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Category: eDOCS

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!

30 Mar 2020

San Antonio based software company keeping clinical research moving amid COVID-19 crisis

San Antonio, TX – As COVID-19 clinical trials start to ramp up around the country, the research industry has struggled to continue operating. As more and more cities implement orders to shelter in place, the way clinical trials are monitored has faced a challenge.

RealTime Software Solutions, a San Antonio based software company, is giving the industry a facelift that may forever change how research is conducted. Clinical trial monitors have historically visited research sites in person, collecting and monitoring crucial trial data. As most (if not all) sponsors and contract research organizations (CRO) have halted travel, and many sites limiting access to their locations, the need for other options have emerged.

“Sponsors and CRO’s are facing serious challenges in gaining access to study data and regulatory documents for important monitoring activities,” says Rick Greenfield, CEO of RealTime. “A rudimentary, inefficient and non-regulatory compliant solution, is for sites to scan and email these confidential and highly sensitive documents to the monitors for review.”

In steps RealTime.

“RealTime is now implementing emergency measures and spinning up complete portals for sponsors and CRO’s to deliver monitoring systems to their sites,” says Greenfield. “This will allow a quick and easy option for sites to upload data source and regulatory documents for review.  These systems are FDA Part-11 and HIPAA compliant, and provide excellent categorization and version control of uploaded study data for efficient monitoring.”

RealTime portals also include two-way data monitoring communication to maintain a strong connection between the sites and study-management personnel.

“This is such a challenging time for the entire world, and we are all trying to make sense of the massive change that has taken place in our society and the global economy,” says Greenfield.  “Just like everyone else, we are looking for ways to help and we are thankful to have been working for the past several years on systems that can provide a major benefit to the clinical research industry at this most critical time of need.  I urge all Sponsors and CROs to reach out to RealTime as we can deliver a complete monitoring portal to run multiple clinical trials for an unlimited number of sites within 48 hours.  We can train on the usage and have these systems fully operational in less than a week.”

RealTime has been at the forefront of clinical research technology, providing cutting-edge software to an industry that has been somewhat antiquated. This latest technology may change how trials are conducted and monitored, allowing a more streamlined approach.

“If we can keep clinical research moving with absolutely no additional risk to sponsor/CRO staff, then we can keep searching for better treatments and cures when they are most needed,” says Greenfield.

To learn more, visit realtime-ctms.com or call (210) 852-4310.

About RealTime

RealTime is a leader in advanced clinical research software with leading Clinical Trial Management Systems (CTMS), eSOURCE and eDOCS portals for completely paperless clinical trials.  The value of these systems is shining bright during this difficult time and allowing clinical research to continue for the benefit of medical advancements to include COVID-19 vaccine and treatment studies.

Call RealTime today at (210) 852-4310 or email info@realtime-ctms.com to learn more about remote monitoring portal delivery.

28 Feb 2020

5 Reasons Why Your Site Should Be Using Paperless Systems

The year is 2020 – you’re running a clinical research site and realize your workflow is still primarily running off paper systems. Files are overflowing your workspace, paperwork is getting lost between your site staff and doctors, and before you know it, you’re stuck in a paper vortex!

Has this ever happened to you? The reality is that the vast majority of the clinical research industry still mainly works with paper systems. Paper has been the standard for regulatory processes for years; however, many research organizations now realize the benefits of transitioning to paperless clinical research systems. Let’s go over the top 5 reasons why your site should be taking advantage of these paperless systems!

  1. Using paperless clinical research systems lowers the risk of inefficiencies and inaccuracies. These oversights are caused by several reasons including the delay in data receipt and review by the Sponsor or CRO, time and travel expenses of on-site review of source and regulatory documentation, or the higher probability of transcription errors from source to EDC.
  2. Reduce redundant, non-Part 11 compliant, storage systems to store document copies by switching to a Part-11/HIPAA compliant eDOCS Sites can easily manage all their study records electronically while maintaining inspection readiness during the entire process (no clutter involved!).
  3. Decrease enrollment times and increase patient experience. RealTime-CTMS allow sites to input accurate and full medical histories directly into the software before and/or during patient visits. Track study progress, milestones, financials, and more, all within an easy-to-navigate paperless portal!
  4. Increase organization and collaboration amongst site staff by adopting mobile devices. Stay organized with collaborative calendars, instant notifications, and study alerts. Now, you can take your source/study documents anywhere and always stay notified!
  5. Decrease opportunities for poor clinical practices. Paper-based central files such as staff professional documents (Licenses, CVs, Certifications), and equipment calibration records can be kept electronically, allowing staff to update their documents when they are expiring. Audit trails can also make monitoring site staff and study activity more effortless than ever.

