s

Tag: eDOCS

01 Mar 2021

Behind the Software with Evelyn Jackson

Each of our RealTime-CTMS team members are crucial to the success of our company. Without their hard work and dedication to success, we wouldn’t be who we are today. Each month, we are excited to showcase one of our amazing team members in a Behind the Software feature. This month, we are featuring our eDOCS Product Manager, Evelyn Jackson!

Evelyn has been with RealTime since 2019. She is dedicated to leading the eDOCS team in outstanding customer support, maintaining eRegulatory compliance, and providing solutions with a purpose. Now, let’s go Behind the Software with Evelyn!

What’s a perfect day off from work look like for you?

Sitting on the beach with my toes in the sand looking out over the ocean. In my opinion, hearing and seeing the waves of the sea is one of the most relaxing things in the world.

Have you learned any new skills during the pandemic?

I am learning to balance my work/life schedule. I know there can never be a true balance 100% of the time, but acknowledgement, daily pursuit of that balance or any type of growth for that matter, are a step in the right direction.

What is your favorite emoji?

 Dancing Monkey​​​​​​​

Do you have any pets?

Shitzu-Yorkie named Macie.

If you could only eat one food for the rest of your life, what would it be?

If we are not coming from a health standpoint, I would say…Tacos.

What is one of your favorite movies?

The Count of Monte Cristo

What is the top location on your travel bucket list?

Anywhere in the Mediterranean, but in all honesty, my dream is to travel the world, one vacation at a time. My husband would say that I am a dreamer, but little does he know that this will soon be his reality.

What’s your go-to karaoke song?

I do not have one; even though I sing regularly on a church praise team, you will rarely see me volunteer to participate in karaoke.

Do you have any hidden talents?

I would consider myself fair at archery.

What do you like most about your job?

I love that my position at RealTime is not only a workplace to earn a living, but it is an environment I can grow and spend time with a great group of people that are passionate about what they do.

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

26 Jan 2021

Make the Switch in 2021 to RealTime-CTMS

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

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

SOMS (Bundled Solutions)

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

eSOURCE

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

eDOCS

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

SitePAY

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

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

19 Oct 2020

3 Tips for Staying Audit-Ready

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

Create

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

Prepare

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

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

Execute

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

Conclusion

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


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

26 Jun 2020

5 Things to Look for in an eRegulatory System

Due to increasing demand and shift to paperless research systems, it is vital to ask the right questions when searching for a site-based eRegulatory system. Sites can utilize eRegulatory systems to streamline regulatory processes, maximize cost-effectiveness, and make study information more accessible. These are some basic questions to ask when searching for an eRegualtory system.

What should I look for in an eRegulatory system?

Comparing the features and capabilities of eRegulatory systems is critical. Below are some essential things to consider as you evaluate various eRegulatory systems available:

User Experience

User experience can make a huge difference when accessing your eRegulatory files. An eRegulatory system should provide an intuitive and user-friendly experience. Everything from navigation, document versioning, eSignatures, and more are all features that make the user’s job easier.

Monitoring Portal

Today, a remote-monitoring portal in clinical trials can be an excellent benefit for all parties. These portals allow sites to upload regulatory documents for remote review, provide for query management, document versioning, document downloads, and more.

Secure Centralized Filing

An essential factor to consider is the safety of your documents. Your eRegulatory system should highly secure and meet or exceed all industry standards for data hosting and security.   These standards include data encryption, redundant storage, robust back-up systems, disaster recovery planning, third-party penetration testing, and more.

Compliance with Part-11 and HIPAA

Your eRegulatory system should meet FDA Part-11 and HIPAA compliance, which includes essential features such as user audit trails, software validation, compliant eSignatures, and much more. These compliance standards are verified by the FDA and must be present during an audit.

