Why Project ERP is a Worthwhile Investment for CROs: Ensuring ROI

ACimageTo stay competitive, CROs need to focus on efficient project management and operational excellence. A project-based Enterprise Resource Planning (ERP) provides better organization, document management, scheduling and resource planning and communication.

However, one of the biggest challenges CROs face is when to risk on technology investments that can streamline processes while juggling limited resources and budgets that make an ERP investment seem too risky.

When it comes to selecting and implementing an ERP system, CROs are generally hesitant over particular these challenges:

Selecting an ERP system

CROs need to analyze their needs before comparing ERP systems. Basic systems will manage back office tasks and project management, but will they fully connect all your core business units including human resources, scheduling and finance? Meanwhile, larger systems may include unnecessary functions and complex processes that require additional investments in resources and training. CROs should start their ERP selection with companies that can offer a User Requirement Analysis. This crucial first step allows SMBs to define requirements that meet defined budget expectations.

Implementing an ERP System

CROs may argue that they lack the resources and technological competence to implement their ERP system which translates into needing additional outside consultancy for installation and extensive training. CROs should, first of all, keep in mind that implementation is the biggest milestone in the overall investment. ERP implementation will improve processes and efficiency in the long term, so CROs shouldn’t focus heavily on the costs of implementation but rather avoid “add-on” costs during implementation.

Lack of Resources

Once again, CROs need to see the long term benefit of the ERP system. Once administration processes are automated and departments are interconnected, employees will be able to spend less time on tedious “housekeeping” tasks and focus on client and business objectives.

Unpredictability

main_image_careersUnpredictability can hit CROs hard in that most will have dedicate most of their resources to managing unpredictability, and it can take a bigger toll on budgets and efficient project management which may affect communication with the client.

Document management and administrative tasks are streamlined and electronically archived so CROs can have a proper project audit trail and Sponsor records. Most importantly, a unified system that connects a project plan with the budget and resource scheduling and includes automatic alerting, CROs can be sure projects are on track and reduce unpredictability and better manage communication with the client should an unforeseen event occur.

ARITHMOSCENTRUM – Guaranteeing Return on Investment for CROs

A unified system allows for the sharing of information and data without needing multiple systems and reports and creates a central hub for document management and quality control. Administration costs are reduced in the intermediate to long term by integrating operations and business which requires less interaction between departments for back office tasks. More importantly, with ArithmosCentrum CROs can be up and running within a few days with no disruption to current projects. The system is entirely configurable to use your own terminology, processes and templates, and historical data can be imported during set up.

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.

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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In Copenhagen, Technology is the Focus of Nordic Life Sciences Events

Next week, ARITHMOS is in Copenhagen to sponsor to life sciences events that focus on evolving trends in the clinical trials sector – pharmacovigilance and Risk-Based Monitoring. Technology takes center stage when looking to implement solutions that can ensure data quality, improve efficiency and cut costs.

Nordic Pharmacovigilance Day
7th of October – Carlsberg Museum & Business Centre in Copenhagen, Denmark

????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????????Pharmacovigilance Day focuses on “designing an efficient pharmacovigilance system” and how the use of electronic systems can help companies achieve the effective safety system required by law, especially under the new GVP guidelines.

ARITHMOS has pointed out before that the system you choose should be compliant with global adverse event reporting standards as well as with standards of main regulatory bodies. For example, the EU has relased good pharmacovigilance practice guidelines (GVP) which focuses on “proactive and proportionate risk management”, higher quality of safety data and “strengthened transparency”.

  • Does the system have technologically advanced reporting tools?
  • Is the system intuitive?
  • Is the system available in the cloud?
  • Does the system have the appropriate coding functions?
  • Who will take care of the hosting, validation and maintenance?

Speaking of pharmacovigilance in the cloud, Pharmacovigilance applications should be accessed through the Internet with minimal IT effort through web browers with no installation required on a PC. Another option is to publish the application in Citrix with only a plugin to install. A cloud computing and SaaS solution is a valuable technological trend for efficient application delivery. The burden on the customer is reduced in terms of hosting and maintenance and the default configuration meets standard business processes. This solution is flexible to changing business and operational needs and guarantees an efficient and cost-effective solution.

