Smart Strategies for Pharmacovigilance: Data Migration

CDV1Pharmacovigilance is becoming a more pressing issue in the drug and device cycle, mostly due to increased regulations by the FDA and EMA which are looking to increase patient safety in both clinical development and post-market use. Companies engaging in clinical development need a proper pharmacovigilance system that can manage case processing and vast amounts of data.

ARITHMOS discusses the importance of keeping systems up-to-date and the risks involved in running discontinued systems. Specifically related to pharmacovigilance and end users, ARITHMOS addresses issues associated with using Oracle AERS and Trace, two pharmacovigilance systems that will move from premium support to sustaining support (AERS 4.7 in January 2015, Trace in August 2016) meaning support services are limited and migration is recommended.

During the life cycle of a product, manufacturers produce patches to ensure security, and therefore when the life cycle of a product ends, the manufacturer discontinues full support (or in Oracle’s case, premium support). More importantly and even riskier for end users in the clinical development sector, this could put companies in danger of non-compliance with industry standards and regulations.

In the case of discontinued or outdated software, the service provider can’t keep systems up-to-date and recommend migrating to new versions or platforms.

Smart Strategy: Migrating to Oracle Argus Safety Suite

argus safetyOracle Argus Safety Version 7 is an ideal solution for managing global workflow while providing case reports and instant safety data reports and analysis. Oracle AERS premium support will end in 2015, and therefore ARITHMOS recommends a data migration project to Oracle Argus Safety. Argus Safety is an up-to-date pharmacovigilance system that meets all the requirements of computerized systems in the GVP environment. As an Oracle Gold Partner, ARITHMOS can offer Oracle Argus Safety Version 7 as well as migrate safety data from legacy or discontinued systems.

As an Oracle Business Processing Services Provider (BPS), ARITHMOS provides the Oracle Argus Safety license with payment based on cases entered in a defined time period with no annual maintenance fee. The process for migrating from a discontinued system starts with a Business Requirement and Configuration analysis through to validation testing and reports.

Due to increased regulation on safety data and  the need to improve data quality, ARITHMOS can guarantee real-time and customized reporting solutions for Oracle Argus Safety including integration with Oracle Business Intelligence.

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The Ideal EDC System for Clinical Data Managers

At ARITHMOS‘ eCRF Symposium this month, the Director of Clinical Data Management for an international CRO, gave a presentation on the ideal EDC system and what functions are necessary for successful data management. Monica Pimazzoni has over 20 years of experience in clinical data management for both large pharmaceutical companies and in the CRO environment, and she shares her opinion of the ideal EDC system.

Conducting a clinical study requires the collection of a large amount of data that can be entered, checked, confirmed and finally grouped together in a single database. These steps require significant logistical means in order to comply with the GCP (Good Clinical Practice) and regulations on the protection of people’s safety and well-being. Setting up a central database and an electronic collection via the Internet called eCRF (electronic case report forms) meets these needs by combining technology, simplicity, privacy and data security.

What are the challenges of using paper CRF?

  • Massive amount of paperwork
  • Tedious for Investigators – repetition, data transfer, consistency
  • Tedious for Monitors
  • Tedious transport and archive activities
  • Logistical issues
  • All data must be transcribed
  • Data cannot be evaluated in real-time
  • More time and effort needed for data cleaning
  • Extended timelines from LPLV to DB lock

eCRF significantly reduces the time and costs for certain stages of a clinical study. Direct and indirect costs can be reduced thanks to parallel operations during the use of a centralized database that can be accessed simultaneously by many people using the Internet. eCRF ensures:

  • Privacy and security (password login, encrypted data, secure protocol)
  • Source data collection by the users (no double entry)
  • Effective and immediate communication between participants
  • Optimization of site visits by upstream preparation
  • Significant reduction of data collection errors through input controls
  • Remote monitoring
  • Better data input quality
  • Interim analysis that can be implemented quickly with snapshots of data exports

How to choose an EDC system:

In Europe, it is a legal requirement to conduct clinical trials in accordance with the International Conference on Harmonisation’s guidelines on good clinical practice. This leads to reporting and documentation requirements that are burdensome and complicated. There is almost a complete absence of guidance from regulatory agencies about how to evaluate the many EDC systems available.

The availability of cost-effective, open source or proprietary EDC applications for individual physicians/researchers, departments and institutions has the potential to improve clinical and research activities. Since further development/customization and ownership costs are lower, Sponsors can modify and adapt EDC systems to suit their environment and workflow, thus ensuring the success of EDC implementation. User-friendly and simple interfaces, adherence to industry standard security protocols, customization and low maintenance costs are some of the major benefits.

