The Future of Clinical Trial Technology: Trends to Watch

Earlier this month, in a speech to Oxford University students, the former CEO of Microsoft, Steve Ballmer, said that the future is “cloud and devices”. In this case, the Sponsors of clinical trials should be looking to adopt technology solutions today as an investment in future efficiency and cost cutting measures. In this week’s blog post, ARITHMOS looks at technology trends that are shaping the clinical trial environment and offers solutions that can be implemented to start improving trial performance.

 

1. JOIN THE CLOUD.

cloudtrendsIf your company has not considered cloud-based technologies for clinical trial operations, it’s time to get on board. EDC systems, pharmacovigilance systems and reporting tools are offered in both Software as a Service (SaaS) and Platform as a Service (PaaS) mode meaning there is no installation or purchase of hardware or software which significantly reduces operational costs.

Cloud computing can increase employee productivity and collaboration since they can access the application from anywhere and communicate in real time via the application rather than meetings and emails.

Cloud computing can also be more secure than software and hardware installation. Service providers can ensure high levels of security, run security patches and perform validation and maintenance services.

Solutions for Clinical Trials: ARITHMOS can provide several cloud-based solutions for Sponsors of clinical trials. We have a cloud-based EDC system, Symphony, which simplifies data collection and management. eCRFs can be designed independently without particular need for technical skills. Additionally, ARITHMOS provides pharmacovigilance database and reporting solutions as Software as a Service (SaaS) meaning your safety data is available in real-time and in compliance with regulatory standards. ARITHMOS also offers clinical data reporting solutions in cloud mode so Sponsors can analyze study data and reports from multiple sources.

 

2. PICK YOUR DEVICE.

Approximately one in every five people worldwide has a smartphone, and 6% of the world’s population is using tablets which are demonstrating a faster adoption rate than smartphones. So, why not use smartphones and tablets in clinical trial operations?

The best example of devices in the clinical trial environment is smartphones and tablets as ePRO devices. ePRO takes the burden off the subject and allows clinical trial leaders to have more control over the situation. Devices can be programmed to send reminders to subjects so they fill out diaries with real time data and submit data in real time. Moreover, studies have demonstrated that subjects have a greater sense of privacy with ePRO devices. Subjects might be hesitant to respond honestly on a paper form knowing that various people will read their answers.

Lastly, clinical trial leaders no longer have to manage paper questionnaires with the risk of losing clinical data or having to interpret illegible responses.

Solutions for Clinical Trials: ARITHMOS has experience implementing ePRO systems using iPhone, Blackberry and Android as well as tablets such as the iPad and Samsung Galaxy Tab. These devices have proven to be intuitive and increase patient compliance as well as provide applications with medical and health related information. It is also possible to implement therapeutic area specific devices. ARITHMOS has used a spirometric device for respiratory trials and glucometers for diabetes trials.

 

3. CONTEXTUALIZE YOUR DATA

In 2014, there is no reason Sponsors shouldn’t have real-time access to clinical data in a clear way. Clinical data visualization tools are available to create efficient and customized reports. These tools manage vast amounts of data and present them in visual tables and graphs to simplify analysis and make important decisions about study progress.

Solutions for Clinical Trials: ARITHMOS works with the best Business Intelligence providers to offer a state of the art visualization tool. We can then integrate data visualization tools with your handheld devices for real-time access to clinical data anytime, anywhere.

 

4. BE SOCIAL.

pharmasocialmediaSocial media is a technological area that is still growing in clinical trials. How can Sponsors and Investigators connect directly with patients through various social media outlets such as Facebook, Twitter or even LinkedIn? Will there be a future social media hub just for clinical trials?

Social Media may also play a key role if the European Union moves forward with its data transparency initiative. How can companies present data in a clear and transparent way using social media tools?

Can social media eventually be used for signal detection and other pharmacovigilance needs?

Sponsors should begin analyzing the potential of social media and the impact it may have on clinical trial operations and marketed products.

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)

Why support more than one RDBMS (Relational DataBase Management System)?

The question should be obvious: why do I need to implement many lines of code and spend a lot of time supporting more than one database simultaneously?

In this blog post, ARITHMOS‘ Software Development Manager, Gaetano Giusto, discusses how you can support multiple RDBMS systems to control information storage and why you should invest the time and resources in doing so.

rdbms_icon

There are several answers to this question and are all correct in their own way. Obviously the main focus is to reach the most number of customers as possible and obtain the highest revenue selling your application. Nowadays there are several Operating Systems and a wide range of environments to support so you have to choose which one best fits your target customers’ needs.

It is difficult to say which is the best solution to develop because there are too many factors to consider and every situation is unique. The first thing to consider is that if you develop a solution which could support multiple applications such as Oracle, Ms SQL and MySQL alternatively, it could become really complex and require a lot of time in the analysis.

The second critical factor is the limitation you can encounter in supporting more than on RDBMS. In fact, not all RDBMS have the same performance level or the same enhancements, so you can probably assume the loss of some features that could be very useful.

