can lead to lost productivity and lost sales. On a more serious note, it can lead to a delay in a new drug approval or even regulatory fines.

Are all of your clinical systems up to date with the latest security patches? Discontinued software versions should be considered a high security risk for critical IT components and should be mitigated by upgrading to supported versions or migrating to newer solutions in other platforms.

  1. Is your company prepared for Disaster Recovery and Business Continuity?

In an increasingly technology-dependent world, is your company prepared for a power failure? Cyber attacks? Disaster Recovery and Business Continuity is crucial for life sciences companies today. Sponsors should know if their IT provider has a plan in place – after all, consider the quantifiable losses if your IT infrastructure shut down for an hour, a day or even more? Could you go on conducting “business as usual”=

A good Disaster Recovery plan starts with analyzing the risks. Once you have determined the priorities, the most important analyses will be the RPO (Recovery Point Objectives) and the RTO (Recovery Time Objectives). The RPO will establish how far back services will have to go to find recoverable data, and the RTO will determine how much time is needed for recovery. The Disaster Recovery plan must then be maintained through proper documentation and system validation.

Ask the Experts: Computer System Considerations for Pharmacovigilance Data Migration

Adaptive Trial DesignWhen it comes to safety systems, pharmacovigilance professionals must take into consideration the guidelines and legislation laid out my regulatory agencies. Computer systems used to manage safety data are subject to rigorous validation testing to determine if they are suitable to manage safety data in the clinical environment.

Last month, ARITHMOS hosted the second edition of Pharmacovigilance Day in Milan, a seminar which invites pharmacovigilance professionals to meet and discuss the industry’s most pressing issues. This year, a senior PhV Inspector from the Italian Pharmaceutical Association (AIFA) presented his considerations on computerized systems and Inspection-Readiness especially in terms of data migration and the PSMF.

According to the Good Vigilance Practices (GVP) applied in Europe, “facilities and equipment which are critical for the conduct of pharmacovigilance should be subject to appropriate checks, qualification and/or validation activities to prove their suitability for the intended purpose. There should be processes in place to keep awareness of the valid terminologies in their valid versions to keep the IT systems up-to-date accordingly”.

This is of utmost importance in the pharmacovigilance field, especially when it pertains to the transfer of safety data from outdated or legacy systems.

What does this mean for the migration of pharmacovigilance data?

More specifically, GVP Module VI addresses the need for a quality management system to ensure compliance with standards and documentation including data collection, transfer and management.

Therefore, there is a need to establish which processes will be used in every step of data migration and who will be involved in the data transfer and their role. Next, the checks that will be carried out after migration next to be defined to guarantee data integrity and completeness in the database. Lastly, a documentation and archiving process needs to be defined.

A quality management process needs to be in place to keep track of the activities done before, during and after the data transfer to ensure that the transfer to the new database is secure and complete and that the processes used did not result in the loss of safety data.

Verifying data migration is essential when:

  • There a new safety database is implemented
  • The acquisition of a new company or the merging of two companies

As our expert points out, data migration is necessary because:

  • Cumulative data in ICSRs are requested for the analysis of signals and for a risk/benefit analysis
  • PSURs, where foreseen, must contain cumulative “summary tabulations” of adverse reactions
  • Regulatory agencies can request cumulative reviews for types of specific events
  • Occasionally follow up information can be requested for previous signaled cases

Additional Considerations for the PSMF

Besides safety databases, the PSMF must report any electronic system that collects, registers and reports safety information including medical information systems, data banks or any other system in clinical trials that collects safety data.

Common deviations for computerized systems include the absence of a disaster recovery and business continuity plan, no reconciliation between the pharmacovigilance database and other department databases and the failure to enter all AEs into the PhV database.

ARITHMOS recommends a full business and technical analysis of pharmacovigilance needs before proceeding with data migration projects. Our multidisciplinary team of business analysts, life science application specialists, pharmacovigilance system and process experts and computer system validation experts can prepare a proper user requirement analysis and a risk management plan to guide companies through data migration projects to guarantee compliance with regulatory standards.