Making the switch to paperless clinical research systems will ultimately increase efficiency, accuracy, quality and reduce operational costs. Advancements in technology and newly adopted site-centric approaches are making it possible for these paperless systems to improve the workflow benefitting all parties (Sponsors, Sites, CROs, IRBs, and the FDA).

At RealTime, Your Success is Our Success! If you would like to learn more about going paperless, call (210) 852-4310 or fill out a CONTACT FORM!

14 Feb 2020

How can your CTMS make your site or site network a recruitment powerhouse?

Patient recruitment in clinical trials is undeniably one of the most challenging obstacles facing the clinical research industry. The lack of patient participation in clinical trials can be due to multiple factors but the most likely cause of low or slow enrollment is simply the lack of clinical trial awareness.

Digital technology and connectivity have made it easier for research organizations to connect with potential patients. Adopting the right clinical trial management system (CTMS) into your site operations can also help to improve patient recruitment, retention, and turn your site into a study recruitment powerhouse. Let’s delve into the top reasons your site may want to consider RealTime-CTMS.

Advertising Mastermind

Let’s face it; we’re not all blessed with the capability (or time) to manage study campaigns, track ad spend, and remarket to study applicants. However, with RealTime-CTMS, your site holds the power to do all the above!

Your site can track ad spend budgets and patient referrals within the RealTime’s Recruitment Campaign Manager, a section in CTMS designed with your advertising needs in mind. In addition, RealTime offers robust integrations with Facebook, Instagram, MailChimp, Twilio, SubjectWell, and more that can help advance your study marketing efforts.

Leads, Leads, Leads!

Following up with new leads is crucial for a successful study. Whether your site is utilizing traditional or digital advertising, RealTime’s clinical trial management system auto-codes where your referrals are coming from, helps manage lead follow-up and lets you easily remarket to qualified patients. Clinical trial patient recruitment and engagement has never been easier!

“Can you text me?”

Why, yes. Yes, we can. RealTime-TEXT will take your patient recruitment to the next level with the only FCC-compliant Mass TEXT tool that will allow you to TEXT thousands of patients with one click. Boost recruitment by instantly notifying your patient database of new studies at your site, auto-notify patients with automated appointment reminders, and set up email alerts to inform site staff of new TEXT messages from patients.

Recruitment Powerhouse

Advertise smarter, track study budgets, and stay connected with your patients to let them know about new enrolling studies, while participating and after they have completed a study. With RealTime-CTMS, your site can become a clinical research recruitment powerhouse!

To learn more about RealTime-CTMS and its many robust features, schedule a free demo with one of our experts! Call 210-852-4310 or fill out a CONTACT FORM!

25 Nov 2019

Ask the Experts: Getting sponsors to cover your site-based electronic solutions

Site-based clinical trial software systems such as RealTime-eDOCS and eSOURCE are becoming more commonplace and essential than ever before.  These solutions are part of a fast-growing market of site-based systems in the research industry that is reshaping research processes. One common topic of concern of the sites is the cost of these systems and the potential to have those costs covered within their clinical trial agreements and study budgets with the sponsors. The efficiencies that these systems bring to sites substantially, if not entirely, offset the costs. In addition, there are benefits for sponsors and CROs, which include remote monitoring, real-time access to study data and documents, complete oversight of Investigator and staff performance, and more.

This article will provide some justifications and best practices that sites can leverage to request and receive compensation from sponsors, which will, at the very least, help to cover some of the costs associated with these advanced systems.  