Another thing to consider is that you need to develop more classes or a lot of code, and this could be frustrating if you consider that you have to fix bugs and develop specific functions for each RDBMS every time each vendor does some modifications.

If you can’t dedicate the time and resources to developing an in-house solution, you can think about an ORM – Object-Relational Mapping. This is a programming technique for converting data between incompatible systems in object-oriented programming languages.

ORM

ORM products (NHibernate, ADOEF), are well-tested before being released on the market. After all, these companies have a reputation to maintain, so you don’t have to worry too much about bugs. The chance of there being a bug in one of these frameworks is lower than any developer unwittingly creating a bug in his own data layer.

In conclusion, developing a solution that can support more than one RDBMS is quite difficult and requires more time and resources with respect to a single RDBMS solution. However, the most important factor to take into consideration is the market in which you operate. This solution can also help you reach a wider range of customers in order to sell your application, assuming you want to sell it. 

ARITHMOS Solution – Implementation of Applications

ARITHMOS Business Analysts support the key users in the definition of Business Requirements. During this phase, the key users are trained in the functionalities and standard workflow of the new system. In most cases, the user’s knowledge is limited to sales and pre-sales presentations, making a Business Analyst essential in this initial phase.

By using this approach, key users can deepen their understanding of how the system works and if it fits their organizational structure, proceseses and procedures. They can then define, together with the Business Analyst and technical experts, how the system should be configured. Knowing the system in the initial phase can reduce timelines and risks related to the operational target phase. Users who are trained and informed on the system adopt a proactive approach throughout the system implementation and qualification process.

Choosing an Efficient Pharmacovigilance System: the Critical Factors

photodune-2386650-human-lungs-in-digital-design-mPharmacovigilance is becoming a more pressing issue in drug and device life cycle, mostly due to increased regulations by the EMA and FDA 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 looks at the critical factors companies must consider when choosing a pharmacovigilance database and reporting system.

Is the system compliant with regulatory standards?

Is your company developing drugs or devices in the EMA? FDA? Or in the global market?

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 released good pharmacovigilance practice guidelines (GVP) which focus on “proactive and proportionate risk management”, higher quality of safety data and “strengthened transparency”.

Your pharmacovigilance system should be an up-to-date version that is validated and meets the requirements of computerized systems in the GCP environment.

Does the system have technologically advanced reporting tools?

Your pharmacovigilance system should have real-time reporting features in order to analyze safety data immediately.

  • Does the system have expedited reports for drug and device?
  • Does the system have detailed reports and dashboards to analyze workflow?
  • Does the system have support for ad hoc querying and reporting?
  • Can the system generate reports for case reconciliation?
  • Can the system report discrepancies between safety and clinical systems?
  • Can report data be extracted and distributed?
  • Can the system be integrated with other Business Intelligence reporting tools?

Is the system intuitive?

While the system itself may be complex in design, Pharmacovigilance Officers and Drug Safety Officers need to be able to use the system easily. Make sure the system has support for your pharmacovigilance workflow, case processing, case submission and reporting. Be sure your system provider has a HelpDesk service available for the more complicated functions.

Is the system available in the cloud?

The benefit to having your pharmacovigilance system offered as  Software as a Service (SaaS) is that it minimizes the IT effort and is easily accessible via web browser. 

Does the system have the appropriate coding functions?

In addition to supporting MedDRA and WhoDrug coding dictionaries, your pharmacovigilance system should have the ability to code all relevant data elements on a single screen.

Who will take care of the hosting, validation and maintenance?

When implementing a life sciences application like a pharmacovigilance database and reporting system, it is best to rely on technology experts. They can provide an analysis of user requirements and provide installation, configuration, validation and system maintenance in accordance with regulatory and ICT guidelines. 

The ARITHMOS Solution

argus safetyARITHMOS can implement a pharmacovigilance system as Software as a Service (Saas) with a standard validation configuration and customization applied to meet customer business processes and needs and ensure safety and comply with pharmacovigilance regulations.

As an Oracle Gold Partner, ARITHMOS can offer the Oracle Argus Safety Version 7 pharmacovigilance system, which is a native SaaS solution accessible via web browser. Argus is an ideal solution for managing a global workflow while providing case reports and instant safety data reports and analysis. The key functionalities are its easy-to-use interface, its system management, coding functionalities and reporting tools.

ARITHMOS can also migrate safety data from older, outdated and discontinued systems. 

Pharmacovigilance Day Germany – 2 April 2014 in Munich

ARITHMOS is sponsoring the first annual Pharmacovigilance Day – Germany edition which takes place on Wednesday, 2nd of April 2014 in Munich, Germany. The title of the event is “Designing an efficient Pharmacovigilance System: Integrating electronic systems to achieve an effective Safety System” and will highlight how the use of electronic systems can help companies achieve the appropriate safety system required by regulations, especially under the new GVP guidelines.

 For additional information or to register, visit the official event website

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