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18 Sep 2020

San Antonio-based software company is changing the face of the clinical trial industry

San Antonio-based software company is changing the face of the clinical trial industry

RealTime Software Solutions is introducing DecenTRIAL, a site-friendly decentralized study platform that allows Sponsors and CROs to manage clinicals more efficiently, remotely and without the need for costly EDC systems.

San Antonio, TX – In a world becoming more and more virtual, sites, sponsors and CROs are scrambling to find solutions that allow clinical trials to continue uninterrupted. One San Antonio-based software company is proving that they can do just that.

“RealTime DecenTRIAL is an innovative solution that will ultimately change the way the clinical trial industry does business,” says RealTime Software Solutions CEO, Rick Greenfield. “The system streamlines operations by offering an all-in-one solution that provides sites, sponsors, and CROs access to needed clinical trial documents and data remotely while improving site efficiency, lowering trial costs and improving quality and patient safety.”

The clinical trial industry has relied heavily on paper to collect critical trial data leaving room for error and adding high overhead costs to both the sites and sponsors.

“Many sites are still using paper systems, and even those are using electronic paperless systems are still having to transcribe source data into EDC systems,” says Greenfield. “This means that sites are doing more work and the sponsor has to verify all source data either on-site or remotely and in-turn, pay for electronic data capture (EDC) systems. This process comes at a high cost for sponsors, which would be eliminated by utilizing our DecenTRIAL system.”

Though many sites and sponsors alike have been slow to adopt new systems, the coronavirus has forced the industry to look at electronic systems in a new light. Experts say that the change will only help to accelerate the clinical trial process.

Benefits to the DecenTRIAL system include greater efficiency in all phases of the trial process for both sites and sponsors, real-time data delivery, instant data review from any location, and substantial cost savings. This includes access to source and regulatory documents through a virtual monitoring portal and built-in query access.  The system is also GDPR, HIPAA and Part 11 compliant with complete audit trails and data controls.

“It’s not just about saving money by eliminating the need for EDC,” says Greenfield. “Our system is about efficiency and streamlined processes that essentially remove the need for on-site data verification and outdated paper data collection.”

To learn more about RealTime-DecenTRIAL, visit RealTime-CTMS.COM or call 210-852-4310.

About RealTime-CTMS

RealTime Software Solutions, LLC is a leader in cloud-based software solutions for the clinical research industry and is dedicated to solving problems and providing systems that make the research process more efficient and more profitable. We are constantly listening to our customers and to the needs of the industry to provide new innovations that streamline processes and help us all achieve our operational goals. RealTime’s focus on exceptional customer service ensures that all clients get the most out their RealTime solutions.

CONTACT:

RICK GREEFIELD, CEO

RGREENFIELD@REALTIME-CTMS.COM

210-386-4201

09 Sep 2020

RealTime-DecenTRIAL: What You Should Know

As our industry shifts to paperless systems, virtual visits, and remote-monitoring, Sites, Sponsors, and CROs must pivot to what is now considered the new norm or business-as-usual.  This transition has encouraged a complete re-thinking of processes and procedures to ensure compliance, efficiency, budgeting and profitability.

RealTime’s vision highlights our continued commitment to reshape the global clinical research industry with innovative solutions. That is why we are excited to announce RealTime-DecenTRIAL, a new way for Sponsors and CROs to manage clinical trials centrally. RealTime-DecenTRIAL allows complete connectivity and real-time remote monitoring for sites while delivering world-class eSource and eRegulatory systems for rapid data and document collection.  DecenTRIAL also supports virtual visits and will soon have eCONSENT built in for even greater convenience.

Key features of RealTime-DecenTRIAL:

Site-Centric eSOURCE

RealTime is an industry leader of site-focused systems proven to bring greater efficiency and improved compliance to sites.  Not all eSOURCE is equal, so putting a site-focused product into the hands of investigators and staff will help ensure success at the site level for your study.

