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Category: eSOURCE

30 Jul 2021

5 More Things to Look for in an eRegulatory System

As technology evolves, so must we. We can’t settle for the same technology just because that’s the system we’ve always used. In our previous blog, “5 Things to Look for in an eRegulatory System,” we discussed what to look for in an eRegulatory system for clinical trial management. User experience, a monitoring portal, secure centralized filing, compliance with Part-11 and HIPAA, and customer support are still as important as ever, but technology has evolved since then – and so have we. So here are 5 more things to look for in an eRegulatory system.

Online and Mobile Signatures

Don’t waste valuable time printing out documents, signing them, scanning them, and sending them back. With RealTime’s eDOCS, you can sign your electronic regulatory documents on your computer or even in our mobile app. In fact, RealTime is the first eRegulatory system to go mobile with unique features such as fingerprint technology for eSignatures and managing signatures electronically.

Remote Audit Readiness

Maintaining audit readiness is crucial to limiting unexpected setbacks, but so many factors go into preparing for audits that it can seem daunting. With eDOCS, you can remotely manage important documents, vendor and technology qualifications, employee training programs, employee feedback programs and so much more. This way, you won’t have to scramble to collect all the necessary information should an audit arise.  (You can read more on audit readiness here.)

Collaboration Capabilities

The eDOCS cart lets you group documents for easy sharing and bulk signing. Instead of tracking colleagues down individually or trying to find a time for everyone to fit a meeting into their schedule, you can now simply collaborate in one shared portal.

Email Integration

RealTime’s proprietary Outlook add-in provides the ability to drag and drop documents and emails directly into your eRegulatory binders. Don’t waste time searching for the right folder anymore.

Cost

Streamlining your clinical trial management shouldn’t come at the detriment of your budget. With RealTime, you get more of the features that set your trials up for success with less of the cost. There’s no obligation to pre-purchase studies. Sign up for a free demo today.

 

26 Jul 2021

Behind the Software with Rob Edwards

Our dedicated team of RealTime experts go above and beyond to provide world-class software packed with innovative features that provide unparalleled efficiencies for customers while providing an intuitive interface that’s easy to learn and use.  RealTime team members are aligned with one primary goal…  the success of our customers.  Each month we are excited to showcase one of our outstanding RealTime team members in RealTime’s Behind the Software series. This month, we are featuring one of our outstanding CTMS Product Specialists, Rob Edwards.

Rob joined RealTime in March of 2021 as a Success Team Specialist. He was quickly promoted to a Product Specialist in May, where he helps to apply the voice of our customers into new software developments that will lead to future enhancements within RealTime-CTMS. A typical day for Rob includes software validation testing, UX analysis, and customer support!

Now it’s time to go Behind the Software to learn more about Rob!

So Rob….

What is your hidden talent?

I can repel from helicopters and am a dad!

What is your go-to emoji?

😊

What was your first job?

I was a busboy at age 13!

What is at the top of your bucket list?

Visiting all of the countries in the world! 23 down, however many left to go!

If you could go anywhere in the world, where would you go?

Christ Church, New Zealand

What television show are you currently binging?

Community

What is your favorite movie?

Guardians of the Galaxy vol. 1

Do you listen to podcasts? If so, which is your favorite?

Yes, Joe Rogan like everyone else.

What is a new skill you picked up during the pandemic?

Pulling information from Twitter, Facebook and Instagram APIs

If you were a Late Night talk show host, who would be your first guest and why?

Chris Pratt. He’s so hot right now.

What do you do for fun outside of the office?

I play video games, scuba, spear fish, boat, play guitar, watch television, and PLAY WITH MY DAUGHTER!!!

What is your go-to karaoke song?

“Let the Bodies Hit the Floor.” Just kidding. . . but I really do it.

What is your favorite part about working for RealTime?

I love the culture! The work we do is ground-breaking to the industry; we are actually helping to save lives!

