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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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.

 

The 3 C’s of EDC System Selection: Configurability, Cost-Effectiveness, Cloud

doctor holding smartphone with medical appWhen it comes to selecting an EDC vendor, Sponsors usually have different drivers that influence their decision: the intuitiveness and operational efficiency of the system, system quality and technical support and, of course, budget. ARITHMOS has been running a series of market research analyses – including surveys and focus groups – over the last few months to determine what clinical trial professionals consider the essential in an EDC system and if cost and quality are really a paradoxical dream when it comes to selecting an EDC system or if there really is a way to have both.

When it comes to a life sciences application such as an EDC system, most companies need the following: a configurable system able that is cost-effective in terms of function and management and in cloud computing mode.

If we look at these three factors individually, we’ll see how this type of EDC system can meet both operational and budget requirements.

Configurability

The concept of configurability applies to both the operational effectiveness of an EDC system and the overall impact on the study budget.

Through our market research, we found that many clinical trial sponsors value configurability in an EDC system to allow them to implement the features useful to a particular study. A customizable Life Sciences application can be a middle ground between COTS (Commercial Off-the-Shelf) software and custom software. COTS can have operational and financial drawbacks such as too many or not enough functions, high licensing costs and costly support services. Since not all study characteristics and budgets are the same, configurability allows:

  • Paying for functions needed and not paying for those not applicable to your study
  • Ability to reuse the application with slight modifications
  • Reuse of documentation to reduce costs
  • Training effort reduced due to high usability
  • Sponsor and site personnel use the same application for different projects

Sponsors can attest to the fact that no matter how prepared one is in the beginning of a study, there are always little modifications to make as the study goes on. The added value of configurability is the ability to customize solutions and make modifications without impacting the data already collected and not having to revalidate.

Cost-Effectiveness

An EDC system can come at low budget prices with baseline technology and functions. However, Sponsors are now requiring cost-effective solutions “without the bells and whistles”. Sponsors want the option of having a basic system with principal functions and pay for additional features if and when necessary. This gives the Sponsor full autonomy to manage his/her budget. Additionally, clinical trial personnel should be able to build a study and manage study data independently through an intuitive, user-friendly system.

Cloud

Lastly, sponsors are now looking for EDC systems in Software as a Service (SaaS) cloud computing mode. The advantages are clear: no hardware/software installation or IT infrastructure investment, faster trials, more efficient data management and better data quality and better global study organization.

To reiterate the first point on configurability, cloud-based solutions come with a great deal of flexibility: allowing reuse of the application, reduced training efforts and ease of managing study personnel credentials. Cloud-based solutions also allow for customizable, real-time reporting tools that can be integrated with devices such as smartphones and tablets promising accurate, up-to-date data anytime, anywhere.

How does this affect your budget? Reports have demonstrated that cloud-based EDC can speed up clinical trials by up to 30% which can lead to around $400 million USD in cost savings. You can also factor out computer system installation and maintenance which can cost companies up to $2 million USD plus additional costs for technical assistance.

ARITHMOS and Symphony EDC

This week, ARITHMOS announced a roadmap for the development of Symphony EDC, Software as a Service (SaaS) intuitive electronic data capture solution which contains the basic functions of an EDC and also allows for easy study build and management without needing external support services. This allows Sponsors to meet strict budget requirements for any kind of study.

See why Symphony EDC is also a configurable system able to coordinate various tasks, functions and documents in cloud computing mode: ARITHMOS Announces Roadmap for Symphony EDC System

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Cloud-Based EDC Part II: 5 Tips for Successful Cloud Implementation

photodune-5055010-cloud-computing-sIn Part I of our blog on cloud-based EDC, we discussed reasons why companies conducting clinical trials should consider a cloud-based approach to electronic data capture. Not only can a cloud-based solution speed up a clinical trial (reports have demonstrated up to 30%), but it can also result in considerable cost savings (to the tune of up to $400 million USD in some cases).

So, if your company is now convinced to go the cloud computing route, how can you prepare for successful implementation? ARITHMOS offers 5 tips to ensure your cloud-based EDC implementation is a success.

  1. Know the questions to ask your cloud services vendor

Cloud computing may sound simple. Establish an Internet connection and share data across networks. However, if you are considering a cloud approach to EDC, it is critical to know whether your vendor has previous experience and what additional support and security services they provide. Here are some questions to ask your vendor:

  • What is your previous experience in implementing cloud-based EDC?
  • What is your procedure towards network connectivity?
  • Do you implement a risk-based approach to implementation?
  • What are your data security procedures?
  • Does your IT team include a business analysis expert and a compliance expert?
  1. Perform a Business Analysis with your IT Vendor

It is important to know what your business objectives are with a cloud-based EDC solution: faster clinical trials? More efficient data management? Better data quality? Reducing costs?

Discuss these objectives with your IT Vendor and perform a business analysis which will help you define your user requirements. This will allow the vendor to implement a solution customizable to your trial needs.

  1. Search for Pay-As-You-Go or Pay-Per-Use Options

If budget constraints are a primary concern for your company (as it is for most companies conducting trials), look for cloud-based EDC solutions that have pay-as-you-go options for features used or even pay-per-study options. This is achievable in the cloud since there is no software or hardware to install. Therefore, Sponsors can define Service Level Agreements that meet their needs and budgets and increase or decrease functionality as needed.

Again, consulting your IT vendor prior to implementation to define user requirements will help you create a cloud-based solution that caters to your specific, or in some cases minimal, needs to satisfy your budget.

  1. Disaster Recovery Plan, Business Continuity & Cloud Compliance

A Disaster Recovery Plan is absolutely crucial to a cloud-based EDC approach. In a cloud-based world that is dependent on virtual databases, having a backup plan is vital. Discuss a disaster recovery plan with your IT vendor and know exactly what their plan is for power failure, network failure, server damage and backup data centers.

Be sure to implement the following procedures with your IT vendor:

– How will computer system validation be handled?
– How will Installation Qualification be handled?
– How will change control be handled?
– How will encryption be handled?
– How will regulatory inspections be handled?

More importantly, does your provider have a business continuity plan in place to ensure that the organization continues to operate despite any major incidents or disasters.

  1. Implement a Configurable Solution

Cloud-based solutions, in addition to being software/hardware free, also come with a great deal of flexibility. The following points can be considered in a configurable solution in order to save time and costs:
– Ability to reuse the application with slight modification
– Reuse of documentation
– Training effort kept to minimum due to high usability
– Sponsor and site personnel use the same application for different studies
– Ease of managing study personnel credentials

Check out ARITHMOS’ website for more information on our cloud implementation services and computer system validation support. 

 

 

 

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.