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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Guide to Selecting an EDC System: Cost vs Functionality Matrix

When it comes to selecting an EDC vendor, it seems that most vendors fall into one of two categories: advanced technology and competitive pricing or moderate to baseline technology at a low cost. While budget is a major concern for most Sponsors, how can they be sure they are choosing the right technology to produce the best study results? ARITHMOS has put together a cost vs functionality matrix followed by a list of considerations for selecting an EDC system for your next study.

EDC

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Considerations

1. Cloud-based Technology

An EDC solution provided in Software as a Service (SaaS) cloud computing mode can improve the drug/device development process in terms of greater efficiency, a better decision-making process and cost-cutting measures. Sponsors can resolve discrepancies faster and reduce time and costs with immediate feedback from patients. A cloud solution can organize multi-language, global study data into a single database, improving the quality of data through automated edit and discrepancy checks and faster data cleaning.

2. Support Level

What is your ideal level of support for an EDC system? The more advanced systems provide excellent initial training programs and top level support through HelpDesk and study guidance. The baseline technology systems allow the Sponsors to work more autonomously with regards to study build and management. However, in this case the user interface needs to be intuitive and easy to navigate.

3. Hosting and Licenses

Consider how you will manage the EDC license and hosting options. Some systems include this in an inclusive package and others will provide various “à la carte” options.

4. Integrated Platforms

Some EDC systems are part of a larger integrated platform for seamless data integration among ePRO, CTMS, IRT and other clinical research systems. Falling into the advanced technology, competitive pricing category, an integrated system may be worth the investment for your program of studies.

clinical-trial-deviceLastly, don’t forget your functionality checklist while evaluating EDC systems:

  • Can you build your own study?
  • Are there data entry, coding and randomization features?
  • Are there Project Management tools?
  • Are there customized reporting features?
  • Are there re-usable templates and forms?
  • Is the system compatible with GCP and/or regulatory guidelines? Is there an audit trail?
  • Can the system handle multicentre, global studies?

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.

Evaluating eCRF Needs for Medical Device Trials: the Cloud-Based Approach

What are the needs of medical device companies when it comes to eCRF and EDC systems?

clinical-trial-deviceAt the end of 2013, the European Union passed legislation for a new approval process of medical devices going to market that mirrors the process in place by the FDA. The European Union has responded to recent medical device scandals, for example the breast implant incident in France which claimed several patient lives, and is pushing for regulations that increase patient safety. ARITHMOS discusses an eCRF solution to support medical device companies.

To give a brief outline of the changes:

(1)    The equivalence principle will no longer be admissible. Companies can no longer simple demonstrate that a device is equivalent to another device already on the market. Medical device companies will need to perform more sophisticated trials and collect additional data to demonstrate efficacy and safety.

(2)    The EU is proposing more post-market follow up studies and safety surveillance

(3)    Similar to drug trials, the EU is also pushing for greater data transparency meaning trial data needs to be available in a clear, reliable and traceable way.

For medical device companies, this proposed legislation means more trials and additional costs.

Which technology solutions can help medical device companies stay within budget and still obtain high quality data results in real time?

Technologies such as EDC and ePRO can help keep costs under control, especially if there are low-cost options. Incorporating an EDC solution into your medical device trial can provide immediate feedback, more accessible trial information, and higher data quality. It can facilitate an adaptive approach, or in the case of a trial that is showing a negative trend, it can allow for early termination, thereby reducing the risk to patients and reducing the cost of the trial.

An EDC solution provided in Software as a Service (SaaS) cloud computing mode can improve the medical device development process in terms of greater efficiency, a better decision-making process and cost-cutting measures. Health Sciences applications allow users to only pay for functions they use and to re-use certain applications for various projects.

How can a SaaS solution benefit medical device trials?

–         Sponsors can 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.

–          A cloud solution can organize multi-language, global study data into a single database. This is especially beneficial to statisticians who need up-to-date study metrics.

–         Improves the quality of data through automated edit and discrepancy checks, faster data cleaning, audit trails and compliance with GCP and regulatory guidelines.