 

 Thank you for going Behind the Software with Rob! If you would like to learn more about how RealTime systems can help your company prosper, contact RealTime by calling (210) 852-4310 or complete this short contact form.  One of our team members, like Rob, will be happy to provide a demonstration of RealTime systems.

24 Jul 2021

ESOURCE Document Building with RealTime Keeps Your Sites Ahead

As new studies are coming up at your site, there is a lot to think about and prepare for.  Getting studies set up in your CTMS for visit and financial tracking is one important process but building great source to drive excellent data collection processes is another major hurdle to being ready to execute.

eSOURCE has paved the way for faster, more efficient source building to include advanced data checks, user delegation management, and other ALCOA-related checks and balances.  Ensuring that your eSOURCE is of high quality and meets industry standards requires a lot of time and effort from your staff and can take them away from more important activities necessary to successfully conduct currently enrolling and ongoing studies.

Keep reading to find out how our eSOURCE document building service can help.

RealTime has an eSOURCE Document Building Team that will:

Save Your Staff Precious Time

Building eSource documents requires breaking down lengthy protocols and EDC requirements for each study. With RealTime’s eSOURCE document building service, you can free up the time spent on building eSOURCE by utilizing our trained professionals so CRCs can focus on visit execution. 

Increase Your Profitability

While RealTime is building eSOURCE for your next study, your skilled staff can be producing.  Whether enrolling more subjects, conducting more visits or devoting extra time to other study start-up activities, your team can focus on important tasks, ensuring your site is ready to initiate on time.

Better eSOURCE!

The RealTime Team will build your source to help ensure that the protocol is followed, all EDC data points are captured, GCPs are upheld, and regulatory compliance is maintained.  The RealTime Team is made up of industry professionals trained in the art of building great eSOURCE by prior CRCs and QA Managers of leading sites.

RealTime’s eSource document building service is not only great… it’s affordable!

Call or email RealTime today to get an eSOURCE building quote for your next study.

28 Jun 2021

Behind the Software with Chris Jacques

RealTime-CTMS strives to build a strong team dedicated to the success of our customers. Our staff goes above and beyond to achieve this each day. We give back to clinical researchers by creating software that is more efficient, reliable, and easy to use, while providing the best customer service. Each month, we are excited to showcase one of our outstanding team members in a Behind the Software feature. This month, we are featuring our eSOURCE Product Manager, Chris Jacques!

Chris Jacques has been with RealTime since 2019. He spent 10+ years in the clinical research industry and is committed to the continued advancement of Realtime’s eSOURCE product. His goal is to provide the most effective and efficient way to collect data for this industry. Let’s go Behind the Software with Chris.

What do you enjoy doing outside of work?

I love being with my kids and wife. We enjoy camping and cruising around the lake or fishing offshore.

Have you learned any new skills during the pandemic?

I’ve learned how to better delegate tasks and responsibilities to team members. I would also say helping team members by pointing them in the right direction while still letting them solve and resolve issues themselves to allow for personal growth and better understanding.

Who would play you in a movie about your life?

I read this out loud, and my wife said, Charlie Hunnam. That is a tough one. I would say Bruce Willis but from the 90’s because Die Hard never gets old, lol.

Do you have any pets?

Yes, I have two dogs that have been adopted. Murphy and Penny.

What is one of your favorite songs?

I have a special play list for my favorite songs. I use this playlist when I need to focus on a project, ride my Harley, or anytime I want to jam and not think of anything else. My favorite song would be Kickstart my Heart by Motley Crue. 

What was your first cassette tape or CD?

This is so hard to remember! I believe it was the TOPGUN soundtrack or Journey on cassette tape.

Are you binge-watching anything?

Yeah, The History of Swear Words on Netflix (when the kids are sleeping haha). 

Favorite travel spot?  

Simple, the Lake or Coast. 

If you could choose your age forever, what age would you choose and why?

