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.

 

 

5 Ways Academic Research Organizations Can Cut Clinical Trial Costs

HealthcareAcademic Research Organizations (AROs) face one specific challenge in performing clinical research: strict budget requirements.  AROs usually secure funding from the institution itself, private foundations or even government funding, however with economic downturns and budget costs, AROs are finding it increasingly difficult to secure the appropriate funding for research. Many have partnered with large pharmaceutical companies to bring new drugs to market, but in this case, the university usually takes on a CRO role performing data collection and analysis activities to help the pharma companies cut costs. 

To maintain the integrity of original academic research, ARITHMOS has identified 5 potential ways to cut clinical costs implementing basic technology solutions.

  1. Go Paperless. By now, even AROs can recognize the benefits of EDC vs paper. Besides higher data quality, better patient compliance and real time results, using electronic data collection can significantly reduce costs. Those evaluating the clinical data will have access to data in real time and can make decisions that will reduce trial timelines. The financial benefit of EDC systems is that they produce an overall better Return on Investment in terms of quality and efficiency.
  2. Enlist an expert to define requirements. You’ve made the decision to go paperless, now consult a technology/EDC expert to define user requirements for your organization. Technology business analyst with expertise in life sciences suggest time-saving and cost-cutting measures and make sure your system is compliant with Best Practices and regulatory requirements.
  3. Select an EDC Vendor Wisely: While you’re primary concern may be budget, consider the intuitiveness and operational effectiveness of EDC systems as well as possible integration with ePRO devices. These are all requirements to define in the evaluation phase which can save costs in the long run. Lastly, be sure your EDC vendor provides technical support to prevent cost consuming errors.
  4. Join the Cloud. Consider EDC and pharmacovigilance solutions offered in cloud computing mode – or Software as a Service (SaaS). Cloud solutions can offer scalability, flexibility, self-service and pay-as-you-go options. This allows clinical researchers to pay for the functionalities needed and not pay for those not applicable to the study.
  5. Consider eLearning. Any time a new technology is implemented, training is needed for all users. Rather than factoring in travel and logistical expenses for training purposes, ask your technology provider for an eLearning solution that can be completed in-house and at the user’s pace. This will not only reduce the training budget, but will increase compliance.

ARITHMOS SOLUTION

ARITHMOS caters to the requirements of AROs by defining user requirements that meet strict budgets. As your technology provider, an expert business analyst will define user requirements and provide complete technical support.

ARITHMOS has an EDC solution specifically tailored to the needs of AROs. Symphony EDC is a simple, easy-to-use, intuitive EDC system that has the main functionality of EDC as is relatively inexpensive. This EDC platform is available as Software as a Service and is therefore customizable and with payment options that reflect the functionalities used. Training can be done by academic leaders directly to the end users.

For more information, visit http://www.arithmostech.com or http://www.symphony-edc.com.

6 Factors for a Successful ERP Implementation

In this week’s blog post, ARITHMOS‘ Head of Software Development, Gaetano Giusto, talks about successful ERP implementation. An Enterprise Resource Planning tool can be a key resource for any service-provider industry that manages many projects and struggles with communication between various departments.

By Gaetano Giusto, Head of Software Development

Business chartsIf you are reading this, maybe you are considering implementing or upgrading an ERP in your company, and you want to avoid the common mistakes and pitfalls encountered by many other companies. Searching on the Web, you can find dozens of implementation examples, suggestions, sources and even blogs, but a lot of these sources can just create more confusion. In this blog, I don’t want to talk about numbers or statistics but focus my attention on the most relevant elements you need to implement an ERP system successfully. This is my brief list of the most important factors to take into consideration:

1) Clearly define your needs: Never leave out or hide problems, difficulties, bottlenecks. Think clearly about what you do and do not want from your new system (e.g. more productivity, new sales, increased service levels, less expenses). You can draft several lists to identify your needs, but one final list should be used for your roadmap.

2) Define your measures: The first and most important measure is time. To guarantee a successful implementation, you need to understand when each step of the process should be completed. The second measure is a short set of indicators that will be used to monitor the steps of your roadmap. They can be used not only to respect project timelines, but to also analyze the gap between your expectations and reality. All of your measures and results, including reports, have to be comprehensible and calculated based on all the people involved in the project. The last important measure is the monetary return on investment for your company.

