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Category: CTMS

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.

20 Jul 2020

Why it’s important to choose the right CTMS the first time

Choosing the right Clinical Trial Management System (CTMS) takes careful evaluation requiring a substantial time investment as well as extensive research. When choosing a CTMS, you should feel confident that you are making the right decision, as the wrong decision can be very costly to your organization in the short-term, resulting in long-term consequences.

The Depth of CTMS

When it comes to conducting clinical research, there are so many layers and processes that are required to make a successful research site run. Your entire organization relies on efficient processes and procedures that span multiple departments, tight adherence to regulations, and strict quality controls. Today’s CTMS includes much more than typical study management. Systems now provide researchers and staff with the ability to manage regulatory files, data collection, and communication and financial management tools all electronically.

Switching is a Nightmare

Imagine trying to change CTMS vendors with all your research data spanning all of your critical departments and processes floating in limbo. Considering the amount of complex and confidential information like study documents, patient data, study visits, financial tracking and so much more that essentially make up the backbone of your organization, the decision to change is huge and, quite honestly, most sites simply stick with that they have to avoid the headache of switching. Feeling stuck in a system that doesn’t meet your needs and limits your site’s ability to grow is a bad place to be. But if you have made the tough decision that it is time to make a change, make sure to ask potential vendors about the transition process, their experience with accomplishing these tedious transfers, and the expected outcomes of the data transfer. All the above helps to emphasize one key point… it is very important to choose the right CTMS the first time!

Evaluate and Compare Systems

When shopping for a new CTMS, here are some things you should examine:

  • Look at the longevity of the company
  • Compare real customer reviews and ratings on review websites such as Capterra
  • Compare pricing options
  • Look at the company’s values and mission
  • Look at their customer support options
  • Compare add-on software options that align with your site’s needs such as eSOURCE, eDOCS, automated stipend management, recruitment modules, system integrations, text messaging and more.

There are plenty of clinical trial management systems on the market and they will all have a good pitch, so you must take a close look at the depth and usability of the software. It is also a good idea to talk to references of similar organizations utilizing the products that you are most interested in.  A BIG question to ask is, “how well do they support you and your staff?”

Your Success Depends on it!

Standing out from other sites, consistently succeeding on your studies and providing quality and compliant data to your sponsors is the key to success.  Your CTMS is the information system that will greatly influence your organization’s ability to reach its highest goals, so it’s fairly safe to say that your organization’s success depends on choosing the right CTMS!

We hope that you give RealTime the opportunity to show you the systems that have built a global footprint of highly evolved and sophisticated sites and site networks utilizing proven CTMS that continue to advance year-after-year. We will take you on a full tour of the RealTime-SOMS (Site Operations Management System) with our highly research-knowledgeable team.  We think you will find that no other CTMS compares!

Schedule a FREE demo today by calling (210) 852-4310 or click the button below!

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!

06 May 2020

What does “Your Success” in Research mean to RealTime? A conversation with Scott Butcher, VP of Operations

What makes your clinical research site successful? We all hope to be able to fully answer this question someday, but RealTime Software Solutions is working tirelessly to make meaningful improvements in site operations to help Research sites, Site Networks, Universities, and Hospital systems find their ultimate success.

In a conversation with RealTime’s Vice President of Business Operations, Scott Butcher, MBA, we discuss what their motto of “Your Success is Our Success” means to the RealTime team and how it drives the work that RealTime does each and every day.

Scott, tell us what “Your Success is our Success” means to RealTime?

While delivering amazing customer experiences has always been a priority at RealTime, our strategy evolved further in 2020 as we adopted the theme of “Your Success is Our Success.” Central to this is the idea that on every interaction, whether personal in nature with a member of our team, or through the experiences our customers have while using our research software, we strive every day to deliver outcomes that ultimately drive success and value to our customers. We also know that there is a multiplier effect from our actions. If we can ensure that our customers are successful, the speed at which a new drug or vaccine hits the market can be accelerated and ultimately help us save more lives in the process. Nothing is more motivating to our RealTime family then achieving this goal, especially now, as we provide the necessary tools for our brave customers on the front lines who are working tirelessly to bring forward a cure for COVID-19.

What is a key element of the “Your Success is Our Success” theme?

