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.

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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.

Automation and Traceability Tech Tools for CDISC Mapping Projects

male doctor holding tablet pc with medical appMany pharmaceutical and biotechology companies use CDISC standards when creating databases for new clinical studies. The FDA has recently stated that it “will develop guidance for the industry on the use of CDISC data standards for the electronic submission of study data in applications”.

Adopting and implementing CDISC standards can increase drug development analysis costs. However, identifying the right process for implementation and choosing the appropriate technology can reduce the costs of adopting these standards, making it a very worthwhile investment. ARITHMOS looks at some technology considerations.

Automating Tools to Ensure Consistency

Establishing the correct workflow to manage this CDISC implementation process is the first key step. Sponsors should look at automation tools to create standard data sets to ensure speed and consistency. There are commonly available software applications – for example, SAS can be used to convert Excel data sets and apply metadata attributes to the CDISC domains.

Data Repositories for Information Management and Cost Reduction

Implementing CDISC standards means adopting technologies that can manage the flow of data and information. Keeping clinical data in multiple repositories can create a complex management process and is often prone to error. Managing multiple repositories can mean spending more time on vendor management.

Setting up a central database for all data – whether from a laboratory, a CRF or an ePRO device – to be stored in one place, allows for an easier mapping process. With a centralized hosting system, the process is linear and traceability is under control. A centralized system also provides easy data transfer to the Sponsor, Regulatory Authority or Purchaser.

Benefits to Hosted and Centralized Storage:

  • Cost: Avoid paying multiple CROs or technology providers to set up a global library, program macros and perform validation checks
  • Efficiency and Time: When the team is already familiar with Sponsor requirements the review cycle reduces. Training and HelpDesk costs also reduce.
  • Quality: Measurement scales, design features, outputs and summaries all become standardized.
  • Access to Data: Reporting and access to data becomes much more straightforward. Central web access can be used by sponsors to obtain important safety information, efficacy data and study progress reports.
  • Information in a single point of storage/database
  • One audit trail data source
  • Same location for study data and derived data
  • Traceability is possible from beginning to product submission and market authorization
  • One portal for real-time reports
  • Reporting availability on devices: laptops, tablets, smartphones, etc.

downloadClinical Data Visualization to support CDISC

Clinical Data Visualization and Business Intelligence analytics can support CDISC mapping projects if data is spread across multiple databases and sources. These tools can collect the data from multiple or disparate databases and display the data in a structured format.

The customization of data visualization tools means that clinical trial leaders can see specific metrics that matter to their study as well as see data in real time and “on the go”.

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.

 

Enhancing Risk-Based Monitoring with Data Visualization & Analytics

In anticipation of German ePharma Day on the 26th of June which is focused on “Risk-Based Monitoring in Clinical Trials”, ARITHMOS is looking at how to implement data visualization and analytics tools and strategics to enhance risk-based monitoring.

StatisticsRBM combines on-site monitoring with centralized remote monitoring supported by the study biometrics team (e.g. Data Managers, Statisticians, etc.). The RBM strategy should be considered in the protocol design stage, and therefore Data Managers can include RBM in the Data Management Plan and Statisticians can plan accordingly for their analyses.

The key factors in RBM are:

  • Patient Safety
  • Data quality/integrity
  • Protocol adherence/deviations
  • Monitoring time/cost efficiency

Therefore, monitoring is not only the responsibility of the Monitor, it becomes a cross-functional activity shared among different functions who handle data. Successfully managing a Risk-Based Monitoring approach requires metrics and reports tailored according to risk indicators as well as reporting, analysis and visualization technology solutions.

Executing RBM

Centralized/off-site monitoring can be supported by data taken from:

  • EDC systems
  • CTMS
  • IWRS/IVRS
  • Safety databases
  • Study documentation

RBM diagram

In a typical scenario, data and reports are taken individually from various systems. It makes it difficult to analyze the data for critical key factors and protocol adherence and to then make timely decisions according to the risk mitigation plan.

A solution allows those involved in RBM to create the information they need, share that information and analyze it in order to make crucial decisions such as when to trigger a monitoring visit when data comes in above or below thresholds or highlighting non-performing sites at the earliest time.

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. It is important to note that these tools are also visualization and analytics tools which have additional features to support RBM. Some distinct features for RBM include:

  • Birthdays and Initials: match subjects based on birthdates or initials to identify subjects that enroll in study more than once
  • Perfect Schedule Attendance: Perfect scheduling based on expected study visits may be too good to be true.
  • Duplicate Records: identifying a set of test values that are repeated within or across subjects can indicate a problem.

In cases of IMP studies, data are available from previous studies, and often times this data is not used. Business Intelligence tools can pull data from the data warehouse in order to complete risk assessments and define critical data and processes.

Data, reports and analysis are key factors in an efficient application or RBM. A Business Intelligence solution can support ongoing monitoring through ad-hoc reporting, analysis capabilities, visualization, real-time data availability and information sharing. These tools can also support new studies by accessing historical data, better identifying risk factors and thresholds and better designing study protocols.

If you are interested in technology solutions such as Electronic Data Capture and Data Visualization tools for your Risk-Based Monitoring strategy, please contact us at info@arithmostech.com.

