ePRO & EDC Integration: Good Practice Designs to Benefit Statisticians and Data Managers

StatisticsPaper Recorded Outcome diaries have been used in clinical research for over 30 years. With the introduction of electronic patient recorded outcomes (ePRO), studies have been conducted to assess the benefits. ARITHMOS discusses the benefits of ePRO and EDC and good practice designs which will benefit biostatisticians and clinical data managers.

The benefits to an ePRO and EDC integration approach are:

  • Less administrative and cost-effective
  • Quicker data cleaning process, reducing data management costs
  • Increase of patient compliance from 30% with paper to 90% with an electronic method such as devices
  • Real-time data so trial leaders can make more educated and adaptive decisions and intervene immediately if a problem occurs
  • Multi-language and global study data are in a single database
  • Market shifting towards user-friendly devices
  • Devices with “apps” allow access to study resources in a worldwide database

The integration of Patient Recorded Outcomes and Case Report Forms into Electronic Data Capture systems reduces the risk of trial delays by eliminating discrepancies which saves time and inevitably expenses and synchronizes data to offset conflicts in two isolated data sets.

Good Practice Designs

Integration should support data transfers in real time to eliminate the chance of outdated data sets and discrepancies. An integrated solution requires a central database to store data for all trial subjects, and security measures are in place to ensure confidentiality of data.

Integration requires an ePRO device with questionnaire, a connection (wireless, bluetooth, cable), HTTPS on the Internet, web server and a remote data capture EDC system. In terms of ePRO devices, the market is shifting towards individual, handheld devices which patients can use at home,. Smartphones and tablets are an ideal choice since they can be individually distributed with no assembly required, the questionnaire appears in the same format for every patient, data is submitted automatically and “apps” are available for download. 79% of physicians prefer the iPad for clinical use since new technology allows for diagnosis and tracking medical progress such as monitoring heartbeats and managing glucose levels.

ipadstudyTo give a specific example, ARITHMOS recently participated in an observational study validating questionnaires for over 300 patients on an iPad 2 tablet. ARITHMOS’ responsibility was to integrate the questionnaire data from the iPad with an open source EDC system allowing the data to be transferred into a clinical database. Questionnaires were made available in the Apple Store and patient data on the iPad was encrypted. Personal credentials were needed to access the questionnaire. The iPad was an ideal choice for patients due to its large screen and buttons, multiple language support, touchscreen and automatic score computation.

ARITHMOS constructed a web portal to receive, decrypt and forward the data to the clinical database along with a prompt alerting system for any unsuccessful uploads. The study database was set up and validated in the eCRF application according to the study protocol. Real time metrics were made available to the Sponsor for questionnaire data comparison during the study.

Additionally, training was available for Investigators and a three tier HelpDesk system was available for Investigators and site personnel including iPad support and maintenance.

Benefits to Statisticians and Data Managers

Statisticians

  • Study metrics are available up-to-date on eCRF
  • Automated and real time patient binding
  • Timelines: Blind Review Meeting and Database Lock possible only a few days after LPLV
  • Statistical Reporting is carried out in the short term; very low risk of blinding errors

Data Managers

  • Accelerated Query Management
  • Real time data transfer in eCRF during the study
  • Data Review in real time in eCRF
  • Real time checks for inconsistencies

Overall, clinical trial professionals should be considering the ideal ePRO and EDC integration approach for their next clinical study including a careful evaluation of ePRO devices available and EDC systems which best fit study requirements. ePRO devices should improve patient compliance and meet the study objectives. Besides smartphones and tablets, specific devices like spirometry devices for respiratory studies, can also be integrated with EDC systems. In terms of EDC, every study has its requirements including budget restrictions and study build and setup. Contact ARITHMOS for a full evaluation of study needs and support in making the best clinical trial technology decisions.

