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.

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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. 

 

 

 

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

Cloud-Based EDC Part 1: 10 Reasons to Consider a Cloud-Based EDC System

cloud-based EDCThe pharmaceutical industry has already been using cloud computing primarily for research purposes. 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.

If the market continues to adopt EDC/ePRO technologies, paper studies and subject diaries may no longer exist in 10 years or less.

Electronic Data Capture (EDC) has been one of the technologies frequently adapted to cloud-computing for clinical research. In this two-part blog, ARITHMOS will first list 10 reasons to consider a cloud-based approach to electronic data collection, analysis and reporting. In Part two, we will discuss how to implement a cloud-based EDC system.

10 Reasons to Implement Cloud-Based EDC

1. No more hardware/software installation

According to recent industry reports on cloud computing, 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 such as 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.

2. Pay on a Per Study or Per Functionality Basis

With no hardware/software installation or IT infrastructure investment and no need for an expert consultancy team, the Cloud allows users to pay per study, or in some cases, by functionality used. This can result in huge cost savings for companies on a tight budget.

3. Risk-Based, Remote Monitoring

It is encouraged by regulatory authorities and Cloud based EDC allows for real time data collection and immediate analysis and reporting from various devices, anywhere there is a connection.

4. Mitigate Risk

The Cloud makes it easy to collect and transfer data into one database for quick and accurate analysis. Using HTTPS connection and various security measures, companies can ensure secure and private data transfers. Avoiding hardware/software installation also means fewer technical problems to deal with as a company, and therefore the company can focus on trial conduct and not technology issues.

5. Faster Trials

Cloud-based data delivery and management is a surefire formula for speedier clinical trials and makes proof of concept testing faster and easier.

6. More Efficient Data Management and Better Data Quality

Resolve discrepancies faster and reduce time and costs with immediate feedback from patients; Data can be transferred in real time during the study and query management is accelerated.

Ensure automated edit and discrepancy checks, faster data cleaning, audit trails and compliance with GCP and regulatory guidelines.

7. Better Global Study Program Organization

Organize multi-language, global study data into a single database; this is especially beneficial to statisticians who need up-to-date study metrics in other parts of the world.

8. Convenience of Software Reusability

With the cloud, it is possible to use the same software application for various studies which is very convenient for study sponsors. Sponsors can save time and effort on training since all data will be in one database and there is only one system to learn.

Cloud-based EDC is also more convenient for an RBM approach making it easier to analyze data across different studies.

9. Reduce training time and costs

Training efforts are kept to a minimum because of high usability and the ability to implement cloud-based eLearning solutions for EDC systems. This reduces training logistical costs for companies on strict budget requirements.

cloud10. Considerable Cost Savings

All of these above-mentioned factors lead up to the main selection driver for most companies: COST. The elimination of hardware/software and the associated consultancy, quicker and more efficient trials and better management all result in considerable cost savings.

 

Related Links

ARITHMOS Cloud Implementation Services
Symphony EDC 

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.

 

 

 

Pharmacovigilance Practices Part I: Argus Data Migration

In this two-part blog, ARITHMOS takes an extract from its article series on migrating safety data and cases from legacy pharmacovigilance systems to Oracle Argus. ARITHMOS describes the process involved in data migration and validation principles and considerations during the production phase to ensure efficient and cost-effective pharmacovigilance practices. In Part II of this blog, coming next week, ARITHMOS will discuss what happens after migration and how joining its consortium initiative can result in considerable cost savings.

Oracle AERS premium support will end in 2015, and various other pharmacovigilance systems offer limited support. Therefore, ARITHMOS recommends a data migration project to Oracle Argus Safety, which is an up-to-date pharmacovigilance sytsem that meets all the requirements of computerized systems in the GVP environment.

Hand press on First Aid Symbol , medical background

How would an implementation project work?

As an Oracle Business Processing Services Provider (BPS), ARITHMOS provides the Oracle Argus Safety Version 7 license with payment based on cases entered in a defined time period with no annual maintenance fee. The process for migration includes:

  • Business Requirements Analysis
  • Configuration Analysis
  • GVP Validation Assessment
  • Detailed User Requirements definition (including configuration workshop)
  • Data Migration strategy
  • Configuration set-up and pilot testing system design specifications
  • Design, Build and Test Data Migration solution
  • System Installation
  • Validation Testing (IQ, OQ) and Business QC of migrated data
  • End Users training and User documentation
  • Validation Testing (PQP) and Production Data Load
  • Validation Report

This process can take an estimated 6-8 months to complete, therefore if a legacy system is still in place in your company, it is best to begin the migration process.

