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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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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The Future of Clinical Trial Technology: Trends to Watch

Earlier this month, in a speech to Oxford University students, the former CEO of Microsoft, Steve Ballmer, said that the future is “cloud and devices”. In this case, the Sponsors of clinical trials should be looking to adopt technology solutions today as an investment in future efficiency and cost cutting measures. In this week’s blog post, ARITHMOS looks at technology trends that are shaping the clinical trial environment and offers solutions that can be implemented to start improving trial performance.

 

1. JOIN THE CLOUD.

cloudtrendsIf your company has not considered cloud-based technologies for clinical trial operations, it’s time to get on board. EDC systems, pharmacovigilance systems and reporting tools are offered in both Software as a Service (SaaS) and Platform as a Service (PaaS) mode meaning there is no installation or purchase of hardware or software which significantly reduces operational costs.

Cloud computing can increase employee productivity and collaboration since they can access the application from anywhere and communicate in real time via the application rather than meetings and emails.

Cloud computing can also be more secure than software and hardware installation. Service providers can ensure high levels of security, run security patches and perform validation and maintenance services.

Solutions for Clinical Trials: ARITHMOS can provide several cloud-based solutions for Sponsors of clinical trials. We have a cloud-based EDC system, Symphony, which simplifies data collection and management. eCRFs can be designed independently without particular need for technical skills. Additionally, ARITHMOS provides pharmacovigilance database and reporting solutions as Software as a Service (SaaS) meaning your safety data is available in real-time and in compliance with regulatory standards. ARITHMOS also offers clinical data reporting solutions in cloud mode so Sponsors can analyze study data and reports from multiple sources.

 

2. PICK YOUR DEVICE.

Approximately one in every five people worldwide has a smartphone, and 6% of the world’s population is using tablets which are demonstrating a faster adoption rate than smartphones. So, why not use smartphones and tablets in clinical trial operations?

The best example of devices in the clinical trial environment is smartphones and tablets as ePRO devices. ePRO takes the burden off the subject and allows clinical trial leaders to have more control over the situation. Devices can be programmed to send reminders to subjects so they fill out diaries with real time data and submit data in real time. Moreover, studies have demonstrated that subjects have a greater sense of privacy with ePRO devices. Subjects might be hesitant to respond honestly on a paper form knowing that various people will read their answers.

Lastly, clinical trial leaders no longer have to manage paper questionnaires with the risk of losing clinical data or having to interpret illegible responses.

Solutions for Clinical Trials: ARITHMOS has experience implementing ePRO systems using iPhone, Blackberry and Android as well as tablets such as the iPad and Samsung Galaxy Tab. These devices have proven to be intuitive and increase patient compliance as well as provide applications with medical and health related information. It is also possible to implement therapeutic area specific devices. ARITHMOS has used a spirometric device for respiratory trials and glucometers for diabetes trials.

 

3. CONTEXTUALIZE YOUR DATA

In 2014, there is no reason Sponsors shouldn’t have real-time access to clinical data in a clear way. Clinical data visualization tools are available to create efficient and customized reports. These tools manage vast amounts of data and present them in visual tables and graphs to simplify analysis and make important decisions about study progress.

Solutions for Clinical Trials: ARITHMOS works with the best Business Intelligence providers to offer a state of the art visualization tool. We can then integrate data visualization tools with your handheld devices for real-time access to clinical data anytime, anywhere.

 

4. BE SOCIAL.

pharmasocialmediaSocial media is a technological area that is still growing in clinical trials. How can Sponsors and Investigators connect directly with patients through various social media outlets such as Facebook, Twitter or even LinkedIn? Will there be a future social media hub just for clinical trials?

Social Media may also play a key role if the European Union moves forward with its data transparency initiative. How can companies present data in a clear and transparent way using social media tools?

Can social media eventually be used for signal detection and other pharmacovigilance needs?

Sponsors should begin analyzing the potential of social media and the impact it may have on clinical trial operations and marketed products.