Customer Support

When making the switch to paperless eRegulatory systems, you need guidance and support to ensure a smooth transition.  Ensure that your vendor not just claims to provide excellent support but has numerous customer references to back it up.  Additionally, all training and support services offered by the vendor should be clearly defined in your software agreement.

When choosing an eRegulatory system, ask for a complete demo. A full demo can give you a solid understanding of the features, capabilities, and user-friendliness of the software and upcoming features on the vendor’s product roadmap. Finally, before signing, look out for hidden storage fees or long-term, binding contracts.

User-friendly features, excellent customer support, and remote-monitoring capabilities are the tip of the iceberg when it comes to RealTime-eDOCS as an eRegulatory system. If you are interested in scheduling a free demo of RealTime-eDOCS, an industry-leading eReg solution, give us a call at (210) 852-4310 or click 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!

27 Aug 2019

Segal Trials Announces eRegulatory Milestone with RealTime-eDOCS

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

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

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

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

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

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

19 Apr 2019

ACRP 2019 – Key Takeaways (and Bandanas)

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

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

The Paperless Site –eSOURCE and eREG

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

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

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

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

What was your favorite part of ACRP?

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

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

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

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

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

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

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

11 Apr 2018
what to look for in an eRegulatory system

Searching for an eRegulatory system? Here’s What to Look For

A few years ago, eRegulatory systems were nothing more than sponsor-fed trial master files requiring sites to complete double, and sometimes triple, the amount of work.  Anytime site regulatory personnel heard “electronic regulatory” they cringed at the idea of interrupting their day-to-day flow to maintain these systems in addition to their paper binders.

Due to these past experiences, the benefits of site-based eRegulatory systems were hard to imagine.  With the introduction of new technology and advanced software systems to support it, sites now have every opportunity to utilize eRegulatory systems to streamline regulatory processes, maximize cost-effectiveness, and make study information much more accessible to all parties like never before!

Why the change to eRegulatory?

The transition to eRegulatory in our industry can be largely attributed to advancements in technology and the “mobile revolution,” providing individuals access to the internet and advanced mobile features in the palm of their hands.  eRegulatory software has been designed to make clinical research more efficient by capturing electronic signatures, reducing the need for repetitive filing and clerical work, reducing paper and storage costs, and providing site’s consistency from study binder to study binder.

In the last few years, the industry’s attitude towards eRegulatory has shifted and now a rapidly growing number of sites embrace these new technologies to cut costs and increase efficiency. The development of innovative technology from mobile apps to user-friendly software has enabled sites and sponsors to save time and money while keeping all the important documents in one place, eliminating redundant tasks and reducing the possibility of human error. It is the combination of advanced technology and smarter software, that has allowed sites to truly move towards a paperless environment.

What should I look for in an eRegulatory system?

All eRegulatory systems are not the same.  Comparing the features and capabilities of systems is critical, so you have to know what to look for to make a good decision.  Below are some of the primary things to consider as you evaluate the various eRegulatory systems on the market:

User experience: User experience is one of the most important considerations when looking at systems. An eRegulatory system, designed to replace well-established paper systems, needs to provide an intuitive, efficient and user-friendly experience.   Everything from navigation, document upload, Outlook integration, drag-and-drop folder and document sorting are all features that make the user’s job easier.

When it comes to features, there is a lot to consider when evaluating various systems.  Here are some of the primary features that you may want to consider:

Reg Binder Format Template Set-up: The ability to set up your unique folder structure for your company’s regulatory binders that follow your specific company SOPs.

Document Versioning Control: The ability to track versions of documents.  For instance, protocol and ICF updates that show the succession of documents, oldest to newest, and prevents users from accidentally accessing an old version of a file for current use.

Document Expiration Tracking and Notifications: Having the ability to assign an expiration to a document and system notification to alert your staff that a document has expired and needs updating.

eSignatures: Part-11 Compliant eSignatures for all study documents including capturing multiple eSignatures on documents, Outlook eSignature integration capabilities, and mobile app eSignature capture.