If I could stay 28 y/o that would be great. During this age, I still had a great metabolism to go with a big appetite. Now I must watch the calorie intake or make time to exercise.

What’s your biggest fear?

My biggest fear is not living life to the fullest before my time on this earth is done.

What do you like most about working for RealTime?

I absolutely love the company culture at RealTime. RealTime provides excellent customer service, which I believe the RT staff truly embraces. I also enjoy the work-life balance and the understanding of that need from the company.

Thank you for going Behind the Software with Chris! If you are interested in scheduling a demo for eSOURCE or any other RealTime solutions, call (210) 852-4310 or fill out a contact form

28 Jan 2021

eSOURCE Template Build Service with Nathan Levens

RealTime-eSOURCE does the work for you and removes the burden of building source documents. Our system was built and tested by research site professionals, allowing more time to focus on subject recruitment, conducting study visits, and overseeing subject safety. One of the many services that RealTime offers to keep your staff’s focus on what really matters is the eSOURCE document building service.  RealTime will build comprehensive and user-friendly eSOURCE documents for your studies quickly and affordably.  Further, outsourcing eSOURCE building to RealTime will help ensure that your eSOURCE forms conform to industry standards and utilize the full capabilities that RealTime-eSOURCE offers.

RealTime is dedicated to providing the best systems and services to make your job easier, and eSOURCE is no exception. We asked Nathan Levens, Director of Virtual Solutions and Technology at RealTime, to tell us more about how eSOURCE is enhancing site performance and profitability as well as to provide a better understanding of how the eSOURCE template building service works for customers.  Here is what Nathan shared with us: 

Q&A with Nathan

What does your position entail, and how long have you been with RealTime-CTMS?

I’ve been with RealTime for just over 5 years, but I had used the system for 5 years before joining the RealTime team. A total of 10 years using the RealTime systems! With my background in clinical research and quality assurance, I’ve been lucky to help RealTime design products and services that help our customers transition to paperless research processes.  My current position allows me to ensure that our products continue to meet the needs of our customers while also identifying opportunities to help our industry move towards virtual trials using our software platform.

What do you enjoy most about your job?

I enjoy designing and improving software that changes the way clinical research is conducted, but I really get satisfaction from seeing our customers successfully implement the RealTime system.  The system solves so many problems for customers and it’s very rewarding to see happy users.

Tell us more about eSOURCE in general.

RealTime-eSOURCE is a system that allows research sites to replace paper-based source documents with electronic source documents.  This allows for electronic data collection during protocol visits which leads to more efficient site processes, electronic signatures, user notifications, monitor portals, query management, and a lot more. Data can be collected using our MobileAPP and/or desktop version of the system.

Tell us about the eSOURCE Document Build Process. 

Building eSOURCE documents requires serious brain power to dissect the protocol and EDC requirements for each study.  Our customers typically have study coordinators or other high-level employee perform this task.  Our system uses a simple drag-and-drop design tool that allows users to customize the organization of their eSOURCE patient chart and procedure list at each visit. For standard eSOURCE documents, users can create and save templates that can be copied and modified on new studies to cut down on the time it takes to design a study.

Why is the eSOURCE Document Build Service so important?

The typical building process forces study coordinators to build source documents for each of their studies.  While there is some value in having the study coordinator perform this task, it removes the person from other very important tasks like subject recruitment, conducting study visits, and subject follow up.  This service is designed to help study coordinators focus on other critical tasks while we build the eSOURCE documents for them. 

What are the next steps to get started with the eSOURCE Document Build Service?

It’s super easy!  Contact the eSOURCE team at esource@realtime-ctms.com.  One of our product specialists will help you get started.  If you don’t currently use our eSOURCE system and want to learn more, the eSOURCE team can help schedule a live web demonstration.  Live demonstrations are the best way to learn the system’s capabilities and get all your questions answered.

If you would like to see how RealTime-eSOURCE can transform your research business into a cost-efficient, productive and profitable operation, click or call to schedule your free demonstration today!