5 Reasons Clinical Data Visualization Matters for Pharmacovigilance

ARITHMOSModern communication technology has recently reported that according to an ongoing survey on pharmacovigilance challenges, the management of vast amounts of safety data is an uphill battle for Sponsors.

Data Visualization, which is the concept that data can be structured and viewed through visual representation such as charts and graphs, can facilitate safety data analysis. A strategy of data collection and business intelligence tools can allow Sponsors to make sense of safety data collected in order to make important, and even on-the-go, decisions.

Here are five reasons why Sponsors should be considering clinical data visualization tools for the effective pharmacovigilance management.

1. Access to Data from Multiple Sources

As clinical trials today are often complex in nature and can be conducted on a global scale, data can be spread across multiple sources including databases, eClinical systems (EDC, CTMS, etc) or even across multiple vendors. Data Visualization tools now make it possible to collect safety data from multiple sources and display the data in a structured format for the pharmacovigilance team. The analysis team has the ability to drill-down data and click-through multiple levels of details.

2. No technology or assistance required

Data Visualization tools today are generally based in cloud computing mode. That makes it easier for Sponsors to implement these tools without the technology hassle of HTML or plug-ins. As a user, this means a company can access services from anywhere via the Internet without hardware/software provisions, installing service applications and maintaining applications.

3. Ad-Hoc Reporting & Dashboards

The customization of data visualization tools means that clinical trial leaders can look past the “big picture” and see the specific metrics that matter to their studies. A customizable dashboard allows the pharmacovigilance team to create ad hoc reporting tools for metrics related to safety data and patient management.

4. Real-Time Results

Perhaps the biggest benefit to data visualization is the ability to see and analyze safety data metrics from multiple sources in real-time. Real-time alerting features can notify the study team when problems arise, for example when adverse events are entered. Real-time data results allow decision-makers to identify and fix underperforming sites and make crucial decisions.

Cloud-based solutions allow business intelligence tools to be integrated with eClinical tools such as pharmacovigilance systems. This means that pharmacovigilance leaders can have safety data metrics available on their smartphone or tablet wherever they are.

5. Eliminate the Burden; Consider Business Process Services (BPS) Partnerships

Data Visualization in cloud computing mode is a worthwhile investment as it eliminates the burden on the pharmacovigilance team to maintain software systems. The return on investment from the implementation of data visualization tools is the amount of time saved by being able to access and analyze safety data immediately and using that data to identify and fix problems.

If Sponsors consider a BPS approach – in which companies engage in licensing contracts with a third party vendor for back-office functions or front-office activities – they can have access to an expert IT infrastructure without the burden and investment. For example, ARITHMOS is part of the Oracle BPS partnership which allows the company to use and understand Oracle applications and offer an optimum value package to clients.

ARITHMOS can install the Oracle Business Intelligence application and integrate it with pharmacovigilance systems for real-time reporting. Oracle BI provides the BI Publisher “app” for iPhone and iPad which is available for free download in the Apple iTunes store. The installation of Oracle BI Mobile to the iPhone/iPad is a straightforward configuration to the BI Publisher. Communication is secure through HTTPS, and users have personal log-in information. Using Oracle BI as a data visualization tools covers all the core components of data visualization: web-based in the cloud, access to multiple data sources, data in real-time, specific safety data metrics and personalized dashboards and ad-hoc reporting.

The Biggest Challenge in Pharmacovigilance Today Is….

pharmacovigilance_safety_dataIn an ongoing survey analyzing pharmacovigilance trends, ARITHMOS asked pharmacovigilance and clinical operations professions what they think the biggest challenge facing the field is. Are pharmacovigilance practitioners overly concerned with satisfying regulatory requirements or accurate signal detection?

According to ARITHMOS’ survey, which has been active worldwide for the past 2 months via our website and social media channels, respondents cited costs associated with implementing and maintaining a PhV system and managing vast amount of safety data as the biggest challenges in the industry.

Costs are always a primary concern in the life sciences industry as regulatory requirements become more burdensome while budgets tighten. System implementation and maintenance requires laborious collaboration with IT and business analysts, licensing concerns and regular maintenance checks and upgrades.