Mobile App: A mobile app that allows staff to view all regulatory documents, eSign documents as requested, review study inclusion/exclusion on the go and refer subjects with a click of a button in the mobile app. (Download the RealTime Mobile App in the App Store or Google Play)

Outlook integration: An integration that allows your staff to connect directly with their eRegulatory system to drag and drop documents into the regulatory binders, eSign documents and more

Monitoring Portal (multiple role types) (query system): Having a monitor/auditor-specific portal for multiple monitors/auditors that allow for complete document review, issuance of queries that alert staff, and a way for staff to respond and resolve issued queries.  These portals allow monitors/auditors to have remote access to the eRegulatory binders which will cause your sponsors and CROs to fall in love with your eReg system.

Central Documents: A place to store non-study-specific documents such as temperature logs, company training, calibration records, etc.  Central documents should be easily pushed to study binders as-needed.

Staff Documents: A professional, educational, and training tracking system (PETS) to store the documents for each staff member, study provider, investigator etc.  These documents would include CVs, licenses, GCP training, IATA certifications and more and would easily be pushed into all studies that the staff member is associated with for view by monitors and auditors.  Of course, staff documents should also have version control and expiration dates tracked.

Subject Documents: A place to store subject-specific documents such as medical records, signed ICFs, and other study-specific subject documents.

Compliance with Part-11 and HIPAA:  In order to meet FDA Part-11 and HIPAA compliance, your eRegulatory system must provide several important features such as User Audit Trails, User Password Rules and Controls, Encryption of Data in motion and at rest, validated software, and compliant eSignatures, just to name a few. These are required and will be verified by the FDA and must be present during an audit.

Additionally, only a few eRegulatory systems on the market have third-party Part-11 review documentation that confirms that all of these requirements are met.  Don’t gamble your site’s integrity with a system that does NOT have a validated third-party assurance letter.

Communication/Integration with other systems: The last thing site personnel need is yet another portal to log into.  Will your site team have to launch into multiple systems to manage eRegulatory subject recruitment, CTMS, or pay accounts, each with a different username and password?  Having to function in multiple systems will put a strain not only on user experience but possibly work productivity itself.

The idea of using one system and one login to access all your sites needs is completely possible and being able to pair products and system integrations are key.

Customer Support: With the idea of pairing separate products and integrating systems together comes the need to access different software support teams. However, if you are using two different systems (i.e., CTMS and eRegulatory by different vendors) you will likely not enjoy the same level of integration and features that would come from having both systems in the same platform by the same vendor.  Your staff will also have to work in separate systems even if there is some level of integration for sign-on and data sharing.

Pricing, pricing, pricing! Maximizing cost-effectiveness also includes pricing. eRegulatory systems typically have a start-up, in addition to a per-study fee.  Those rates can possibly be adjusted depending on other products you use with the company or if you are contracted for a set amount of studies.

Contracts can be a bit tricky though.  Be aware of contracts that lock you into a lower rate for the per study fee but obligate you to use their system, whether you like the system or not, until you reach your set amount of studies.  Some systems charge annual storage fees per study, so over time you may be paying a very large annual fee for storage that will grow larger each year.  These storage fees can really add up so consider a system that has no annual storage fees!

When choosing an eRegulatory system consider asking for a demo to test the interface and the overall user experience. Be sure to inquire about possibilities of integrating with other systems and if they’ve had issues with connectivity in the past. If this is the case, ask how long it would take to solve said connectivity problems. Finally, before signing, look out for hidden storage fees or binding contracts.

Unparalleled user features and experience, great customer support, and competitive pricing are just a few of the advantages of RealTime-eDOCS for paperless eRegulatory. All of our solutions (CTMS, eDOCS, eSOURCE, TEXT and PAY) can be used as stand-alone systems or can fully-integrate with each other! If you are interested in learning more about our products call (210) 852-4310 or click HERE.