Thank you, Nathan, for your dedication to RealTime and our customers!

26 Jan 2021

Make the Switch in 2021 to RealTime-CTMS

Say goodbye to 2020 and hello to fresh starts in 2021! RealTime-CTMS wants to help you get your year off to a great start and, perhaps it’s high time to re-evaluate your Clinical Trial Management System (CTMS). There is no better time to start your research than now. Choosing the right CTMS takes careful evaluation requiring a substantial time investment as well as extensive research. It’s imperative to feel confident in your decision to make the switch and  know that your business will successfully make the transition; RealTime-CTMS wants to help!

RealTime-CTMS streamlines the process of migrating from your current CTMS into the industry-leading RealTime-CTMS system.  Further, migrating into RealTime will give your site or site network access to advanced tools such as eDOCS, eSOURCE, TEXT, and PAY.  The foundation of RealTime’s success is built on our customers’ feedback. We are continually growing and evaluating our customers’ needs to advance our products’ capabilities and continue to lead innovation in our complex industry. Learn more about the RealTime-CTMS difference.

SOMS (Bundled Solutions)

RealTime is the first complete Site Operations Management System (SOMS) that allows research sites to bundle together every solution needed to run at peak performance while managing all aspects of site operations. All of our products (CTMS, eSOURCE, eDOCS, SitePAY, and TEXT) work seamlessly together as one system to streamline processes and eliminate paper. You can pick and choose the product bundle that works best for your research site.

eSOURCE

Managing your source data can be a seamless process with RealTime-eSOURCE. You can save time on data collection, management, and monitoring with customized source templates. Custom source templates allow you to reuse and modify form templates for future studies. Managing multi-sites has never been easier!

eDOCS

Our industry-leading eRegulatory system, RealTime-eDOCS, allows sites to easily manage all their study records while maintaining inspection readiness during the entire process. Stay in compliance at all times by facilitating inspections, audits, and study requests. eDOCS is Part-11 and HIPPA Compliant, giving you peace of mind.

SitePAY

Say goodbye to cash or checks when paying patient stipends! One-click will load visit stipends onto a convenient reloadable PAYcard. The funds are immediately available and can be viewed, managed, or transferred to a bank account through the PAYcard portal. It doesn’t get any easier than SitePAY!

Let 2021 be the year of new! Whether you’re ready to make the switch or still weighing your options, RealTime-CTMS is here to answer your questions. Request a demo today; let us show you the RealTime-CTMS difference.

19 Oct 2020

3 Tips for Staying Audit-Ready

Maintaining audit-readiness is the best way to ensure that your site is prepared for audits and inspections, both planned and unplanned. This proactive approach prevents headaches and last-minute scrambling by staff in the event of an actual audit.  The following tips will help you ensure that your team is audit-ready.

Create

Create and establish an audit-readiness plan.  This plan will include several processes, including but not limited to, documentation management, vendor and technology qualification, employee training programs, and an employee feedback program.  Another key component is having a technology access plan; a process for supplying online access to your systems (e.g., RealTime Access Portal). Maintaining an annual internal audit program with a CAPA plan (Corrective Action/Preventive Action) will help detect gaps and opportunities for improvement before an external audit occurs.

Prepare

Perform mock audits to ensure compliance and identify areas for improvement.  As a continuous process, the appropriate staff should ensure all procedures, study-specific or clinic, have been properly followed and any deviations resolved.  This will include all clinic staff’s current curriculum vitae, licenses, and training records are filed in accordance with the clinic’s SOPs. Study-specific records can be reviewed continuously throughout a trial to ensure adequate maintenance of records, whether paper based or electronic.  While this is a short list of activities that can help your team prepare, being prepared at all times will ensure success during planned and unplanned audits.  

For Part 11 compliant technology (e.g., RealTime-eDOCS/eSOURCE), ensure that all current validation documents and compliance letters are available. Most auditors will request software compliance and regulatory documentation for all Part 11 compliant applications, since these systems track, collect, and analyze study data. 

