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Tag: clinical trials

24 Mar 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

15 Mar 2021

The RealTime Customer Service Difference with Norma Zayas

Customers are the heart of RealTime-CTMS, and each day our team strives to provide outstanding customer support to all of our clients. Joining RealTime in 2018, Norma Zayas leads the charge as our Success Team Manager, bringing a solid background in account management and client relations. Norma manages our team of dedicated support specialists ready to serve you, our customer.

Please keep reading to learn more about Norma and our one-of-a-kind customer service.

  • Tell us about your role and your time with RealTime.

I have been with RealTime for a little over two years. My role as the Success Team Manager is to support, direct, and lead a cross-functional team dedicated to Customer Success. I am developing customer relationships that promote retention and loyalty. I work closely with customers to ensure they are satisfied with our services and improve upon opportunities.

  • What do you enjoy most about your job?

Many things come to mind; I would say interacting with the customers, leading a team that is ready to assist customers, and opening new ideas to improve our overall customer experience—finally creating policies and procedures that optimize the customer experience.

  • What’s a typical day for you as the Success Team Manager?

My day starts with addressing emails for multiple clients regarding onboarding, implementation, feedback, and attending meetings, assisting with questions and training.

  • How do you ensure customers receive top customer service? 

We are putting them in the center of everything we do!

  • How does RealTime go above and beyond for customers?

RealTime continues to innovate to improve the customer’s experience and tailoring the system to make our customer’s job easier.

  • How do new customers get started with RealTime?

It is very simple! Just reach out to our Sales Team, and they will schedule a demo to get them started. There is no other CTMS like ours in the market today! Thank you, Norma, for your dedication to our RealTime customers. If you are interested in scheduling a demo for CTMS, eDOCS, eSOURCE, GlobalPAY, SitePAY, TEXT, or any of our other solutions, call (210) 852-4310 or fill out a Contact Form.

04 Jan 2021

A Message from the CEO : 2020 Year in Review

2020 has undoubtedly been a year that will be permanently etched in the history books and reflected upon for many years to come. Yet, in these challenging times, the world has quickly learned to adapt and innovate, and together, we are making great strides to defeat Covid-19.

At RealTime, we remain true to our goal of ensuring that our customers are successful, no matter what, which will ultimately ensure that RealTime is successful and we can provide for our families.  With clinical trials coming to a screeching halt in March of 2020, we were all forced to pivot and adapt to this unprecedented and ever-changing environment. I could not be prouder of our RealTime-CTMS team and our entire industry for rising to this great challenge and persevering through it together.

Throughout the rollercoaster of 2020, RealTime was able to help support the industry’s needed and rapid shift to paperless, contact-less clinical trials with our software solutions, eSOURCE, and eDOCS in conjunction with many other tools within our SOMS (Site Operations Management System).  Additionally, RealTime continued on its mission to innovate, with some exciting milestones being accomplished in 2020.

2020 Milestones

  • The launch of DecenTRIAL to allow Sponsors and CROs the ability to leverage powerful site-centric eSOURCE on multi-site clinical trials and eliminating the need for transcription into EDC.
  • Numerous advancements in both eSOURCE and eDOCS aimed to further enhance the data collection process and assist with more efficient remote monitoring by Sponsor/CRO personnel.
  • The release of our intelligent eDelegation Log within eDOCS.
  • The addition of numerous new countries that are utilizing RealTime products.  RealTime is now operating in over 30 countries around the globe!
  • …and so many more!

My hat is off to the group of outstanding individuals that come together to deliver world-class products and unparalleled support to our customers each day.  But none of this would be possible without our customers, who have put their faith and confidence in us.

Looking ahead to 2021

As we move into 2021, we look forward to continuing to fight and defeat Covid-19. RealTime-CTMS will continue to play an instrumental role in finding solutions along with the rest of our industry partners.

Let’s make 2021 a year to remember as we move past the hurdles thrown at us in 2020 and accelerate our shift to a world less reliant on paper, outdated technology, and archaic processes. We will be with you in the trenches!

Sincerely,

Rick Greenfield, CEO

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!

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.

20 Jan 2020

Advanced Clinical Research Systems: The Top-Down Approach

The clinical research process, especially as it relates to data, primarily functions off paper source documentation and manually transcribed data into EDC systems. Most clinical research sites are still utilizing paper regulatory processes. Due to these primarily paper-based systems, there are numerous inefficiencies and detriments to the speed and accuracy of the clinical research process. So why are many sites still using paper-based research systems?