Cost is an important, if not the most important, factor to be considered while choosing an EDC system. Although the nature of licensing and support required to maintain EDC systems are the main predictors of cost, data capture and workflow at the site of implementation also have a major influence.

Commercial EDC systems can be expensive in comparison to open source or proprietary EDC systems. It is important to evaluate the cost-benefit analysis of each EDC system and find the functions that best fit your company’s needs and budget.

What do Clinical Data Managers Want?

  • An EDC system compliant with regulatory requirements: audit trails, data validation, system integrity
  • A system that enhances communication and sharing with users
  • Flexibility to allow for study specific customizations and dynamic forms
  • Intuitiveness and user-friendly system that is easy to navigate
  • Intuitive to select visits and enter data for end users
  • Easy to retrieve data queries
  • Efficient data cleaning and easy to update
  • Easy for study monitors to perform and mark SDV
  • Easy for Investigators to sign when CRFs are complete

ARITHMOS Solution

ARITHMOS has various EDC solutions available depending on the Sponsor’s needs and budget. Sponsors can meet with one of our business and application analysts to define user requirements. ARITHMOS can also support licensing, implementation and maintenance needs for various EDC systems as well as provide ongoing support in terms of HelpDesk and eLearning.

ARITHMOS also offers a proprietary EDC system, Symphony EDC, which is an affordable system that covers the main functions for data collection and reporting and can be customized based on study needs.

Ensuring Clinical Data Integrity: eCRF Validation

stock-footage-portrait-young-female-hospital-doctor-using-computer-to-input-data-on-clinical-trialsLast week, ARITHMOS hosted a symposium on eCRF, and Stefano Piccoli, Director of IT QA & Compliance, gave a presentation on ensuring clinical data integrity through validated eCRF. Stefano’s presentation looked at GCP requirements for source data, the risks of relying on sources like Excel or Access to manage data and how eCRF can help ensure data integrity.

According to ICH E6 Good Clinical Practice, “all clinical trial information should be recorded, handled and stored in a way that allows its accurate reporting, interpretation and verification”.

This means that data must be:

  • Accountable/Attributable
  • Have an audit trail: proof of authenticity, details of computer system configuration, reports changes, records dates/times
  • Available for the life cyle of the data
  • Have back-up and recovery
  • Accurate and reliable
  • Have physical and logical security

When clinical trial Sponsors are on tight budget restrictions, they may implement data collection methods such as Excel spreadsheets and Access databases with data sent via email. Risks associated with this method include:

  • Lack of compliance
  • Data is not secure: limited permission controls and protection
  • Errors go unnoticed: data entry error can easily go undetected
  • No central location for forms and data
  • Database is often not validated
  • Data is not available in real time

Electronic Record Solution

Electronic records cover appropriate measures for clinical trial data: security, integrity and traceability

An eCRF (electronic case report form) is a secure, efficient and cost-effective solution for collecting clinical data. Web-based solutions provide data security through an HTTPS secure protocol and proper access roles and security settings. In terms of traceability, eCRF solutions have audit trails, time stamps and electronic signatures. More importantly, data are stored in a compliant data center with a back-up and disaster recovery plan.

Data integrity is not only an efficient way to conduct clinical research, it is a regulatory requirement. It can be ensured through choosing a proper technical solution which enables data security and traceability as well as appropriate computer system validation  and maintenance.

ARITHMOS Solution

ARITHMOS has a proprietary, web-based EDC system, Symphony EDC, which has all the main functions of an EDC system and is customizable. The system provides an audit trail and secure, web-based data collection and data transfer. Customized reporting and real time access to data allows Sponsors of clinical trial to perform edit and discrepancy checks and make quick decisions on clinical trial progress.

ARITHMOS Hosts Successful eCRF Symposium in Milan

clinical-trial-deviceLast week, ARITHMOS hosted a symposium on eCRF needs and requirements for various sectors conducting clinical research. The purpose of the symposium was to discuss the importance of eCRF vs. paper trials and how Sponsors conducting trials on restricted budgets can still implement eCRF and EDC solutions. The symposium was hosted at the University of Milan-Bicocca, which is celebrating its tenth year of the Faculty of Statistics. 

The symposium included presentations on eCRF requirements for the CRO environment and in academic research. Professor Giovanni Corrao of the University of Milan-Bicocca discussed requirements for academic clinical research.

One of the main points of the event was: why eCRF?

