Tag: CTMS

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!

06 Jul 2020

FAQ: Compliance in Paperless Research Systems

Why does compliance matter when using an electronic system?

Many established electronic systems provide research organizations a means to hold and secure valuable clinical research documents and data in a paperless environment that allow for greater site and sponsor efficiencies. These systems may include capabilities that span from recruitment tools, enrollment tracking, calendaring and appointment scheduling, data collection and regulatory document management. There are many things that you need to consider when transitioning to electronic systems, but perhaps one of the most important questions to ask is, are your electronic systems compliant with FDA 21CFR Part 11 guidance as well as your local, state and federal data privacy laws surrounding Protected Health Information (PHI)?

Compliance is vital to your organization, especially during a time when our industry is rapidly adapting to electronic systems. Maintaining a state of audit readiness is important, but it is very challenging to know all of the rules and regulations that must be followed and what technical requirements these systems must include in order to keep you compliant. The need for remote monitoring of data that is no longer held on paper is the new norm, but electronic systems must, at a minimum, be able to ensure that data is Attributable, Legible, Contemporaneous, Original, and Accurate, otherwise known as ALCOA. Systems that ensure ALCOA as well as the complex back-end standards that ensure compliance and security regulations, provide assurances of FDA and sponsor acceptance of data and documents held and managed within these systems.

For electronic systems to work effectively, allow staff to efficiently operate in a way that conforms to your established SOPs, ensure data privacy and security, and meet industry Good Clinical Practices (GCPs), certain capabilities should be standard, including:

  • Audit trails detailing the date, time and details associated with each user’s additions, edits or removals of data and/or documents
  • Encryption of data while stored on local or remote drives (at rest) and within the user application (in motion)
  • The ability to generate certified copies of records while maintaining the integrity of the original record
  • The ability to provide record retention while preserving the digital format over a long time (at least 15 years in most cases)
  • Customizable forms and filing templates
  • Integrations with data warehouses such as CTMS to reduce redundant data entry and streamlined linking to financial tracking systems

The Shift to eREGULATORY and eSOURCE Systems:

When using compliant eREGULATORY and eSOURCE systems, your site staff, the Sponsor/CRO, the FDA, IRBs and any other third-party auditors must have quick access to documents, data, audit trails, document versioning and expiration dates, eSignature status reports, source data and so much more. Due to technological advances, general correspondence and essential documents provided through the mail or other courier service are becoming a thing of the past as online portals are the new model for document and data sharing.

While industry processes are shifting almost entirely to online electronic systems, the flexibility and ease for both the Sponsor and Research Organizations are rapidly increasing. This transition to electronic systems allows clinical trials to run more seamlessly with an organized presentation of data, ease of access, proper utilization of time, increased compliance of security, privacy, and GCP standards, not to mention less travel for monitors reviewing data.

When it comes to compliance, what are some essential features to look for in a paperless system?

Important features to consider in any electronic system that you may be considering should include, at a minimum:

  • Documented Part-11 and HIPAA Compliance
  • Limited access to data and documents to authorized users based on role
  • Complete Audit Trials
  • Compliant Electronic Signature Processes
  • Automated conversion or export methods for managed documents
  • Documented validation processes for Auditor Review
  • Remote monitoring and query systems

Moving from a paper-based system to an electronic system plays a pivotal role in moving clinical research forward and into a technologically advanced world. If you are interested in going paperless with RealTime’s compliant, feature-rich and user-friendly systems, give us a call and our team will take you on a complete tour! Schedule a FREE DEMO by calling (210) 852-4310 or fill out the form 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!

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!

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!

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.

09 Oct 2019

RealTime Software Solutions Announces They Have Joined SCRS Global Impact Partner Program

RealTime Software Solutions Announces They Have Joined SCRS Global Impact Partner Program

As a leader in clinical trial software, RealTime hopes to benefit sites, sponsors and CROs through a new partnership with SCRS.

As a dedicated leader in the clinical trial industry, RealTime Software Solutions is pleased to announce that they have joined the Society for Clinical Research Sites Global Impact Partner (GIP) Program.

RealTime CEO Rick Greenfield, a long-time member of SCRS, says the partnership is just another way for the company to come together with industry leaders to help streamline the way research is done.