The Problem

As it relates to advanced research systems, FDA regulations have paved the way for electronic document storage, eSignatures, and electronic data capture. However, there is still an evident uncertainty in the industry about the FDA’s acceptance of a paperless process. The slow adoption of these advanced systems, unfortunately, is holding back the clinical research industry from a much more efficient and cost-effective future.

The Top-Down Approach

The Top-Down (or sponsor-driven) approach to adopting advance research systems has proven to be a long-winded process. Adherence to site policies and procedures for data accuracy, GCPs, regulatory compliance, and protocol compliance makes transitioning to paperless systems a significant hurdle. Current top-down systems do not have the user’s (site staff and doctors) needs in mind regarding workflow and ease of use.

The Solution

The shift to advanced research systems such as eDOCS and eSOURCE is inevitable. Additionally, EDC vendors need to help pave the way by offering intuitive data sync capabilities that will bring value to all parties and keep EDC companies relevant in this inevitable shift. As sites adopt site-based eSOURCE and eDOCS systems, the need to efficiently transfer files and data into sponsor-managed eTMF systems and EDC systems will become imperative. The pendulum has shifted!  Advanced electronic systems are proving their value across all organizations!

So, what are you waiting for?

Take the next step to adopting advances research software solutions! RealTime Software Solutions 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 going paperless, fill out a CONTACT FORM, or call 210-852-4310 to speak to an expert today!

19 Dec 2019

Artificial Intelligence in Clinical Research

Emerging software and artificial intelligence in clinical trials are transforming the way research is being conducted. These digital advancements can help to improve, accelerate, and simplify the clinical trial process that we know today. How can your site take advantage of these artificial intelligence capabilities and power your site’s research efforts? Let’s dive deeper into the future of clinical trials.

Subject Referral Coding

When it comes to tracking study recruitment efforts, analyzing and understanding results can be challenging. Automatic referral coding powered by AI can simplify recruitment efforts. With RealTime-AI, subject referrals are automatically coded to specific campaigns. For example, a person sees your study on Google; they click on the ad and apply to the study. That subject has automatically been coded as a Google Ad referral and dropped right into your CTMS study roster. There’s no need to ponder where your leads are coming from!

artificial-intelligence-clinical-trials-ctms

Automated Follow-up and Scheduling

Following up with fresh leads can be crucial for a successful study. RealTime-AI makes it easier for the site to follow up with new leads. AI notifications are sent to new leads via email and text, ensuring prompt follow-up and the opportunity for a phone screening. Text reminders and re-scheduling are sent to subjects automatically, reducing no-show rates!

Financial and Milestone Tracking

As any site administrator knows, study financial tracking is a time-consuming process. Manually entering study financials is now a thing of the past with Artificial Intelligence. RealTime-AI automates screen-fail max and ratio identification with intuitive revenue and cost adjustment based on contract terms. When a milestone is completed, an auto-notification is sent out to the entire site staff.

RealTime-AI has capabilities that can function on a single site, multi-site, or enterprise level. Add on features such as eDOCS, eSOURCE, TEXT, and SitePAY, can power your site and make the clinical trial process easier than before!

Learn more about our RealTime-AI by scheduling a demo with one of our experts. Call 210-852-4310 or visit https://www.realtime-ctms.com/contact/ for more information!

09 Dec 2019
clinical trial management system software customer support

Behind the Software with Shannon Samuel

Building a strong team is crucial to the success of our customers. At RealTime, we have dedicated our time to finding strong individuals to help shape the clinical trial software of tomorrow. Our goal is to give back to clinical researchers by creating software that is more efficient, reliable, and easy to use, while providing the best customer service. This month, we got to know an individual who has dedicated her time to helping customers understand RealTime software and the multiple benefits it can bring to sites.

Meet Shannon Samuel, Sales Director! Shannon has been with the RealTime team since the very beginning. Prior to RealTime, she gained industry knowledge by working in business operations for one of the largest multi-specialty sites in the nation. Today, Shannon brings her experience to RealTime-CTMS solutions in a way that assists sites to understand innovative clinical research solutions. Now, let’s get to know her a bit more!

What’s the top destination on your must-visit list?
Because Australia is home to some of the most unique animals of the world, I would like check it out in person.

What’s one song you have completely memorized?
There are several, but there is one that when it gets played at a party, I will lip sync the whole song. It’s Baby Got Back by Sir Mix-A-Lot.