In the course of working with hundreds of sites that are currently leveraging these robust systems, the RealTime team has observed practices used by sites in approaching sponsors to help cover the cost of their site-based electronic systems. Here is what we found:

  1. Sites that are confident in their electronic systems and processes tend to be better negotiators. They understand the value that the system brings to, not only to their operations but the sponsors and CROs as well.  The shift to these systems is no longer a question of “if” the industry will adopt site-based electronic paperless systems, but “when” the transition will be realized in full.
  2. One way to quickly consider the offset of eRegulatory systems is to consider the fact that the typical Archival Fees that sites receive to archive and store records will no longer be needed to cover the cost of storage. For systems like RealTime-eDOCS, there are no annual storage fees.  Further, the archival process can be substantially reduced to a simple review and validation that all documents are present in the regulatory system for long-term holding.
  3. For eSOURCE, sites are encouraged to increase the per-visit revenue by at least $10 per visit. By doing so, this will cover the cost of CTMS and eSOURCE for that study, in full. Many sites add a line into their study budgets for QC/Data Entry with a rate of at least $10 per visit to cover the cost of data review for accuracy and data entry into eSOURCE and EDC.  Some sites are consistently successful in receiving a rate of $25 or more for this fee.
  4. Some sites add the cost of their electronic systems to their General Overhead Fee. A 1 or 2% increase in overhead across all studies will easily pay for your eSOURCE system.

In one case, a site that grouped everything into a “Systems Fee” was able to get the costs of their electronic systems completely covered by the sponsor.

One thing to remember, having consistent processes is paramount to quality and efficiency so it only makes sense to go “all in” with your paperless systems.  Even if the sponsor only covers partial or none of the costs on a particular study, the efficiencies that these systems bring to the site as a whole are still worth it. Utilizing site-based paperless systems has shown to increase productivity, efficiency, and collaboration on every level.

In other words, the improvements in efficiencies and increased revenue opportunities make paperless systems worth the cost. You will be able to do more for less, so the cost is well worth the benefits.  But, there is no question that sponsors and CROs should share in the cost as they too benefit greatly from these systems.  Real-time data, remote monitoring, complete transparency of investigator oversite and site performance, are all enormous benefits that are worth far more than the budgetary increases that sponsors may see from sites.

If your site is interested in learning more about RealTime and our software solutions, give us a call at (210) 852-4319 or fill out a CONTACT FORM.

27 Aug 2019

Segal Trials Announces eRegulatory Milestone with RealTime-eDOCS

This June, Segal Trials announced their eRegulatory milestone with RealTime-eDOCS.

“Congratulations to our Regulatory Department for going paperless! Electronic documents are safe, secure, and allow for quick and efficient handling of more complex studies- along with reducing our carbon footprint.”  – Segal Trials, LinkedIn

Sites like those associated with Segal Trials experience numerous benefits when making the switch to an eRegulatory system.  Benefits include:  Streamlined consistent processes across all studies that save time, reduce space and lower the overall cost of eRegulatory operations.  RealTime-eDOCS includes features such as fingerprint and face-ID, allowing investigators and staff to electronically sign eRegulatory documents from anywhere.  Monitoring portals, ICF tracking, staff documents and training tracking, centralized filing are just a few primary features that RealTime-eDOCS provides to accelerate the eRegulatory processes at a site.

We congratulate Segal Trials on making the switch to RealTime-eDOCS and love to see our customers experience the true benefits that eDOCS can deliver.

Is your site considering an eRegulatory system? Schedule a free RealTime-eDOCS demo today to see ALL that eDOCS can do!

Fill out this contact form or give us a call at (210) 852-4310.

19 Apr 2019

ACRP 2019 – Key Takeaways (and Bandanas)

Each year, RealTime attends a variety of conferences around the globe in hopes of aiding clinical research professionals, sites, sponsors and CROs on their paperless journey. RealTime attended ACRP in Nashville, Tennessee this April and the team had the opportunity to network with professionals in the industry while gaining insight into the realm of clinical research technology. Did you get your RealTime-Bandana?!

RealTime’s CEO, Rick Greenfield discussed one of the hottest topics at the conference:

The Paperless Site –eSOURCE and eREG

In a follow-up conversation with Rick Greenfield, we asked him a few questions on his takeaways from the conference.