Technology Considerations for Successful Risk-Based Monitoring

ARITHMOS is participating in this year’s ePharma Day series across Europe which highlights the importance of risk-based monitoring for clinical trial operational efficiency. Technology plays an important role in successful risk-based monitoring practices in order to conduct 100% source data validation (SDV) at every investigational site. How can technology transition from “common” processes to a RBM approach?

Image_Feb_VitalSync500-466x270Risk-based monitoring (RBM) of clinical trials is an approach that combines on-site monitoring along with centralized remote monitoring by coordinating centers. Based on risk assessments about how the clinical information is captured and protocol is designed, risk-based monitoring activities can be proactively supported by the usage of reporting tools.

The FDA and EMA issue guidelines encourage the use of electronic systems and strategies to identify and prevent risk factors for the quality of data, patient safety and trial integrity.

Electronic Data Capture is an essential part of a RBM technology strategy since it captures data in real time. EDC allows Investigators to capture and monitor site activity remotely, however EDC only captures part of the picture. The EDC system itself captures data and determines which data needs to be verified and analyzed. Although most EDC systems provide built-in reports to support data management activities, other metrics and information which are needed to verify the risk-based approach are not provided to final users. Key information that might not be provided by the EDC system include:

  • Site information to get recruitment activities at the site level
  • Subject status: information about the screening status, screen failure, enrollment etc
  • eCRF status: how many eCRFs have been completed and/or verified?

A risk-based monitoring approach technology strategy should also include analytical business intelligence tools. By using a business intelligence tool to query the EDC database, reports can be designed depending on the targeted audience involved in the trial review including project and data managers, site staff, clinical monitors and safety staff. Reports with centralized monitoring metrics that assess site activity, including recruitment, CRF completion and DCF resolution, can be easily made available for quick analysis and decision-making. Clinical data visualization and analysis is especially important to aggregate data across multiple systems and even multiple studies.

Data Visualization tools now make it possible to collect data from multiple sources, even disparate databases, and display the data in a structured format for all members of the clinical team. An added value is the ability to drill-down data and click-through multiple levels of details to aid in analysis. 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”.

The intangible benefits of analytical tools for risk-based monitoring are apparent, especially the ability to create ad hoc reports on site information, safety and efficacy, drug supply and patient management. The return on investment from the implementation of these tools is the amount of time saved by being able to access and analyze data immediately and using the data to identify and fix problems.

ARITHMOS’ Gianluigi Albertini will be presenting at the ePharma Day series on “Business Intelligence: Analysis of metrics and effective technology supporting Risk based monitoring in clinical trials”. ePharma Day 2014 focuses on Risk Based Monitoring in Clinical Trials and discusses the importance of developing an overall risk assessment plan, better tools for a holistic and dynamic oversight of site activity and the critical items Auditors will consider for guaranteeing GCP compliance. The first two ePharma Day events are scheduled for 27th of May in Milan, Italy and 26th of June in Frankfurt, Germany.  

 

The Role of Technology in the European Union’s Data Transparency Law

l_1171_ema-transparencyLast week, the European Union took a significant step in advancing the European Medicine Agency’s initiative on clinical trial data transparency. The EU approved a draft law that will require Sponsors to publish full clinical trial summaries in an EU database accessible to the public upon marketing authorization. This news comes one month after the EMA published a summary of a Risk Management Plan (RMP) for the first time for a newly authorized medicine. 

The EU draft legislation states that, “in a clinical trial the rights, safety, dignity and well-being of subjects should be protected and data generated should be reliable and robust”. ARITHMOS looks at how technology will play a greater role in the data transparency initiative.

Clinical Data Visualization will perhaps be the most important technological component for Sponsors conducting trials in Europe who need to make more informed decisions and make sense of clinical data which could eventually be shared publicly. Conducting a trial generally leads to data being spread across multiple databases including EDC, CTMS, ePRO, safety databases, etc and if a centralized biometrics approach was not employed, such databases can be spread across multiple vendors and countries.

main_image_careersData Visualization tools facilitate drill-down and click-through to multiple levels of detail, allowing for the analysis of specific subsets and sub-populations. Customizable dashboards allow the clinical team to create ad hoc reports on site performance, data quality, safety and efficacy, drug supply, patient management etc. Using data visualization tools, clinical leaders can see information that is beyond the capability of the CTMS report set.

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.

What solutions are available for clinical data visualization?

ARITHMOS can facilitate the selection of data visualization tools by offering a variety of solutions for managing clinical trial metrics – especially cloud-based solutions that are available right on your smartphone or tablet.

ARITHMOS has partnered with some of the best business intelligence and data visualization providers to allow Sponsors to benchmark studies and track progress as well as understand Key Performance Indicators. ARITHMOS can also integrate Business Intelligence tools with Data Visualization tools on your handheld device.

With regards to pharmacovigilance and safety data, real time safety data is crucial. ARITHMOS offers cloud-based data visualization solutions for clinical safety reporting from the best pharmacovigilance systems and databases.

Why should clinical trial Sponsors conducting trials in Europe be considering technology solutions?

The EU draft law on data transparency is set to go into effect in 2016 and Sponsors can face heavy fines if they do not comply. Implementing technology solutions such as centralized storage, cloud-based clinical data visualization tools and real-time clinical safety reporting tools will allow Sponsors to prepare their data not only in a transparent way, but also in a traceable way for regulatory authorities. Being able to make real-time decisions based on readily available data will save Sponsors time and inevitably cut costs.