Data Management without EDC

In paper-based trials, data is collected on paper and transposed into EDC.  Not only is the transposition process a lot of work for the sites, but there is also a lot of room for error.  As a result, time-consuming source verification is required by CRAs to ensure that each data point in EDC is an accurate representation of the source collected at the patient bedside.  With DecenTRIAL’s eSOURCE, no transposition is required; source data can be risk-based monitored remotely and rolled up into a final data file for final analysis. DecenTRIAL ultimately saves both sponsors and CROs unprecedented amounts of time and money!

Remote Portal Access and Built-in Query System

Online access allows monitors and research staff to collaborate more effectively during the study. Monitors can quickly review, track, and query records within the monitor portal. This accelerates the monitoring process and provides for real-time oversight of data, compliance, and safety. 

Compliance and Data Integrity

We have you covered with data privacy compliance (GDPR and HIPAA), as well as Part 11 Compliance for computer systems. Complete audit trails and data controls prevent human errors during data collection while improving data quality.

We build the eSource

Our trained eSOURCE specialists will create and maintain your electronic documents to ensure accurate data collection.

Win-Win Solution for Sites and Sponsors

Our system increases site adoption by satisfying the end-user (Study Coordinators and Investigators) while providing Sponsors the data they need; faster, cheaper, and compliant.

Free yourself from the constraints of paper data collection and the time, expense, and inefficiencies of EDC systems. Get started with a new way to manage your trials.  Schedule a free demo today and discover what RealTime-DecenTRIAL can do for your clinical research operations.

27 Aug 2020
realtime clinical trial software - elise

Behind the Software with Elise Tawfiq

At RealTime, our mission is to strive for the complete success of our customers every day. By accomplishing this, we have dedicated our time to finding strong individuals to help shape tomorrow’s clinical trial software.

RealTime is dedicated to providing exceptional support, which is why we search for team members above and beyond our customers. Our goal as a team is to give back to clinical researchers by creating software that is more efficient, reliable, and easy to use. This month, we feature our amazing Sales Director, Elise Tawfiq.

Since 2015, Elise has been a huge part of the RealTime family. With over 15 years of experience in the clinical research industry, Elise has helped shape the company by bringing exceptional value and industry knowledge to the team. In an interview with Elise, we asked her some fun questions to get to know her better!

Do you have a favorite holiday? Why or why not?

Thanksgiving. Food, Family and Football

What’s one work-related thing you want to accomplish in the next year?

To assist more sites, sponsors, and CROs in leveraging technology in new and innovative ways and to lead the way in the development of solutions that will bring together the efforts of all these players in the game.

What was the last TV show you binge-watched?

Grace & Frankie

What’s the phone app you use the most?

Amazon

What’s the career highlight you’re most proud of?

I am most proud of the opportunities that I have had to assist patients that do not have easy access to healthcare or may lack insurance by aiding them in getting proper testing and ongoing treatment.

If you could go back to anytime in history, where would you go? 

I think it would be amazing to go back to the Mesozoic Era and see a living dinosaur.

What’s the first job you’ve ever had?

Ticket Sales at Sea World

If you could only eat one food for the rest of your life, what would it be?

That is hard one to answer because I really love all types of food.  It would probably be Bahn mi sandwiches!

What’s your favorite way to spend a day off?

With my friends and family relaxing preferable by a lake, river, or pool.

What is the thing you like most about your job?

Connecting with clinical research professionals across the globe.  Listening to their successes, struggles, and working with them to provide out the box ideas to solve problems create growth within their organization.

Thank you, Elise, for your commitment and dedication to helping RealTime customers be successful. Stay tuned for more of employee highlights on RealTime’s Behind the Software series!

07 Aug 2020

Transition and Adaptation of Clinical Research in 2020

Wow… 2020 has been a year of adaptation on a level that none of us could have predicted.  As we celebrated last New Year’s Eve with the excitement of what 2020 would bring, none of us knew what we were in for!

But here we are, proving that we are even more resilient than we ever thought we were.  I am sure we all had thoughts in April/May of “are we going to get through this?”, and yet we have!  But what is even more interesting is that, in many cases, I think we have thrived!  This has been a time to tap into innovation and adaptation to find new, different, and better ways to get things done.