Due to increased regulations on safety data and the need to improve data quality, ARITHMOS can guarantee real-time reporting solutions for Oracle Argus Safety Version 7 including integration with Oracle Business Intelligence with reports directly on smartphones and tablets.

Validation Principles and Best Practices

The data migration progress guarantees:

  • Risk Based Approach
  • Proactive validation
  • Use of international standards (GAMP 5) and Internal QMS
  • Use of templates and validation scripts
  • Monitoring and control over the project
  • Multidisciplinary project team covering the key aspects of validation (business analysts, IT experts, CSV & QA specialist)

A dedicated Account Manager will provide support during the production phase including operational technical support, user access management, periodic review and support in preparation and conduction of regulatory inspections. ARITHMOS can also support in the decommissioning of the legacy pharmacovigilance system.

argus safetyIn Part II, ARITHMOS will explore what happens after data migration and how companies can properly maintain their pharmacovigilance system. If your company is considering a migration project from a legacy system to Oracle Argus Safety Version 7, schedule an assessment meeting with ARITHMOS to learn your business and user requirements.

FDA 483s & Warning Letters and How to Avoid Them

computer_warningThis week ARITHMOS has been focusing on Computer System Validation and the importance of implementing a proactive approach to system validation and maintenance. In this week’s blog post, we look at FDA warning letters, what they mean and how to avoid them by following the computer system validation life cycle.

Warning Letters represent two of the three steps that are important to a GxP assessment of deviations.

  • The first step are deviations reported on the well-known FDA-483 Form by an FDA inspector at the time of inspection.
  • A Warning Letter is issued if the EIR (Establishment Inspection Report) written by the inspector has been checked by the head office and the deviations have been classified as significant or the statement on the elimination of the faults has been classified as insufficient.

If the answer to the Warning Letter is also insufficient from the FDA’s point of view, they enforce step three:

  • The inspected site cannot manufacture products for the US/American market until further notice

What are the most notable deviations that result in FDA-483 forms and Warning Letters?

  • No individual passwords which can cause repudiation problems
  • Insufficient system security
  • No electronic audit trail
  • (Electronic) raw data not saved or lost
  • No correlation between e-records and paper print-outs
  • No back-up of data
  • No prevention of data deterioration during archiving
  • Lack of or inadequate computer system validation

Implementing a CSV Plan to Avoid FDA-483s and Warning Letters

Sponsors can avoid the deviations above by performing a risk assessment on their computerized systems and then maintaining system performance through periodic reviews and change control. The Computer System Validation life cycle follows a process that tests systems throughout the Software Development Life Cycle (SDLC).

For example, let’s look at the requirements for Electronic Records and Electronic Signatures (ERES). ERES requirements are related to the validation of the system and maintaining the system in a validated state. Inspectors will look at a combination of technical controls provided by the system and procedural controls provided by users or administrators of the system.

Therefore, how can Sponsors approach CSV?

  • Planning and Requirements: Validation should cover both technical solutions and the implementation of any procedural controls for electronic records and signatures. Define compliance requirements, create a validation plan and define user requirements.
  • From Designing to Deployment: Design and build requirements, perform development testing  and deploy the system to satisfy all user requirements
  • “In Use”: Provide training, define a security procedure in a System Access Plan, retain records according to their retention period and record copies which need to be provided during inspections.
  • Cross Phase: Ensure that anyone who develops and maintains systems has the education, training and experience to perform the tasks at hand. An appropriate Document Management Plan should also be defined including a maintenance plan according to change control. Also ensure that a Change Management Process is in place to maintain the validation status.
  • Decommissioning: Systems should be decommissioned in accordance with a Decommissioning Plan. Validation documentation must be archived and data maintained in according to the retention period. Even if the system is decommissioned, it must be guaranteed that copies of records are available during inspection.

The FDA requires that organizations comply with all applicable regulatory validation requirements including validation of design, computer software for its intended use and software changes before approval and issuance. Contact ARITHMOS to discuss or strategic and maintenance approach towards CSV and our expert advice on how to avoid FDA (and other regulatory bodies) Warning Letters.