Conducting a study requires the collection of a large amount of data that can be entered, checked, confirmed and finally grouped together in a single database. These steps require significant logistical means in order to comply with GCP (Good Clinical Practice) and regulations on the protection of people’s safety and well-being.

The setting up of a central database and an electronic collection form via the Internet called eCRF (electronic Case Report Form) meets these needs by combining technology, simplicity, privacy and data security. The use of electronic case report forms to gather data in randomized clinical trials has grown to progressively replace paper-based forms.

Cost is, of course, an important factor to be considered when choosing an EDC system. Although the nature of licensing and support required to maintain an EDC system are the main predictors of cost, the purpose of data capture and workflow at the site of implementation also have a major influence. Commercial EDC systems are expensive in comparison to open source or proprietary EDC systems, the latter being more common in the non-profit, academic sector.

symphonyThe symposium pointed out that smart open source and/or proprietary EDC systems offer enormous opportunities to expedite clinical trials. They can be tailored to the needs of all parties involved and still perform numerous trial functions. These systems can simplify study monitoring and reduce costs for on-site monitoring visits. Additionally, they can improve safety monitoring through real-time surveillance. These systems would empower and enable a wider variety of people to conduct trials since capturing, cleaning and extracting data would not be overly daunting or expensive. While a proprietary system can be beneficial and cut costs, it is also important that the system be cloud-based, as pointed out during the symposium, in order to manage studies anywhere, anytime with no hardware or software installation required.

ARITHMOS’ Stefano Piccoli, who leads IT Quality & Compliance, discussed the importance of data integrity and having a validated eCRF to be compliant with EU regulations and GCP standards.

ARITHMOS finished the symposium with a demo of its propriety, cloud-based EDC system, Symphony, which is an affordable EDC system that has essential features such as database build, integration with ePRO and customizable reporting tools. For more information, visit www.symphony-edc.com and check the ARITHMOS website for upcoming events and symposiums. 

The Role of Technology in the European Union’s Data Transparency Law

l_1171_ema-transparencyLast week, the European Union took a significant step in advancing the European Medicine Agency’s initiative on clinical trial data transparency. The EU approved a draft law that will require Sponsors to publish full clinical trial summaries in an EU database accessible to the public upon marketing authorization. This news comes one month after the EMA published a summary of a Risk Management Plan (RMP) for the first time for a newly authorized medicine. 

The EU draft legislation states that, “in a clinical trial the rights, safety, dignity and well-being of subjects should be protected and data generated should be reliable and robust”. ARITHMOS looks at how technology will play a greater role in the data transparency initiative.

Clinical Data Visualization will perhaps be the most important technological component for Sponsors conducting trials in Europe who need to make more informed decisions and make sense of clinical data which could eventually be shared publicly. Conducting a trial generally leads to data being spread across multiple databases including EDC, CTMS, ePRO, safety databases, etc and if a centralized biometrics approach was not employed, such databases can be spread across multiple vendors and countries.

main_image_careersData Visualization tools facilitate drill-down and click-through to multiple levels of detail, allowing for the analysis of specific subsets and sub-populations. Customizable dashboards allow the clinical team to create ad hoc reports on site performance, data quality, safety and efficacy, drug supply, patient management etc. Using data visualization tools, clinical leaders can see information that is beyond the capability of the CTMS report set.

The return on investment from the implementation of data visualization tools is the amount of time saved by being able to access and analyze data immediately and using data to identify and fix problems.

What solutions are available for clinical data visualization?

ARITHMOS can facilitate the selection of data visualization tools by offering a variety of solutions for managing clinical trial metrics – especially cloud-based solutions that are available right on your smartphone or tablet.

ARITHMOS has partnered with some of the best business intelligence and data visualization providers to allow Sponsors to benchmark studies and track progress as well as understand Key Performance Indicators. ARITHMOS can also integrate Business Intelligence tools with Data Visualization tools on your handheld device.

With regards to pharmacovigilance and safety data, real time safety data is crucial. ARITHMOS offers cloud-based data visualization solutions for clinical safety reporting from the best pharmacovigilance systems and databases.

Why should clinical trial Sponsors conducting trials in Europe be considering technology solutions?

The EU draft law on data transparency is set to go into effect in 2016 and Sponsors can face heavy fines if they do not comply. Implementing technology solutions such as centralized storage, cloud-based clinical data visualization tools and real-time clinical safety reporting tools will allow Sponsors to prepare their data not only in a transparent way, but also in a traceable way for regulatory authorities. Being able to make real-time decisions based on readily available data will save Sponsors time and inevitably cut costs.