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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Why Consider a BPS Approach for Life Science Technologies?

Business-Efficiency

BPS – or Business Process Services – is an outsourcing strategy in which companies engage in licensing contracts with a third party vendor for back-office functions such as finance or front-office activities such as customer-related services. ARITHMOS became an Oracle BPS partner in 2011 and explains why the BPS approach in life sciences can be beneficial for companies.

A BPS strategy can take a lot of pressure of a company who wants to concentrate on its core operations activities and not deal with the task of maintaining an IT infrastructure. With more companies, especially in life sciences, using complicated database and reporting systems and cloud-based technologies, they must consider computer system compliance and various regulations. All of these factors can distract companies from their day-to-day operations.

What are the various advantages to a BPS strategy?

1.       Access to Experts in IT Infrastructure: Relying on a third party supplier with expertise in implementing, maintaining and validating systems takes the burden off the company. Expert IT analysts will perform an initial analysis to define user requirements which can reduce time and costs in the implementation phase and increase efficiency in the configuration phase.

Leaving technology activities to the experts allows the company to allocate more time to their business tasks.

2.       Focus on your Business Growth Strategy, Not IT Investment: IT investment for a company involves a significant financial investment, the hiring of more resources, more time allocated to maintaining the system including keeping with regulatory requirements and many, many training hours. In a BPS strategy, the IT experts and engineers worry about streamlining business processes and maintaining IT systems, while the company can focus on business strategy.

 3.       Cost Savings: If finances are a priority, BPS could be an ideal solution. Rather than investing in new technology and in new manpower, companies rely on the third party vendor, who is already streamlining processes and engaging in best practices for other companies. Oracle estimates that with a BPS strategy, cost savings could be between 15-35%.

Benefits of BPS include lower TCO (total cost of ownership) as well as operational costs since BPS looks to streamline administrative activities like payroll and human resource management while linking applications to any IT platform.

ARITHMOS BPS in Life Sciences

img%20per%20sito173116The joint value between ARITHMOS and Oracle exists in ARITHMOS having the capability to use and understand the Oracle applications and offer an optimum value package to clients. In turn, Oracle is providing ARITHMOS with a trustworthy brand and application to enhance the ARITHMOS business strategy through new product offerings.

By partnering with Oracle BPS, ARITHMOS offers its clients:

– Increased business efficiency and productivity with a reputable technology infrastructure
– Reliability through an experienced IT team to consult and manage business needs
– Capability to measure and quantify business efficiency inputs

Visit our website or email us at info@arithmostech.com if you are interested in learning more about the BPS approach from one of our IT and business analyst experts.

Successful Preparation for Regulatory Inspections of Computerized Systems – Part I

Why is inspection readiness so important in handling a successful regulatory inspection of a computerized system? Stefano Piccoli, Director of IT QA & Compliance Consulting Services for ARITHMOS, discusses appropriate preparation techniques in this blog series. 

auditRegulatory agencies often come to inspect your facility for reasons other than your CSV program.  However, because so many of our business processes are governed by electronic systems, the topic of Computer System Validation inevitably comes up during the course of an inspection. As a result of an increase in federal investigators, they are able to inspect more facilities and dig deeper into areas such as Computer System Validation.

Furthermore, in the last decades, regulatory agency investigators have been trained by outside consultants and internally on regulatory issues regarding computer systems.

They have also been well trained on details of operations of typical key computer systems (e.g. MRP, LIMS, CDS, critical Process Control Systems, eCRF, Pharmacovigilance applications)

The result of this training is that more investigators are comfortable asking questions on this subject and they understand your systems better.

For a pharmaceutical regulatory inspection this is a crucial moment to maintain the authorization to produce in a certain market / country and to launch new products (in particular, the inspections by the FDA PAI). In this context, the preparation and readiness for inspection, including computer systems, is essential for the success of an inspection.

 What does computer inspection readiness stand for?

Computer system inspection readiness can be defined as the ability and preparedness of regulated areas to successfully host and withstand focused regulatory inspections of validated computer systems.