Execute

You and your team should relax and trust that your thorough audit-readiness plan sets you up for success. All of your hard work and preparations will pay off!  If an audit does occur, it’s good to have an SOP for hosting an audit. This SOP will assign a team to quickly coordinate and respond to all requests made by the auditor and ensure that processes are being followed. If the auditor has findings (they typically do), remind the team that everyone is human, and mistakes are expected. Be honest and ask for recommendations on how to fix an identified issue. The auditor will want to make sure that you can adjust and prevent the issue from occurring again. Take the advice as positive criticism!

Conclusion

Being prepared for audits and inspections requires a thorough audit-readiness plan, ongoing preparation and the ability to execute processes when hosting an audit. Showing Auditors your team is a well-oiled machine, will set the tone for all future engagements. Follow these simple steps to be the ‘Sage on the Stage’ and let RealTime be your ‘Guide on the Side’.


RealTime-eSOURCE and RealTime-eDOCS offer exemplary built-in parameters that enforce these compliance standards. Are you ready to make the switch to audit-ready clinical trial software? Get started by scheduling a free demo with a RealTime expert! Call us at 210-852-4310 or fill out the form below!

01 Oct 2020
realtime ctms scrs global site solutions summit 2020

RealTime is Making an Impact at SCRS 2020

This October, RealTime Software Solutions is proud to partake in SCRS Virtual Global Site Solutions Summit! With a full virtual events and workshops schedule, we wanted to share the sessions we are most excited about.

Tuesday, October 6, 2020 | 2:45 – 3:45 EST

Site Business Health: Withstanding Disruption During a Pandemic

Many clinical research sites know their finances and take the necessary steps to prepare for disruptions. In this session, we will hear from business owners what strategies they practiced before and during the pandemic. We will hear from several speakers, including Kay Scroggins, RN, President & CEO, Clinical Trials of Texas, and William Smith, MD, MBA, CEO, Alliance for Multispecialty Research.

Thursday, October 8, 2020  1:30 – 3:45 EST

Breakout Session: Risk-Based, Centralized, Remote Monitoring, Say What? Quality Control, Explained

If centralized and remote site monitoring (RSM) wasn’t yet on your radar, the COVID-19 pandemic brought it to you. But what exactly is RSM and what do they mean for sites? We are eager to hear speakers including Beenu Kapoor, MBA, MS, Vice-President, IQVIA and Summer Iverson, MSHS, CCRA, Process & Standards Lead Global Site and Study Operations, Pfizer discuss more on this crucial topic.

Friday, October 16, 2020 | 12:15 – 1:15 EST

Mater Workshop: The Transition to Paperless Technology in Clinical Trials

As a result of Covid-19, the industry has rapidly adopted paperless systems to allow for electronic source, paperless regulatory site files, remote monitoring, virtual visits and more. This webinar will explore the great benefits these systems have brought to our industry during this challenging time and address the opportunities that have arisen. We will also openly discuss these systems’ long-term impacts for sponsors, CROs, and sites as we move into a completely paperless world. Our very own Rick Greenfield BBA-IS, CEO, RealTime CTMS, and Nathan Levens, Director of Virtual Solutions & Technology, RealTime CTMS, will be presenting the workshop.

RealTime Software Solutions Global Site Solutions 2020 Video

We are excited to be presenting a breakout video during the virtual conference. You can view the entire video here: https://youtu.be/8TFzGv3QpIM.


RealTime is excited and proud to be a sponsor of SCRS Global Site Solutions Summit. To view the full agenda for the summit, click HERE. To learn more about RealTime and our innovative software solutions, visit realtime-ctms.com. Schedule a demo with one of our product specialists by filling out a contact form or call 210-852-4310.