“As a long-time attendee of the Site Solutions Summit and proud member of SCRS, I have seen first-hand the difference that SCRS has made for clinical research sites and the research industry as a whole,” says Greenfield. “I could not be prouder to bring RealTime into the GIP family at SCRS and to join the cause for better processes, systems and best practices that will improve the clinical research landscape for Sites, CROs and Sponsors alike. At RealTime, we prioritize the needs of the industry so we can offer solutions that truly make a difference. The GIP program gives us the opportunity to listen and contribute on a whole new level.”

As a member of GIP, RealTime will have the opportunity to work directly with major players in all facets of the clinical research industry to include large-scale CROs, data vendors, service providers, sites and site networks that all have a hand in shaping clinical research.

Members also benefit by having a seat on the GIP board which interfaces with SCRS leadership to set strategic initiatives for the Society. SCRS GIP members may also elect to engage the SCRS community for individual corporate objectives using SCRS program options that include focus groups, surveys, research, content development, and geographic or regional site support.

To learn more about RealTime Software Solutions, visit RealTime-CTMS.com.

About RealTime Software Solutions

Founded in February of 2013, RealTime Software Solutions, LLC strives to bring innovative Clinical Trial Management Systems (CTMS) to sites, CROs and sponsors of all shapes and sizes. The core values of RealTime include, “Innovation Now”, “Think Like Customers” and “Integrity Always”. These values have helped RealTime grow into a leading CTMS provider for systems like SitePAY, GlobalPAY, eDOCS and eSOURCE for thousands of customers around the world. RealTime will continue the pursuit of advanced systems and processes that enhance the workflow and efficiency of all stakeholders within the clinical research execution process. Visit RealTime-CTMS.com to learn more.

Contact Information

Brandy Haslam

ImageBloom, Inc.

http://imagebloom.com

210-254-7431

01 Oct 2019

Q&A with Rick Greenfield: RealTime-Enterprise

Large-scale research data can seem overwhelming in a data-driven industry. While managing a multi-site or extensive site network, centralizing processes and taking advantage of multiple resources across the network is the goal, but few systems on the market can truly bring this level of efficiency to a site network.  Aggregating data and providing valuable network-wide metrics for enterprise-level decision making and forecasting is another goal that is often difficult to make a reality. We had the opportunity to speak with Rick Greenfield, CEO of RealTime Software Solutions on the RealTime-CTMS Enterprise system and how it can help solve the above challenges and more.

Interviewer: What is RealTime-Enterprise?

Rick: RealTime-CTMS has enterprise-level platforms that can scale to meet the demands of the largest and geographically diverse site networks, hospital systems, and universities. Enterprise systems connect CTMS to allow for a perfect combination of separation. In regards to local resources and patient databases, these systems provide enterprise-level managers and officers with visibility across the network and aggregate data to track production, profitability, business development, and more.  Further, RealTime’s Enterprise systems allow for real centralization of processes such as finance and accounting, eREGULATORY processes, patient recruitment, and even eSOURCE creation and data collection.

Interviewer: Who can benefit from RealTime-Enterprise?

Rick: RealTime’s Enterprise systems can be found today in medium-sized multi-site networks with geographical diversity as well as extensive international site networks spanning multiple countries.  Because we have servers strategically positioned around the globe, we can also meet the strenuous and varying data privacy laws of countries such as Canada, Australia, New Zealand, the entire EU.

International Data Compliant Seal

Interviewer: How does RealTime-Enterprise differ from RealTime-CTMS?

Rick: RealTime-Enterprise leverages all of the tools of the RealTime-CTMS and SOMS products so that each site within the network can leverage the most powerful grouping of products on the market.  The RealTime-Enterprise platform connects sites for centralization and aggregation of systems and data.  In short, RealTime-Enterprise brings the best of the best CTMS solutions together into an unparalleled platform for network-wide management.

Large-scale data needs large-scale systems. RealTime-Enterprise brings systems and data together, like no other.  Find out how your medium to large-scale organization can benefit from RealTime-Enterprise systems to lead the shift to centralization and efficiency in the site network landscape!

Interested in a demo? Give us a call at 210-852-4310 or CLICK HERE to 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.