ARITHMOS has some tips on managing these difficult pharmacovigilance challenges:

System Implementation & Maintenance

Investing in a pharmacovigilance system or migrating to a modern system can be a huge investment for many companies. Ensuring a high Return on Investment from your system begins in the planning phase. Make sure your system provider has a multidisciplinary team of business analysts, life science application specialists and computer system validation experts in order to define user requirements and prepare a risk management plan.

A cost-effective solution is to implement a cloud-based pharmacovigilance system accessible through the Internet with minimal IT effort. In this scenario, the application can be deployed using the standard validation configuration and then be customized to meet customer needs. Computer systems can cost a company up to $2 million USD plus the additional costs for experts to install and maintain these systems. The Cloud eliminates the need for hardware and software installation and allows clinical applications to be accessed through a web browser with personal credentials. Additionally, a cloud computing solution eliminates the need for IT infrastructure such as data centers, significantly reducing costs.

ARITHMOS has also established the Oracle Argus Consortium Initiative for Oracle Argus Safety Version 7. The fundamental idea behind the consortium is that customers take advantage of up to 20% cost savings due to the sharing of set-up activities, validation documentation and deliverables. The Oracle Argus system would be released to the customer with a standard configuration which is shared among multiple end users.

pharmacovigilance_cloudManaging Vast Amounts of Safety Data

Again, ARITHMOS stresses the benefits of cloud technology for managing vast amounts of data. Sponsors can organize multi-language, global safety data into a single database which is particularly beneficial for efficient signal detection, safety reports and reporting as well as data analysis.

In order to successfully manage data, ARITHMOS recommends automating signal detection by implementing a reporting tool (for example, SAS) in order to pull and analyze data. The identification of signal criteria and the implementation of standardized programs automates the signal detection process.

However, a key aspect of safety data management is clinical data visualization and ad hoc reporting. The return on investment from the implementation of data visualization tools is the amount of time saved by being able to access and analyze data immediately and using data to identify and fix problems. Arithmos can integrate Business Intelligence tools with Data Visualization tools on handheld devices such as smartphones and tablets for safety data on the go. With the changing pharmacovigilance legislation, real time safety data is crucial. Arithmos has data visualization solutions for clinical safety reporting from the best pharmacovigilance databases and systems.

 

In Copenhagen, Technology is the Focus of Nordic Life Sciences Events

Next week, ARITHMOS is in Copenhagen to sponsor to life sciences events that focus on evolving trends in the clinical trials sector – pharmacovigilance and Risk-Based Monitoring. Technology takes center stage when looking to implement solutions that can ensure data quality, improve efficiency and cut costs.

Nordic Pharmacovigilance Day
7th of October – Carlsberg Museum & Business Centre in Copenhagen, Denmark

????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????Pharmacovigilance Day focuses on “designing an efficient pharmacovigilance system” and how the use of electronic systems can help companies achieve the effective safety system required by law, especially under the new GVP guidelines.

ARITHMOS has pointed out before that the system you choose should be compliant with global adverse event reporting standards as well as with standards of main regulatory bodies. For example, the EU has relased good pharmacovigilance practice guidelines (GVP) which focuses on “proactive and proportionate risk management”, higher quality of safety data and “strengthened transparency”.

  • Does the system have technologically advanced reporting tools?
  • Is the system intuitive?
  • Is the system available in the cloud?
  • Does the system have the appropriate coding functions?
  • Who will take care of the hosting, validation and maintenance?

Speaking of pharmacovigilance in the cloud, Pharmacovigilance applications should be accessed through the Internet with minimal IT effort through web browers with no installation required on a PC. Another option is to publish the application in Citrix with only a plugin to install. A cloud computing and SaaS solution is a valuable technological trend for efficient application delivery. The burden on the customer is reduced in terms of hosting and maintenance and the default configuration meets standard business processes. This solution is flexible to changing business and operational needs and guarantees an efficient and cost-effective solution.

 

Nordic ePharma Day
8th of October – Carlsberg Museum & Business Centre in Copenhagen, Denmark

At Nordic ePharma Day, the topic on the table is Risk-Based Monitoring the role of technology in supporting the transition from the “common” to the Risk Based Monitoring.

