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?

What are the eCRF requirements for low-budget studies?

designer_genes_featureOrganizations that conduct clinical research are constantly facing the challenge of maintaining a high level of quality data while working with tight budgets. The “non-profit” organizations such as academic research organizations, hospitals, associations and foundations are seeing a decline in the number of studies being conducted. Even companies in the biotech, medical device and small to mid-size pharma sector face budget restrictions or lack of funding, and therefore are limited in the research they can conduct.

Therefore, the outcome seems to be an increase in “low-budget studies”. In this case, what are the requirements for eCRF and EDC systems? Do they vary by industry? ARITHMOS looks at these factors in anticipation of its upcoming event – “eCRF Symposium”.

Even if the study budget has been defined as “low budget”, many companies and organizations can still implement eCRF and EDC systems that meet their budget and study requirements. What are the requirements that companies should be looking for in an EDC system?

Does the system have a pay-as-you-go option?

There are EDC systems that allow you to pay for the functions used and on a pay-as-you-go basis. This is ideal for non-profit organizations and small companies who really need to micro manage their budgets.

What is your functionality checklist?

  • 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 regulatory requirements?
  • Can the system handle multicenter, global studies?
  • Can the system be integrated with ePRO?

At this point, study Sponsors can cross check their study requirements with budget requirements. Is there a system that covers my requirement checklist and has a pay-as-you-go option? (See ARITHMOS’ Symphony EDC system)

There are, however, additional factors to take into consideration when determining eCRF and EDC needs which can factor into overall budget.

How long does implementation take?

Is implementation time a driver in your overall decision? The system provider should perform a user requirement analysis and determine timelines for implementation that fit your study timelines. Any delay in the study could also effect your budget.

What additional services does the system provider offer?

If price is the main driver in your EDC selection, there are additional factors that could increase your costs if they are not considered beforehand:

  • Does your system provider offer hosting and backup services?
  • Is training available by the system provider?
  • Is their technical support available in the form of a HelpDesk?

While low-budget studies might all consider price the main driving force behind an EDC decision, each sector most likely has its study requirements that need to be compared to price requirements. For example, do Academic Research Organizations require the same functions in an EDC system as medical device companies? Once a budget is defined, which factors become the main drivers – implementation time? Primary functions? Intuitiveness? Accompanying services?

ARITHMOS’ eCRF Symposium (Simposio sulla Scheda Elettronica) aims to distinguish eCRF needs in various industries and find the commonalities and the differences. The symposium, which takes place on the 10th of April in Milan, features a panel of speakers from academic institutions, hospitals and CROs to discuss individual sector needs and what is missing. 

SIMPOSIO SULLA SCHEDA ELETTRONICA (ITALIANO)
eCRF Symposium (ENGLISH)

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

5 Ways Academic Research Organizations Can Cut Clinical Trial Costs

HealthcareAcademic Research Organizations (AROs) face one specific challenge in performing clinical research: strict budget requirements.  AROs usually secure funding from the institution itself, private foundations or even government funding, however with economic downturns and budget costs, AROs are finding it increasingly difficult to secure the appropriate funding for research. Many have partnered with large pharmaceutical companies to bring new drugs to market, but in this case, the university usually takes on a CRO role performing data collection and analysis activities to help the pharma companies cut costs. 

To maintain the integrity of original academic research, ARITHMOS has identified 5 potential ways to cut clinical costs implementing basic technology solutions.

  1. Go Paperless. By now, even AROs can recognize the benefits of EDC vs paper. Besides higher data quality, better patient compliance and real time results, using electronic data collection can significantly reduce costs. Those evaluating the clinical data will have access to data in real time and can make decisions that will reduce trial timelines. The financial benefit of EDC systems is that they produce an overall better Return on Investment in terms of quality and efficiency.
  2. Enlist an expert to define requirements. You’ve made the decision to go paperless, now consult a technology/EDC expert to define user requirements for your organization. Technology business analyst with expertise in life sciences suggest time-saving and cost-cutting measures and make sure your system is compliant with Best Practices and regulatory requirements.
  3. Select an EDC Vendor Wisely: While you’re primary concern may be budget, consider the intuitiveness and operational effectiveness of EDC systems as well as possible integration with ePRO devices. These are all requirements to define in the evaluation phase which can save costs in the long run. Lastly, be sure your EDC vendor provides technical support to prevent cost consuming errors.
  4. Join the Cloud. Consider EDC and pharmacovigilance solutions offered in cloud computing mode – or Software as a Service (SaaS). Cloud solutions can offer scalability, flexibility, self-service and pay-as-you-go options. This allows clinical researchers to pay for the functionalities needed and not pay for those not applicable to the study.
  5. Consider eLearning. Any time a new technology is implemented, training is needed for all users. Rather than factoring in travel and logistical expenses for training purposes, ask your technology provider for an eLearning solution that can be completed in-house and at the user’s pace. This will not only reduce the training budget, but will increase compliance.

ARITHMOS SOLUTION

ARITHMOS caters to the requirements of AROs by defining user requirements that meet strict budgets. As your technology provider, an expert business analyst will define user requirements and provide complete technical support.

ARITHMOS has an EDC solution specifically tailored to the needs of AROs. Symphony EDC is a simple, easy-to-use, intuitive EDC system that has the main functionality of EDC as is relatively inexpensive. This EDC platform is available as Software as a Service and is therefore customizable and with payment options that reflect the functionalities used. Training can be done by academic leaders directly to the end users.

For more information, visit http://www.arithmostech.com or http://www.symphony-edc.com.

ARITHMOS Announces eCRF Symposium for Cost-Effective Studies

doctechPharmaceutical and biotech companies are constantly facing challenges in the drug development process including tighter budgets and the need for higher data quality and accessible, real-time results. Academic research – including studies conducted by academic institutions such as universities, non-profit organizations or research hospitals – often face an uphill battle when it comes to clinical trial funding, trial design and meeting deadlines. The result is that the percentage of trials being conducted in an academic setting is actually decreasing. 

ARITHMOS is hosting a seminar on cost-effective eCRF/EDC solutions in Milan, Italy on Thursday, 10th of April. The seminar will demonstrate how even low budget studies can implement eCRF and EDC solutions to run more efficient trials and facilitate data collection and analysis.

This seminar was created based on the idea that cloud technologies and Software as a Service (SaaS) technologies are becoming an ideal solution for clinical trial professionals. A SaaS electronic data capture (EDC) solution can enhance the overall drug development process in terms of greater efficiency, effective decision-making and, most importantly, cutting costs. Life science applications offered in SaaS mode allow users to pay for functionalities needed, the ability to reuse documentation and the ability to reuse the application with slight modifications for different projects.

During the seminar, ARITHMOS will present Symphony, an EDC platform that is simple, inexpensive and has the basic features of an EDC to meet the requirements of Investigators. Symphony is offered as Software as a Service (Saas), meaning the organization can work independently to set-up the study and build the database.

The speaker lineup is still being finalized, however the seminar will feature an expert panel of clinical trial professionals in the academic and pharma sectors who will discuss increasing efficiency, producing higher quality data with real-time results and improving timelines while staying within budget.

   The eCRF Symposium is sponsored by ARITHMOS and the University of Bicocca-Milan. All participants are invited to a light cocktail reception after the presentations; the seminar is free of charge but spaces are limited. For more information or to register:

eCRF Symposium and Symphony EDC (English Version)

Simposio sulla Scheda Elettronica: Symphony EDC (Versione Italiana)

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.