I am excited about how we will have grown when we are fully on the other side of this pandemic.  I think that not only will we be able to reflect on our own businesses and see vast process improvements, increased efficiencies, and innovative new tools that will ultimately make us much more profitable; but we will be able to see industry-wide changes that are going to transform how research gets done permanently.

Perhaps we could even say that Covid-19 was the kick in the rear that we all needed to accelerate long-overdue changes.  The paperless systems that we are all scared to adopt are now being adopted almost as a new standard.  The acceptance of these systems by Sponsors and CROs is widespread, with a wonderful side effect of actually loving how these systems provide for greater oversight, risk-based monitoring, reduced monitoring costs at least as it relates to travel, and more.  Sites are finding that these systems allow for more efficient data collection, regulatory processes, investigator oversight, staff communication, remote operations, and improved data and process quality control.

It’s almost sad to think that it took a global pandemic to make our industry innovate and transition into systems that were already readily available that were waiting to provide the value that we are all experiencing only months later. Still, perhaps we can be happy that we have come this far and hope that we have learned from the experience. Maybe now we will all seek these opportunities to adopt technology and innovation faster and more openly.

RealTime is not going to stop innovating.  We will continue to look into the future and build systems that will help us get there.  We will be listening to our customers today and customers to-be to understand their challenges, and we will be here to solve them.

While 2020 has been a crazy year and emotions have been high, perhaps there are at least a few reasons to appreciate what we are working to overcome and how much stronger we will be when it is over.

Here’s to 2020!

Rick Greenfield, CEO

10 May 2020

Tips for getting sponsors to cover your site-based electronic systems

With more and more research sites adopting site-based electronic systems, such as RealTime-eDOCS (eRegulatory) and RealTime-eSOURCE, it’s important for these sites to ask, “Am I leaving money on the table?”. Due to the value that these systems bring to the research process, it’s now more common than ever for sites to obtain payment from sponsors to cover the cost. While negotiation methods can vary from site to site, budgeting for these systems in your CTA with the sponsor/CRO is justified by the benefits gained by all parties.

Site-based systems offer greater efficiency in data collection processes, increased access to critical records, and an overall reduction in the costs of regulatory and data management. One example is virtual monitoring, which offers sponsors/CROs remote access to data records anytime and anywhere. This access saves tremendous travel costs. Virtual monitoring is also helping facilitate risk-based monitoring which helps sponsors/CROs better utilize staff and resources to manage trials.

Sites, sponsors and CROs are not the only ones to benefit, study participants experience streamlined engagement through virtual visits, telemedicine, electronic questionnaires and eConsent. With increased efficiency and remote access to records, investigators can focus more time on patient safety and patient retention.

When adding payment for these systems to your CTA, you may find that certain approaches work better than others. When adding a new “systems fee” to the budget, RealTime offers a justification letter that sites can send to the sponsor to showcase the value of the system. This approach can be very effective once the sponsor sees the benefits they receive in return for payment. If this approach isn’t effective for your site, other sites are successful building these costs into existing budget items. With eRegulatory, your existing archival and startup fees will already cover the cost since you are streamlining startup processes and no longer storing paper records. Even though these fees cover partial/full cost of the system, it’s good to try increasing these fees to further offset the cost of the system and receive fair payment for the cost of doing business. For eSource, many sites are successful by simply increasing their per visit revenue by as little as $10 per visit. With this tiny increase in visit revenue, RealTime customers ultimately get eSource and CTMS paid for on that particular study. Many RealTime customers also have a general overhead fee that is charged on top of the budget. From RealTime’s experience, this fee can range between 3-25% and is a great way for sites to cover costs that aren’t directly budgeted for in the CTA.

To summarize, RealTime is seeing more and more customers utilize site-based electronic systems in research and can obtain payment from their sponsor. With the clinical research industry moving more towards virtual visits, telemedicine and virtual monitoring, these systems offer all parties numerous benefits. Each site is finding creative ways to negotiate payment for these systems in their CTA. So again, are you leaving money on the table?