Careers in Life Sciences: Intern at ARITHMOS as Computer System Validation Specialist

???????ARITHMOS is expanding its team once again and looking for motivated and talented interns to join its group. ARITHMOS is hiring a Junior Computer System Validation Specialist to join its team as a paid intern in order to grow in the field of Computer System Validation within ARITHMOS.

ARITHMOS is committed to training the intern in applied computer system validation in the clinical research sector. This is a paid internship, which after 6 months has the opportunity to become a full time position as CSV Specialist, a role which manages validation activities and international regulatory standards in the pharmaceutical environment (21 CFR Part 11, Annex 11) as well as international validation guidelines (GAMP 5, PIC/S).

The role also involves various IT aspects with a particular focus on information security (Privacy), disaster recovery and Quality Assurance serving as a technical expert in case of regulatory inspections and client audits.

The primary responsibilities are:

  • Manage, plan and carry out activities in computer system validation for both the company and clients
  • Manage maintenance activities in computer system validation such as the change control process, periodic revision of validation status and revision of disaster recovery for critical applications
  • Update the IT operating procedures to guarantee compliance with company processes, international legislation and IT standards
  • Prepare and support clients before and during Regulatory Inspections

The ideal candidate will possess the following characteristics:

  • Highly motivated to develop a career in Computer System Validation and software quality
  • Good knowledge of Software Development Life Cycle
  • Working proficiency in English (or working proficiency in Italian if not a native speaker)
  • Good communication skills
  • Ability to work in a team
  • Energetic and determined

Knowledge of validation principles (GAMP 5 for example) is a plus.

main_image_careersAs an up and coming technology company with a niche in life sciences technology, ARITHMOS is always looking for the best talent to join its team. We seek candidates who are skilled in various IT areas, passionate about their work, work well in a team, and above all those who are flexible since ARITHMOS’ mission is to provide customized IT solutions to meet client needs.

To apply for this current internship position, please visit ARITHMOS Careers Page or send an email to hrcros@crosnt.com with “Candidatura ref. 13-006-CSV” in the subject line.

Careers in Life Sciences: ARITHMOS Looking for Database Administrator & Systems Analyst

arithmosARITHMOS is pleased to announce that is looking to expand its team of life science technology professionals in its Verona, Italy office. We are currently looking for a Database Administrator & Systems Analyst to join our highly motivated and expert team.

This role foresees the installation, configuration and maintenance activities of databases. Working closely with a Hosting Specialist and the Life Sciences Application department, the DBA & Systems Analyst will collaborate on writing procedures and defining user requirements, specific functions and updating and modifying current systems.

The primary responsibilities for this role include:

  • Administer and maintain databases including tuning activities and definition of maintenance scripts
  • Carry out diagnostic activities and manage application errors working with software developers to resolve any issues
  • Collaborate on the development and installation of data backup and recovery strategies
  • Provide support for written procedures (server configuration, security, disaster recovery and backup, scripts and stored procedures, monitoring, tuning and optimization methods)
  • Support the Software Development and Life Science Applications departments in the development of user requirements for software and applications, interpreting and documenting user requirements and defining the design procedure of applications
  • Interact with the Hosting Specialist to design and maintain the IT infrastructure
  • Evaluate new technologies to provide recommendations
  • Manage system documentation (installation and test protocols, technical specifications, user manuals, procedures, etc)

The ideal candidate possesses the following skills:

  • Degree in Information Technology, Engineering or related field
  • At least 3 years of experience in a related role
  • Prior experience in virtual infrastructure management (e.g. WMware, Citrix)
  • Good knowledge of backup and disaster recovery processes
  • Experience in server installation and configuration
  • Experience in installation, configuration and maintenance (including DB/tuning, PL/SQL issues, debug), database upgrade (Oracle database will be the preferred database) and other software
  • Good knowledge of tuning software, development and administration of databases (SQL Developer, PL/SQL Developer, Toad, Oracle Enterprise Manager, etc)
  • Basic knowledge of Computer System Validation processes
  • English language working proficiency
  • Good communication skills
  • Teamwork skills
  • Flexibility and motivation to meet goals

high-paying-tech-jobsAs an up and coming technology company with a niche in life sciences technology, ARITHMOS is always looking for the best talent to join its team. We seek candidates who are skilled in various IT areas, passionate about their work, work well in a team, and above all must be flexible, since ARITHMOS’ mission is to provide customized IT solutions to meet client needs.