3) Think about people: Consider how many people from your company you need to involve. In addition to planning the number of hours needed for analysis, you also need to consider training hours for learning the new ERP and the productivity hours lost with employees involved in the implementation process. This last point is very important because if you don’t factor in this consideration, your current customers may be unhappy.

4) Invest your money wisely: Implementing an ERP system could be more or less expensive than you originally planned. Calculate your intended budget with room for unexpected expenses in order to allow for a successful implementation of all the elements on your list. All elements on your list should have an assigned budget to evaluate the return on investment of each step and understand if it is economically convenient.

5) Involve Experts: It can be exciting and overwhelming to implement a new system. Before trying something new, I suggest to involve experts in the type of project you intend to do. Involving experts in project management and ERP systems can save  time and money because they will usually assume the responsibilities of the project while you can focus on your customers and employees. They can also suggest time-saving and cost-cutting measures.

6) Be positive and Embrace the Change: Change can be difficult and risky, but great results can be wonderful!

Gaetano is responsible for furthering the development of ArithmosCentrum, ARITHMOS’ proprietary ERP software the manages the information flow between sales, project management, finance and resourcing for any project-oriented service provider. He brings over 15 years of experience in the IT sector and has expertise in software project analysis and consultancy for the implementation and development of business management software.

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ArithmosCentrum is a unique ERP system in that it improves project governance by incorporating project management and back office tasks and linking the project plan to the budget proposal and resource schedule and is customizable for specific industry or company needs.

Risks of Using Discontinued Software: Security and Privacy

ITsystemsecurityIn an increasingly technology-dependent world, software systems are constantly in development and older versions are often left discontinued. End-users should be aware of the risks of using discontinued software and take the necessary steps to understand security and privacy risks to avoid exposure to cyber crime and other privacy vulnerabilities.

In this week’s post, ARITHMOS discusses how service providers should always keep 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.

Cyber security attacks are often caused by unpatched software systems, and this could be the sign of a discontinued software system at risk. Normally during the life cycle of a product, manufacturers produce patches to ensure security. Product maintenance usually ends when the life cycle of the product ends and the manufacturer discontinues all support. This can cause huge risks to system end users and service providers.

End Users can’t check the integrity and validity of a software system because the manufacturer will not keep security up to date after discontinuation. This means that end users may be using infected software systems. More importantly and even riskier, end users could be in danger of non-compliance with industry standards.

Loss of product support by the discontinued software manufacturer could potentially lead to:

  • Discontinued systems will not benefit from security updates or notices
  • New vulnerabilities will no longer be collected, reported and analyzed
  • High risk of service unavailability
  • High risk of cyber attack on data integrity, confidentiality
  • Potential violation of data security laws

In the case of discontinued software, it is the responsibility of the service provider to keep systems up to date with the latest security patches and to migrate to new versions/solutions/platforms. The End User should be aware and understand any security risks involved with discontinued software.

ARITHMOS Case Study – Discontinuation of Oracle Clinical Version 4.5.3 and Microsoft Windows 2000

keyboard-with-security-buttonARITHMOS provided Oracle Clinical RDC Version 4.5.3 for remote data collection for clinical studies. The application and  the database was installed on Microsoft Windows 2000 Server. Oracle ended support for this Oracle Clinical version in August 2013 and Microsoft ended support for Windows 2000 server in 2010. Therefore, as the service provider, ARITHMOS noted the risks to the end user of continuing to use these systems.

As the service provider, ARITHMOS also had to be sure to comply with international regulations and local laws such as the European Commission regulations on data privacy and confidentiality which requires service providers to follow national provisions on data privacy. For example, in Italy there is a law which outlines minimum security measures for personal data protection. In addition, Italian law states that systems/applications must be updated at least every 6 months to prevent intrusion attacks that harm security to personal data.

In the case of Oracle and Microsoft, ARITHMOS upgraded Oracle Clinical to version 5.0 which has manufacturer support through 2018. Consequently, ARITHMOS also installed Oracle Clinical 5.0 on Windows 2008 server which is maintained by the manufacturer through 2020. Therefore, ARITHMOS is guaranteeing security and confidentiality to its clinical trial customers through 2018 when it will evaluate and upgrade its systems.