We feel that a critical component to achieving success for our customers is to always think and operate with the end users experience in mind. To accomplish this, we’ve prioritized our development processes to think like clinical researchers. As a result, we are developing software based on Coordinators, Recruiters, Site Managers, Investigators and other research staff member’s desired experiences. Our customer’s feedback ensures the capabilities incorporated within our research software enhances their daily workflow and provides greater efficiency, visibility, quality, and ultimately leads to increased production and success for all of our RealTime users.

How valuable is customer feedback?

Simply put, customer feedback is central to our Strategic Priorities, Development Roadmap as well as our Customer Service Strategy. We’d like to think that we know what a perfect solution looks like but at the end of the day, we have to bring to market solutions that adapt to the ever-changing needs of the clinical research industry. The valuable interactions we have with Sites, Sponsors, CROs and other industry experts provides greater insight into what is working well, but more importantly, where further innovation is required in order to meet the growing needs of all stakeholders and streamlining a very complex and highly regulated environment. We are extremely proud of the fact that RealTime was built from feedback provided by our customers. Without this valuable feedback, we’d be acting on a hunch rather than the true voice of our customers and the needs of the industry.

How does RealTime capture and utilize feedback from customers?

RealTime takes customer feedback very seriously, and we believe this is one of the many differentiating factors between ourselves and our competitors. Throughout a customer’s journey with RealTime, we continually seek feedback through various methods such as conferences, customer satisfaction surveys, software rating agencies as well as through the daily interactions our customers have with our Customer Success team. Realtime is extremely proud and thankful for our 5-star ratings on Capterra. The testimonials provided by our valuable customers provide constant motivation to our team and reaffirms that our customer-first strategy is truly making a difference. We also appreciate and encourage constructive feedback, because at the end of the day, we know that finding software solutions to our customer’s problems ensures a more efficient clinical research process for all.

Thank you, Scott, for your input and insights into RealTime’s strategies for customer success.  Your success in clinical research is closer than you think. If you have questions about RealTime Software Solutions and would like to take the next step towards successful research, call us today at 210-852-4310.

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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!

27 Jan 2020

The Future of Clinical Trials: Q&A with Rick Greenfield, CEO of RealTime

As we segue into a new year, one can’t help but wonder what the future of the clinical research industry looks like. Cutting-edge clinical trial software, research advancements, and other breakthroughs have proven to shape the clinical research industry that we know today. In a Q&A with Rick Greenfield, CEO of RealTime Software Solutions, we discuss the future of clinical trial software and how RealTime is helping to meet these changes.

Question: How is RealTime adapting to the changing industry?

Rick: RealTime has developed solutions that are adaptable for any organization. Whether you are at the site, site network, hospital, university, sponsor or CRO, RealTime is developing advanced systems to improve processes and efficiencies for the clinical research industry from top-to-bottom. We make it a top priority to listen to the feedback of our customers, who guide our development roadmap and help us meet the growing needs of the industry.

Question: What can we expect from RealTime in 2020?

Rick: Lots of exciting things! I like to keep the competition guessing, so I can’t disclose the long-term goals, but short-term, we will be enhancing all of our products substantially this year.  We also have new systems coming that, I believe, will be industry game-changers.  Current and Future RealTime customers have a lot to look forward to.  So basically… stay tuned!

Question: Where do you see the clinical research industry headed?

Rick: There is a shift happening in the industry as well as a lot of uncertainty as to where things are headed and how we will all be affected by those changes. There is no question that we are moving rapidly towards paperless systems.  I also believe whole-heartedly that site-based systems for site-based functions are essential to a successful operating model.  Sites need standardization and systems that ultimately cater to their needs.  Sponsor-based, or top-down systems, meant to take over a site-based function, are disruptive to good processes, quality, efficiency, and ultimately, data integrity and patient safety.  We have seen the top-down approach fail time-and-time again, but we are seeing huge successes with site-based systems that connect up to Sponsor/CRO systems.  I believe this is the model that everyone collectively must embrace, or they will end up watching it happen before their eyes.  Those that get on board early can be a part of building something truly transformational, which will include the right solutions and maximum benefits for all parties involved.

A little philosophical, I know, but I am convinced of this path to a streamlined industry.  It leads us to the ultimate in virtual/decentralized clinical trials and efficiencies that we have only dreamt of to-date.

The shift has begun! With 2020 upon us, what kind of expectations do you have for your business? If you’re interested in learning more about RealTime Software Solutions, contact us today!

Are you interested in a demo of our products? Give us a call at 210-852-4310 or CLICK HERE to fill out a contact form!