To apply for this current job opening, please visit ARITHMOS Careers Page or send an email to hrcros@crosnt.com with “Candidatura ref. 13-018-DBA” in the subject line.

To what degree does Information Technology Influence Pharma Operating Strategies?

Pharma ITThe eClinical trial technologies market is set to reach $1.37 billion USD by 2018. The driving forces behind this surge are the pharma industry’s narrowing drug pipelines, expiring patents of popular drugs and the scarcity of prospective drug launches. Therefore, there is a need in the pharma industry to find tools that can accelerate the drug development process and boost productivity. ARITHMOS explores how IT tools are influencing operational strategies in the pharma industry. 

Why are pharma companies looking to implement life science technologies? Clinical trial technologies enable real-time data analysis, cut costs while optimizing the drug development process and are utilized to make “go/no-go” decisions quicker. However, there are different needs for different market sectors such as large pharma, small to mid-size pharma (SMB), biotechs, academic and hospital research centers and CROs.

Let’s look at the similarities and differences for large pharma vs. SMB pharma; IT needs include:

  • Compliance with Regulations: adapting a risk based approach, shortening the validation effort
  • Costs: low cost/open source solutions, effective project management
  • Technology Solutions: support for technology selection, technical support and maintenance, external hosting solutions
  • Flexibility: Customization, easy-to-use clinical applications, integration with other systems/devices
  • Efficient Processes: solutions to streamline internal processes

The SMB market sector, however, faces challenges in implementing IT solutions. They often have a lack of expertise, training and finances for technology upgrades which leads to limited adoption of IT solutions. SMB, compared to large pharma, does not have economies of scale to exploit the building of informatics system solutions.

In addition, SMB companies are affected by the risks of various failure scenarios such as: creating a system they can’t afford to validate, creating a system that is unable to grow with the company, or creating a system that is too costly to maintain.

All of these factors influence how a company integrates IT into an operating strategy. The solution is to engage the support of an IT supplier which can provide:

  • Business Requirement Analysis
  • Selection of appropriate eClinical Solutions
  • Consultancy for the implementation, validation, support and maintenance of the chosen solution
  • Hosting model/SaaS
  • Integration with other applications (ePRO/EDC integration)
  • Providing customized reporting
  • End User Training (e.g. eLearning)

Let’s look at an example of this strategy put into practice. Generally, researchers don’t want to spend much time finding data management solutions or solving technology support problems. They would rather spend their time doing research.

Therefore the high level EDC business requirements would be defined as: low-cost, web-based, ease of designing CRFs including automated error detection, scalable and the availability of training materials and documentation.

Proposed Solution

Investigator PdaPharma companies, especially those in SMB category, can implement a customized EDC application. ARITHMOS has a proprietary EDC system called Symphony which works under the SaaS (software as a service) model. It is an intuitive EDC platform ideal for Investigator’s basic needs and provides customized reporting tools using SAS programming. HelpDesk is available 24/7 via an online ticketing platform or a toll free number for Investigator technical support.

A customizable life science technology solution is appropriate in this situation because the Sponsor is paying for the functionalities needed and not paying for those not applicable to the study. The Sponsor and site personnel can use the same application for different projects and reuse the application with slight modifications. Therefore, training efforts are kept to a minimum due to high usability.

Are study goals reached?

This customized EDC solution allows for published study results with a high impact factor. The study data is reliable and available in real-time. Finally, there is a reduced effort in technology on the part of Investigators and site personnel allowing them to increase time spent in clinical research activities.

For more information on customizable IT solutions or to consult with ARITHMOS on implementing IT into your clinical trial strategy, contact us at info@arithmostech.com.