RealTime CEO discusses the shift to paperless sites and the challenges sites face when transitioning to paperless systems like eSOURCE and eDOCS.

How do you feel that RealTime is contributing to the shift to Paperless Sites?

“The RealTime-SOMS (Site Operations Management System) is the first of its kind, combining our leading CTMS, eSOURCE, eDOCS, SitePAY, and TEXT into one system. The RealTime-SOMS can also be accessed through the RealTime-MobileAPP, which can essentially eliminate the need for paper and allow site staff and investigators to perform most tasks with a smartphone or tablet.  While developing these paperless solutions has been challenging, seeing the success that RealTime sites are having with the shift to eSOURCE and eDOCS is incredibly rewarding.  I only wish that I would have had these tools when I was running my own clinical research site.”

What was your favorite part of ACRP?

“ACRP was an incredible experience for RealTime.  The best part was seeing how RealTime and the many other vendors at ACRP that are working to change the industry by helping Sites, Sponsors and CROS achieve greater efficiency and better outcomes. It is a privilege to network with other industry professionals and to participate in the search for innovative solutions to the obstacles our industry faces every day.”

Do you feel that Site-Based Paperless Systems will change our industry for the better?

“They already are! The shift to site-based paperless systems is already happening at an astounding rate, and the benefits of these new systems are already being realized by all parties involved in the conduct of clinical trials.  As the shift continues, the clinical research industry as we know it will be faster and more efficient than ever.”

If you missed RealTime at ACRP, here is a list of our upcoming conferences:

  • MAGI EAST | May 5 – 8th | Boston, Massachusetts
  • DIA | June 23 – 27th | San Diego, California
  • SCRS | October 11 – 13th | Hollywood, Florida

Learn more about the RealTime solutions including eSOURCE, eDOCS, CTMS, TEXT, SitePAY and GlobalPAY that are leading our industry into the future.

Click HERE or call (210) 852-4310 to see RealTime products up close!

01 Apr 2019

Behind the Software with Alyssa Arce

One of the things we strive for at RealTime is building a team of people who are passionate about the industry and dedicated to providing exceptional customer support. 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 one of our incredible team members, Alyssa Arce.

Alyssa joined the RealTime team in 2018 and continues to give back to customers by teaching them how to utilize e-regulatory systems at their sites. She is currently the Product Manager for eDOCS program at RealTime Software Solutions.

To get to know her better, we’ve asked her some fun questions!

1. What is a hidden talent you have?

I make great tamales.

 2. What’s the best piece of professional advice you’ve ever received?

Grind.

3. What books/podcasts are you into at the moment?

I’m bigger TV/ movie watcher – Spiderman into the Spiderverse.

4. What’s the coolest or most interesting thing you’re working on right now?

Growing a human.

5. What’s the funniest thing that has happened to you recently?

Probably walking into a room I thought was a meeting but instead it was an in-progress interview.

6. What are the values that drive you?

Kindness, personal growth and communication.

7. What do you work toward in your free time?

Relaxation and self-care.

8. What is the most inspiring part of your job?

Being able to help and teach people our product and how it can change their day to day work lives.

Stay tuned for behind the software as we get to know some of the team behind RealTime Software Solutions. If you are interested in scheduling a demo for eDOCS or any of our other solutions, call (210) 852-4310 or fill out a CONTACT FORM.

05 Nov 2018

5 Ways that CTMS Can Add Value to Organizations

Clinical Trial Management Systems offer essential functionality for tracking study visits, building a robust patient database, managing all study-related financials, and accelerating recruitment.

Over the last decade, the clinical research industry has seen an increase in the use of software systems to perform essential functions, increase efficiency, and reduce costs. Site-based CTMS systems play a large role in the move to advanced systems and processes that are re-shaping how research gets done.

How can CTMS add value to organizations?

  1. Recruitment Tools

Utilizing the vast number of recruitment tools within RealTime-CTMS enables sites to consistently meet enrollment goals and become a top-enrolling site. RealTime’s powerful features allow advertisement campaign integration with traditional media, Facebook, SubjectWell, website landing pages, and personalized mass study alerts.