Implementation of a new Life Science Application: Reduce the project risks by optimizing requirements in the definition phase

projectrisksIn this week’s blog post, ARITHMOS‘ Life Sciences Application Manager, Silvia Gabanti, discusses life science application solutions for reducing the risks of project failure.

Why do IT projects fail?

Projects fail for all kinds of reasons – from insanely low budgets to unwisely tight schedules.

But the main reasons for project failure are (according to CHAOS report – Standish Group):

  • lack of input from the user
  • incomplete requirements
  • unstable requirements

The requirements are often not clearly stated due to insufficient customer/user knowledge of the acquired system (such as changes in legislation, regulations, etc). All too often, stakeholders discover that they have very different pictures of the project scope and of what the new system is supposed to do. Therefore, when implementing a new Life Science solution, particular attention should be paid to the requirement management process in order to avoid increases in the risk creep (unexpected changes), project delays and spiraling costs.

How to manage the risks related to Requirement Definition

A good Project Manager that adopts a risk-based approach to identifying obstacles and establishing measures that will mitigate challenges, should 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. Particularly in the Life Sciences sector, there is a communication gap between the technical team and the key users which can considerably increase project risks.

The Business Analyst’s Role

project assessmentTherefore, the most important responsibilities of the Business Analyst are to act as a “communicator” between the stakeholders and the team, translating the initial high level vision into something realistic and comprehensible. The clear definition of business requirements allows for the reduction of time/costs during the implementation phase, making the configuration phase more efficient and targeted. It also reduces new or modified proposals to the user requirements.

The key users work together with the business analysts to define the system configuration and workflow. In this manner, they can also better analyze the impact of proposed changes during later project phases.

ARITHMOS Approach: The Business Requirement Phase

businessanalystARITHMOS Business Analysts support the key users in the definition of Business Requirements. During this phase, the key users are trained in the functionality and standard workflow of the new system. In most cases, their knowledge is limited to sales and pre-sales presentations, making a Business Analyst essential in this initial phase.

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. They can then define, together with the Business Analyst and technical experts, how the system should be configured. Knowing the system in the initial phase can reduce timelines and risks related to the operational testing phase. Users who are trained and informed on the system adopt a proactive approach throughout system implementation and qualification process.

For more information on ARITHMOS’ life science application process or business analyst services, please contact us at info@arithmostech.com.

ARITHMOS Announces eCRF Symposium for Cost-Effective Studies

doctechPharmaceutical and biotech companies are constantly facing challenges in the drug development process including tighter budgets and the need for higher data quality and accessible, real-time results. Academic research – including studies conducted by academic institutions such as universities, non-profit organizations or research hospitals – often face an uphill battle when it comes to clinical trial funding, trial design and meeting deadlines. The result is that the percentage of trials being conducted in an academic setting is actually decreasing. 

ARITHMOS is hosting a seminar on cost-effective eCRF/EDC solutions in Milan, Italy on Thursday, 10th of April. The seminar will demonstrate how even low budget studies can implement eCRF and EDC solutions to run more efficient trials and facilitate data collection and analysis.

This seminar was created based on the idea that cloud technologies and Software as a Service (SaaS) technologies are becoming an ideal solution for clinical trial professionals. A SaaS electronic data capture (EDC) solution can enhance the overall drug development process in terms of greater efficiency, effective decision-making and, most importantly, cutting costs. Life science applications offered in SaaS mode allow users to pay for functionalities needed, the ability to reuse documentation and the ability to reuse the application with slight modifications for different projects.

During the seminar, ARITHMOS will present Symphony, an EDC platform that is simple, inexpensive and has the basic features of an EDC to meet the requirements of Investigators. Symphony is offered as Software as a Service (Saas), meaning the organization can work independently to set-up the study and build the database.

The speaker lineup is still being finalized, however the seminar will feature an expert panel of clinical trial professionals in the academic and pharma sectors who will discuss increasing efficiency, producing higher quality data with real-time results and improving timelines while staying within budget.

   The eCRF Symposium is sponsored by ARITHMOS and the University of Bicocca-Milan. All participants are invited to a light cocktail reception after the presentations; the seminar is free of charge but spaces are limited. For more information or to register:

eCRF Symposium and Symphony EDC (English Version)

Simposio sulla Scheda Elettronica: Symphony EDC (Versione Italiana)