Centralized Monitoring has been proposed as a new, more efficient and cost‐effective approach to on‐site visits. A CSM approach performs data quality checks on all trial centers at the subject and site level. Statisticians can then analyze the data in real time to identify sites that need further investigation due to unusual data patterns. In a CSM strategy, many discrepancies can be improved by implementing cloud‐based technology solutions. Clinical Data Visualization and analytical business intelligence tools should be considered to query the EDC database and design reports for the main personnel involved in the trial review that assess site activity for quick analysis and decision‐making. Tools available today are generally cloud‐based which means Sponsors avoid the technology hassle of HTML or plug‐ins and enjoy the convenience of data “on the go”.

ARITHMOS is pleased to sponsor both of these Nordic Life Sciences events and promote the role of technology is these life sciences trends. If you are interested in attending these events, please visit the event websites. If you have a need for technology solutions in pharmacovigilance or Risk-Based Monitoring, please contact ARITHMOS for an RFP.

ARITHMOS Launches Survey on Pharmacovigilance Market & Challenges

In an effort to better understand the complicated, yet growing, pharmacovigilance market, ARITHMOS has launched a survey on present challenges facing pharmacovigilance professionals.

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This market survey aims to meet two key objectives:

– Understand the most pressing issues pharmacovigilance professionals face in terms of safety systems, inspection readiness and reporting
– Understand expectations in terms of financial investment in safety systems and what constitutes a good Return on Investment

The ARITHMOS pharmacovigilance survey is intended for market research purposes only and should take approximately 10-15 minutes to complete.

TAKE THE ARITHMOS PHARMACOVIGILANCE SURVEY

Pharmacovigilance Best Practices Part II: Consortium Initiative

In Part II of ARITHMOS‘ article series on pharmacovigilance best practices, we address the need of project implementation and maintenance by introducing the Consortium initiative which helps companies significantly reduce costs while receiving expert advice from cross-functional teams.

Two hands touch screen of tablet with medical icons. VectorIn order to facilitate the implementation, production and maintenance phases of a pharmacovigilance system migration project, ARITHMOS has introduced a consortium for the provision of Oracle Argus Safety Version 7. The fundamental idea behind the consortium is that customers take advantage of lower costs due to the sharing of set-up activities, validation documentation and deliverables. The Oracle Argus system would be released to the customer with a standard configuration which is shared among multiple end users.

The concept of sharing implementation activities guarantees at least a 20% reduction in costs for Consortium subscribers. The benefits to joining are:

  • Access to experienced Project/Account Manager during set-up and production
  • Get a standard configuration built on best standard practices and experience
  • Have the PhV application hosted in a certified Data Center with backup/recovery processes in place
  • Compliance and regulatory expertise and support during inspections
  • Use of International Standards (GAMP5) and Internal QMS
  • Multidisciplinary team covering all validation aspects (Business analysts, IT experts, CSV specialists)

Why is the Consortium an ideal solution for pharmacovigilance departments?

Step 1: Oracle Argus Safety Version 7 is an ideal solution for managing global workflow while providing case reports and instant safety data reports and analysis. It is an up-to-date pharmacovigilance system that meets all the requirements of computerized systems in the GVP environment. As an Oracle Business Processing Services (BPS) provider, ARITHMOS provides the Oracle Argus Safety license with payment based on cases entered in a defined time period with no annual maintenance fee.

Step 2: The Consortium initiative also covers compliance and Computer System Validation aspects of pharmacovigilance through a Quality by Design approach. As a member of the Consortium, a cross-functional team of validation experts are available to make sure the system is maintained properly through periodic review and change control.

Consortium ROI: Consortium membership guarantees cost reduction through the sharing of implementation activities and documentation. However, the real Return on Investment comes from access to validation experts, advice and feedback from other Consortium members and access to “My Oracle”, which is Oracle’s official web portal for the support of its applications – guaranteeing a smooth, compliant and risk free pharmacovigilance process.

The Consortium is a yearly initiative with limited subscriptions available. For more information on a pharmacovigilance system migration project and Consortium membership, contact ARITHMOS at info@arithmostech.com.