  1. Build Your Database

With these advanced integration features, new study leads will flow into your CTMS database while simultaneously notifying staff. Staff can manage lead follow-up activity with attention to detail. With a robust database, sites can run detailed criteria searches to identify potential subjects for new studies. Be the first to screen and enroll qualified subjects.

  1. Improve Site Efficiency

From scheduling subjects, managing study documents, leading recruitment, and tracking study visits, to ensuring accurate accounting and timely sponsor payments; RealTime-CTMS will streamline the workflow of your site while ensuring critical site processes are maintained.

  1. Software Integration

Powerful integrations with other systems bring even more value to RealTime-CTMS.  For business development, RealTime can seamlessly connect to Devana Ignite for Sites.  For recruitment, integration can connect with Facebook, Instagram, SubjectWell, websites, Twilio and more. This will give you advanced recruitment tools that no other CTMS can offer.  Integrations with EMR/EHR systems can also streamline the flow of data between your hospital/medical practice and research activities in RealTime.  Embracing and cultivating new integration opportunities is just another way that RealTime is leading the CTMS market.

  1. Track Financials

Track study costs, reimbursements, and all other financials related to study activities with RealTime-CTMS. Subject stipends can also be easily loaded onto reloadable Visa/Mastercards with RealTime’s SitePAY solution.

Take your organization to the next level and add value to the clinical trial process from start to finish. Introducing CTMS, but more specifically, RealTime-CTMS can transcend organizational boundaries, improve efficiency, and act as a seamless portal for all site operations.

RealTime-CTMS can function on a single site, multi-site, or enterprise level. With add-on features such as eDOCS, eSOURCE, TEXT, and SitePAY, RealTime can deliver the one-and-only Site Operations Management System (SOMS) for an end-to-end solution.

To learn more about adding value to your organization with RealTime Software Solutions, call 210-852-4310, or visit www.realtime-ctms.com

24 Oct 2018

Key Takeaways from SCRS 2018

Assembling for a cause

Global Site Solutions has provided a centralized hub where sites, sponsors, and CROs can gather and network. For the past 12 years, Global Site Solutions Summit has given participants the opportunity to promote and build their business, share best business practices, attend insightful workshops and seminars, and develop new partnerships and relationships along the way.

Powerful words

In an eye-opening discussion with Shielia Nagley, she describes her husband’s constant battle with Alzheimer’s Disease and how they discovered the benefits of clinical research.

“Participating in research is the only way we can advance medicine.” -Shielia Nagley, advocate for husband and Alzheimer’s patient, Bill Nagley.

“You give us hope,” Nagley concluded, speaking to researchers, site directors, and those in between.

In a follow-up conversation with Rick Greenfield, we asked him a few questions on his takeaways from the conference.

RealTime-CTMS CEO, Rick Greenfield, speaks at Global Site Solutions Summit 2018 in Boca Raton, FL

How do you feel that RealTime is contributing to the advancement of medicine for patients like Bill Nagley?

“I feel that RealTime is a playing an increasingly important role by bringing advanced efficiencies for Sites, Sponsors and CROs with innovative software technologies such as eSOURCE, eRegulatory, CTMS, patient travel portals and so much more.  By improving the research process and increasing the flow of data and processes between all parties, we can find effective treatments and cures faster than ever before.”

What was your favorite part of the SCRS experience?

“Learning from and networking with all of the amazing professionals in our industry and  Seeing their excitement as my team would showcase the features and capabilities of our software solution.  We always receive great ideas for advancements that we take home to incorporate into future systems.”

Where do you see the clinical research in the next 5 years?

”Systems will connect with each other like never before and data will flow faster than ever. Advanced systems will not only create powerful integrations and increased efficiency but will greatly reduce errors and improve compliance. RealTime is very excited to be on the forefront of this change and to lead the charge to a powerful paperless future for our industry.”

Shannon, Ted, Elise, Nathan, and Rick from RealTime Software Solutions attended SCRS 2018.

If you missed RealTime at SCRS, our team is also attending MAGI West this October 21-24, 2018 in San Diego, California. Learn more about solutions including eSOURCE eDOCS, CTMS, TEXT,PAY and GlobalPAY that are leading our industry into the future.

Learn more about RealTime solutions HERE or call 210-852-4310 to speak to a RealTime expert!