Why is inspection readiness important?

TILT_logo_AD_400x305Inspection readiness is a critical element in helping to prevent regulatory citations and achieving approvals of a new drug. It is a mistake to believe that just doing business correctly and meeting regulatory expectations will avoid difficulty in managing regulators. Mistakes made during an inspection can quickly create perception that you are out of control and possibly not in line with regulatory standards.

The intent of hosting the audit is not to “hide” any information from the inspectors. The intent is to ensure the correct information is supplied by the most appropriate person, in a timely manner.

There are several factors to consider when preparing for an inspection:

  • People
  • Behaviour
  • Documentation to review and prepare in advance of an audit
  • Logistical organisation

In Part I of this blog on CSV inspection readiness, I would like to start talking about the people involved. In subsequent blogs I’ll concentrate on the other factors.

The selection of the audit team for the computer systems under inspection is fundamental. It is important to select the appropriate people to be part of the inspection team in advance and keep people prepared and trained on how to handle the inspection and what behavior to have in front of the inspectors.

The following criteria should be used for the selection:

  • Competent
  • Confident
  • Credible
  • Knowledgeable
  • Honest

The following key people/roles should be selected and kept ready to present different computer systems

  • Computer validation managers. Usually they are the key speaker during inspection, as they are the more experienced and trained people on regulations about computer systems.
  • Process owners as they are using the systems according to SOPs and they are experts on the processes supported by the system. They are usually involved to explain how the system is used according to the SOPs and present user requirements and user acceptance testing.
  • System owners identified for all computer systems used at the facility/department being inspected. They are responsible to explain how the system is supported and maintained in accordance with applicable SOPs.
  • IT infrastructure representatives available to explain infrastructure processes supporting the computer system(s).

For more information on Computer System Validation processes or steps for regulatory inspection, contact us at info@arithmostech.com. ARITHMOS has supported numerous companies in the preparation of regulatory inspections in the clinical trial environment and can support with preparation and documentation.

 

 

Countdown to DIA Boston: 3 Reasons to Visit Arithmos at Booth 607

The countdown is on to the DIA 49th Annual Meeting in Boston, Massachusetts taking place June 23-26. With just 10 days to go, Arithmos is excited to be a first time exhibitor at Booth 607 as it introduces its clinical trial technology services to the North American market. Read more to see what you can expect from Arithmos at the DIA Boston conference this year.

1. Demos of ArithmosCentrum

AC DIA2013ArithmosCentrum is an ERP system specifically designed to meet the challenges of CROs. The ERP system was developed by Arithmos with the goal of providing a project management system that incorporates other office tasks and linking the project plan to proposal, budget and scheduling. ArithmosCentrum helps improve project governance and reduce administration time in all departments. Using this system, CROs can produce budget proposals faster, efficiently manage project plans and stay on budget for all projects. They can also manage increased workload by forecasting the resources needed in the future.

Throughout the DIA conference, Arithmos will be providing demos of ArithmosCentrum at Booth 607. If you prefer a private demo, please email us at info@arithmoscentrum.com prior to the show.

 

2. Networking Event at the New England Aquarium – 25 June at 6 p.m.

To celebrate our expansion to the North American market, Arithmos is co-sponsoring a networking event at the New England Aquarium the evening of June 25th in the West Wing Gallery. The event will include a cocktail reception and an interactive shark tank! We invite you to join us at this great event, however space is limited, therefore contact us to reserve a ticket which can be picked up at Booth 607.

Aquarium Invite

3. Booth Giveaways

Be sure to visit our booth for some of our great giveaway items like mobile and tablet screen cleaners and enter your business card to win an iPad Mini.

ARITHMOS provides IT products and services to different industries but with a special focus on making the conduct of clinical trials faster and more efficient for Pharmaceutical, Biotech and Medical Device companies, and also CROs. The company provides products for ePRO, EDC, Pharmacovigilance, eLearning, Data Visualization and Project Governance. Services include data integration, computer system validation, hosting and HelpDesk.