09 Jun 2020

Keeping research compliant amid the COVID-19 crisis

Many clinical research sites and sponsors are accepting new paperless processes in light of the novel COVID-19 crisis. With the inevitable switch to paperless clinical trial systems, one can hope that the same industry guidelines are equally enforced.

With any process, there are rules; the clinical research process is no different with most prescription drugs taking years to hit the market. Each part of the research process involves a multitude of regulatory guidelines that ensure the safety, security, and ethical standards of clinical trial data. Let’s cover the main checkpoints that certify your clinical trial systems’ compliance.

General Data Protection Regulation (GDPR)

The General Data Protection Regulation 2016/679 (GDPR) is an EU law that enforces data protection and privacy in the European Union and the European Economic Area. It addresses the outbound transfer of personal data to other countries. Your clinical trial software should enforce GDPR guidelines if you are conducting trials or transferring data from the EU and EEA areas.

FDA CFR Part-11

Essentially, 21 CFR Part 11 regulations define the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records. This guideline allows companies to replace any paper record or hand-written signature with an electronic record/signature. The truth is every investigator’s site already has electronic records, but most companies are so unsure of Part 11 compliance that they resort to printing paper in fear of being non-compliant with regulations. Ensuring your clinical trial software meets this standard is crucial.

HIPAA Compliant

The Health Insurance Portability and Accountability Act (HIPAA) safeguards electronic protected health information (ePHI). This is important for clinical researchers as it establishes the circumstances in which they can disclose ePHI. Your clinical trial systems should unquestionably safeguard ePHI.

Are your clinical trial systems compliant?

Now that you understand the significance of compliance in your clinical trial systems, it might be time to ask: Are your clinical trial systems compliant?

RealTime-eSOURCE and RealTime-eDOCS offer exemplary built-in parameters that enforce these compliance standards. Each solution exhibits GDPR, FDA Part-11 HIPAA Compliance measures that allows you the freedom to conduct research remotely while having peace of mind.

So, are you ready to start your clinical research compliance journey? Get started by scheduling a free demo with a RealTime expert! Call us at 210-852-4310 or fill out the form below!

31 Mar 2020

Utilizing Remote Monitoring Study Portals Through a Pandemic

During this challenging time, maintaining clinical trial progression is a novel challenge as on-site data and regulatory reviews are either impossible or extremely limited. Travel limitations and “stay home” initiatives across the country have hindered the way clinical trial data is handled. Many clinical research sites and sponsors are left without the data records needed to conduct safe and timely trials.

RealTime’s eSOURCE and eDOCS could be the solutions you are looking for to maintain visibility, data integrity, subject safety, and keep operations moving. RealTime systems provide complete monitoring portals to review eSOURCE data and eRegulatory data. These portals allow sites to upload their source documents and regulatory documents for remote review, provide for query management, document versioning, document download, and more. Here are the key features that RealTime can rapidly deploy:

  • Source Document and Regulatory Monitoring portals – Online access allows Sponsors to collaborate more effectively during trials and streamlines monitoring activities.
  • Query Management – Sponsors can review, track, and issue queries on records from the monitoring portal. Sites communicate directly to the monitor for a quick resolution.
  • Document Version Control – Source documents can be uploaded by sites using our document control feature.
  • eSignatures – Electronic signatures dramatically increase efficiency when gathering staff/doctor signatures. This feature also maximizes subject safety oversight by allowing more timely doctor assessments on lab reports, ECGs, and other critical documents.
  • Part-11 Compliance – Our systems are secure, validated, and ready to go! Complete audit trails and data controls are maintained within the system for users to reconstruct the time of events and prevent human errors during data collection. These features improve accountability and data integrity.
  • Secure Cloud Hosting – All records are stored with a thorough data security/backup plan and encrypted for maximum security.
  • Built-in Reports and Notifications – Quickly review queries across all records, including query statuses.

 

Here at RealTime, it is our goal to help guide you through this moment and get your clinical trials back on track. We are here to help. Give us a call at 210-852-4310 or CONTACT US to learn more!