The ARITHMOS Solution

meddeviceARITHMOS has a SaaS, cloud based platform called Symphony EDC, who possesses the basic functions of an EDC system that satisfy the normal requirements of Investigators. Symphony is a customizable Life Sciences Application which provides the following advantages for medical device companies:

– Paying for the functionalities needed and not paying for those not applicable to your study
– Ability to reuse the application with slight modifications
– Reuse of documentation
– Training effort kept to a minimum due to high usability
– Sponsor and site personnel use the same application for different projects

ARITHMOS to Host eCRF Symposium in Italy

ARITHMOS is hosting a symposium on eCRF requirements for institutions such as medical device companies, academic research organizations and hospitals. The symposium will present affordable and reliable eCRF solutions as Software as a Service.

The event will take place on Thursday, 10th of April at the University of Milan-Bicocca in Milan, Italy.

For more information, visit our website.

Medical Device eCRF Needs Focus Group

ARITHMOS is currently looking for professionals in the medical device sector to participate in a focus group on the current eCRF and EDC needs in medical device trials. We are looking for professionals in Europe or the United States who are involved in the CRF design and implementation for medical device trials. Participants can connect to the focus group remotely. If you meet the criteria and are interested, please send an email to info@arithmostech.com

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.

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. 

EDC Use on the Rise Despite Technology Implementation Concerns: an Overview

smart doctorThe global e-Clinical trial technology market is expected to reach $1.37 billion USD by 2018. Currently around 15% of newly initiated trials are using technology. Electronic Data Capture (EDC) is the fastest growing technology being adapted in the clinical trial environment despite concerns over efficiency. ARITHMOS discusses overcoming these concerns and why Sponsors should evaluate EDC options for their next study.

The United States and Western Europe have generally been the largest adopters of EDC technology. The U.S. eClinical trial technology market alone is growing 23% annually. The market is also shifting towards other geographical locations which can provide low cost, efficient solutions.

The main driver for adopting technology is the pressure on pharma, biotech and medical device companies to improve productivity, accelerate the drug development process and, of course, cut costs. There is an increasing number of clinical resources passing from preclinical to clinical trial phases, and study leaders need to be able to validate and analyze data in real-time in order to make crucial decisions.

Despite the numerous benefits – such as increased patient compliance, quicker data cleaning and real-time data – clinical trial leaders are still hesitant to adopt EDC technology. Many fear there is an added workload including double data entry, EDC edit check and technological implications. Clinical trial leaders believe that technical problems, such as complications with the actual system of lack of training and knowledge, can lead to time consuming activity.

The scope of EDC can also include the integration of an ePRO device. Another barrier to EDC/ePRO use has been the intuitiveness of devices used. While most people are comfortable using PCs, fax machines, scanners and email, many incorporating new devices such as smartphones and tablets can be challenging and require training and a different mindset.

Despite concerns, why should Sponsors still evaluate EDC solutions for future studies?

LearnThe availability of integrated data can enhance the overall drug development process through greater efficiency and effective decision-making. With adequate training and HelpDesk resources to provide continuous technical support, Sponsors should feel at ease implementing EDC technology. The main benefits include:

1. Immediate Feedback: Sponsors can resolve discrepancies faster and reduce time and costs with immediate feedback from patients. Data can be transferred in real time during the study into the eCRF. Query management is accelerated, and any inconsistencies in CRF or ePRO data can be checked in real time.

2. More Accessible Trial Information: An EDC solution can organize multi-language, global study data into a single database. Biostatisticians can receive up-to-date study metrics and statistical reports can be carried out in the short term with low risk of data blinding errors.

3. Higher Data Quality: Data is stored in an encrypted mode preventing data from being changed, deleted or modified. The data cleaning process is faster with Alert and Query Managers and edit and discrepancy checks are automated.

ARITHMOS also knows that one EDC system does not fit all studies. EDC selection can vary based on study phase, therapeutic area, patient enrollment and budget. Consult Arithmos for your next study to decide which EDC system or EDC/ePRO integration solution is best for your study.