What’s the coolest or most interesting thing you’re working on right now?
I recently conducted an onsite training with a colleague, and it was great to physically be with the site staff (aka family). I enjoyed not only helping them learn the system but being able to help establish new site processes with the new system was exciting, their excitement fed my excitement.

If you could choose a superpower, what would it be?
To fly

Do you have a hidden talent? What is it?
As I get older, my hidden talents have faded. However, if you ask my husband, it’s the ability to fall asleep on command or when he starts a movie. I just think that’s called “Mom life”.

What’s your favorite famous or inspirational quote?
“A woman is like a tea bag, you can’t tell how strong she is until you put her in hot water” Eleanor Roosevelt

What energizes you at work?
I get energized at work when something that I have done helps improve another colleague or client’s day in some significant way. It encourages me to do more.

What TV shows/movies are you into at the moment?
I recently saw Instant Family and it spoke to my heart. It was like it was written about our family. On evenings when I want to relax, I put on Frasier. It always gives me a good laugh!

What would we most likely find you doing on the weekend?
Saturdays I start off the day with a run at the beach, then errands with some fun shopping. Sundays are typically used almost all day for serving in church.

What is the most inspiring part of your job?
Because I KNOW that our system is necessary for site operations and is literally a life-changer, it is super rewarding when a client has arrived to the same conclusion after implementing our solutions.

If you are interested in scheduling a demo for CTMS or any of our other solutions, call (210) 852-4310 or fill out a CONTACT FORM.

13 Jul 2018
RealTime-PAY: Best Practices Guide

RealTime-PAY: Best Practices Guide

You’ve adopted RealTime-PAY because your subjects and their experience are your main priority. Our system has helped your site reimburse patients for their time and travel with innovative technologies such as direct deposit and an online portal.

Consequently, YOU are our main priority. Our team of experts works night and day to provide you with the best tools to help you run your studies smoothly. That’s why we’ve compiled a guide of best practices your site can use when introducing the PAY portal and system to your patients. This will ensure your patients get all the information they need to get started with PAY while keeping their personal information secure.

MORE: Prioritize your subject’s experience

Do’s and Don’ts when setting up RealTime-PAY

DON’Ts

  1. Don’t – Write down or document any information such as PIN NUMBERS, PASSWORD, and SECURITY QUESTIONS. We understand that having this information might help you assist your patient, especially if they are not familiarized with the online portal or have trouble remembering their security information.
    However, if there is any type of fraud on the account, your site might be liable. Information such as the ones stated above should only be known by the account holder.
  2. Don’t – As a coordinator, you may want to assist your patient by calling Cardholder Services on their behalf but since they may be dealing with sensitive information such as PIN NUMBERS, PASSWORD, and SECURITY QUESTIONS, we recommend for you to refer them to the online portal or to a cardholder service representative.If your patient has questions about the usage of the card, card balance, PIN number, report a lost or stolen card or need general support, referred them to Cardholder Services.

    North America: +1 (877) 546-8220
    Worldwide: +1 (604) 638-6657
  3. Don’t – As mentioned before, the Cardholder Services call center is here to assist cardholders with inquiries about their account. If you have any questions about the portal or how RealTime-PAY can help your site, please call RealTime-PAY customer support at (210) 852-4310.

DO’s

  1. Do – When setting up a new card for a patient:
  • Always verify the spelling of the patient’s name, DOB, address, email, and phone number before assigning a RT-PAY card. All this information is pushed to the card during account creation.
  • Always assign the cards in RealTime before you hand over the card to the patient. This is important to ensure the correct cards are given to the assigned patient.
  • No special characters are allowed in the name field when assigning a card, for example, “Niki” or (Niki).
  • If you receive an error message when assigning a card, check the DOB first. Cards cannot be assigned to anyone under the age of 14.
  1. Do – Take the time to educate your patient about the capabilities of the PAY system and provide them with the resources to ask for help in case it is needed.
    The easiest way to make changes to the account is through the online portal but if further assistance is needed, refer them to Cardholder Services.
  2. Do – When explaining how to set up a PIN number, print out a list of steps for the patient so they can take notes while you go through the process with them. If necessary, sit with the patient through the whole set-up process but clarify that all the information needed is to be for their knowledge only.
  3. Do – Share the following tips with your patients:
  • Memorize your PIN; don’t carry it in a wallet or write it on the card.
  • Enter your PIN so others cannot see it. Do not share your PIN with anyone.
  • If the terminal appears to be modified or suspicious, do not enter your PIN.
  • Notify the Issuer immediately if a PIN change took place without your request.
  • When purchasing gasoline, pay for gas inside the station.
    Gas stations may place a hold up to $125.00 on your card balance when paying at the pump,
    regardless of the amount you pump. This hold may take up to 7 days to release to your balance.
  • When making purchases at restaurants hotels, gas stations, car rental agencies, cruise lines, mail order, and telecommunication companies, keep in mind that they may increase the purchase authorization request or place a “hold” on your card’s available balance to accommodate for potential card overdrafts.
  • Notify the Issuer immediately if a PIN change took place without your request.