 

Nordic ePharma Day
8th of October – Carlsberg Museum & Business Centre in Copenhagen, Denmark

At Nordic ePharma Day, the topic on the table is Risk-Based Monitoring the role of technology in supporting the transition from the “common” to the Risk Based Monitoring.

Centralized Monitoring has been proposed as a new, more efficient and cost‐effective approach to on‐site visits. A CSM approach performs data quality checks on all trial centers at the subject and site level. Statisticians can then analyze the data in real time to identify sites that need further investigation due to unusual data patterns. In a CSM strategy, many discrepancies can be improved by implementing cloud‐based technology solutions. Clinical Data Visualization and analytical business intelligence tools should be considered to query the EDC database and design reports for the main personnel involved in the trial review that assess site activity for quick analysis and decision‐making. 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”.

ARITHMOS is pleased to sponsor both of these Nordic Life Sciences events and promote the role of technology is these life sciences trends. If you are interested in attending these events, please visit the event websites. If you have a need for technology solutions in pharmacovigilance or Risk-Based Monitoring, please contact ARITHMOS for an RFP.

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. 

 

 

 

ARITHMOS Launches Survey on Pharmacovigilance Market & Challenges

In an effort to better understand the complicated, yet growing, pharmacovigilance market, ARITHMOS has launched a survey on present challenges facing pharmacovigilance professionals.

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This market survey aims to meet two key objectives:

– Understand the most pressing issues pharmacovigilance professionals face in terms of safety systems, inspection readiness and reporting
– Understand expectations in terms of financial investment in safety systems and what constitutes a good Return on Investment

The ARITHMOS pharmacovigilance survey is intended for market research purposes only and should take approximately 10-15 minutes to complete.

TAKE THE ARITHMOS PHARMACOVIGILANCE SURVEY

Pharmacovigilance Best Practices Part II: Consortium Initiative

In Part II of ARITHMOS‘ article series on pharmacovigilance best practices, we address the need of project implementation and maintenance by introducing the Consortium initiative which helps companies significantly reduce costs while receiving expert advice from cross-functional teams.

Two hands touch screen of tablet with medical icons. VectorIn order to facilitate the implementation, production and maintenance phases of a pharmacovigilance system migration project, ARITHMOS has introduced a consortium for the provision of Oracle Argus Safety Version 7. The fundamental idea behind the consortium is that customers take advantage of lower costs 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.

The concept of sharing implementation activities guarantees at least a 20% reduction in costs for Consortium subscribers. The benefits to joining are:

  • Access to experienced Project/Account Manager during set-up and production
  • Get a standard configuration built on best standard practices and experience
  • Have the PhV application hosted in a certified Data Center with backup/recovery processes in place
  • Compliance and regulatory expertise and support during inspections
  • Use of International Standards (GAMP5) and Internal QMS
  • Multidisciplinary team covering all validation aspects (Business analysts, IT experts, CSV specialists)

Why is the Consortium an ideal solution for pharmacovigilance departments?

Step 1: Oracle Argus Safety Version 7 is an ideal solution for managing global workflow while providing case reports and instant safety data reports and analysis. It is an up-to-date pharmacovigilance system that meets all the requirements of computerized systems in the GVP environment. As an Oracle Business Processing Services (BPS) provider, ARITHMOS provides the Oracle Argus Safety license with payment based on cases entered in a defined time period with no annual maintenance fee.

Step 2: The Consortium initiative also covers compliance and Computer System Validation aspects of pharmacovigilance through a Quality by Design approach. As a member of the Consortium, a cross-functional team of validation experts are available to make sure the system is maintained properly through periodic review and change control.

Consortium ROI: Consortium membership guarantees cost reduction through the sharing of implementation activities and documentation. However, the real Return on Investment comes from access to validation experts, advice and feedback from other Consortium members and access to “My Oracle”, which is Oracle’s official web portal for the support of its applications – guaranteeing a smooth, compliant and risk free pharmacovigilance process.

The Consortium is a yearly initiative with limited subscriptions available. For more information on a pharmacovigilance system migration project and Consortium membership, contact ARITHMOS at info@arithmostech.com.