Following the previous best practices will help you keep your subjects happy and their information safe.

Key Takeaways:

  • Never write down any sensitive information such as PIN NUMBERS, PASSWORD, and SECURITY QUESTIONS.
  • Take your time going over the PIN setup steps with your patient and if necessary, print a list of steps for them to follow when explaining the process.
  • Review all the TIPS on using the card with your patient.
  • Referred them to Cardholder services if they have any questions or issues with the usage of the card, card balance, PIN number, report a lost or stolen card or need general support.

If you have any questions about RealTime-PAY call one of our experts at (210) 852-4310.

To download the infographics click the link under the image and click “save” or send us an email to rtpay@realtime-ctms.com.

RealTime-PAY: Best Practices Blog                                     

PIN Number Tips                                                          Security Measures                                          DOs and DON’Ts for sites only

13 Jun 2018
What does STOP mean for your site?

Texting STOP doesn’t mean to cease contact with your patients

STOP. It is such a forceful word. We hear it and we immediately tend to stop whatever it is we are doing and go the opposite direction.

As a RealTime-TEXT customer you’ve probably had many potential patients respond STOP to a text message, but what does that mean? Spoiler alert: it does not mean the patient doesn’t want to be contacted at all or ever. To give you some insight, here is how the auto-text is setup and why STOP doesn’t mean to cease all communication with a potential patient.

Here is an example of RealTime’s automated text that is sent to all applications when the SMS checkbox is checked and an indication is set up for each study:

Thank you for your interest in the [insert indication] study at [site name]. Please reply with the best time to call or call us [site phone]. Text STOP to opt out.

STOP in this instance simply means, STOP TEXTING ME. Some people, me included, don’t always like to get salesy text messages and although unlimited texting is a common ground for some of us, others have to pay for text messages received and therefore, opt out of texts.

The STOP reply in this instance doesn’t mean that the patient isn’t interested in receiving a call, email, IM or other form of communication regarding study participation. It simply means that they don’t wish to be contacted via text message.

If a patient opts out of your marketing efforts, you should never opt them back in manually. (This is against FCC guidelines) In order for them to re-subscribe to text message marketing, they will have to text RESUME to the same short code.

*Note: When a patient has opted out from text message marketing, they will automatically receive a follow-up text with instructions to re-subscribe.

Ex: You have opted out and will no longer receive messages from this service. Reply RESUME to subscribe. *

To further understand the anatomy of an automatic reply, here is a breakdown of the main four components:

Anatomy of an automated text message

  1. TEXT Subject: Texts like any other form of communication have to address a specific topic and answer the question: “Why am I being contacted?”
    In the sample above, a potential patient has reached out to your site through your website application form or even a social media ad and will receive an automatic text message. The introduction of this text message has to be relevant to your subject in order for them to respond appropriately.
  2. Sender: This portion of your text message has to answer the question: “Who is sending this to me?”
    A potential patient might be more likely to respond and engage with a text message if they know the sender. As previously stated, this potential patient has actively engaged with your site via website or social media. Therefore, they should be able to recognize the sender.
  3. Contact information: Your text message has to give a potential patient the tools to reach out to the site.By providing your phone number you will accomplish three things:1. Give patients another way to reach out to you with questions about your studies.
    2. Build rapport with them by providing a piece of information about your site.
    3. They are more likely to answer your phone call because they will recognize the phone number.
  4. Opt-out option: All marketing outreach is regulated by the Federal Communications Commission (FCC) and they require ALL marketing texts to include an option for recipients to opt-out of marketing at any time.

 

Texts are an effective way to communicate with your patients and reduce your no-show percentage and improve patient retention rates. If you have any questions about RealTime-TEXT call (210) 852-4310 or text PAPERLESS to 74-121 an experience how RealTime-TEXT works!