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Category: eDOCS

28 Feb 2020

5 Reasons Why Your Site Should Be Using Paperless Systems

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

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

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

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

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

14 Feb 2020

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

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

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

Advertising Mastermind

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

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

Leads, Leads, Leads!

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

“Can you text me?”

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

Recruitment Powerhouse

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

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

25 Nov 2019

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

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

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

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

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

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

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

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

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

27 Aug 2019

Segal Trials Announces eRegulatory Milestone with RealTime-eDOCS

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

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

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

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

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

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

19 Apr 2019

ACRP 2019 – Key Takeaways (and Bandanas)

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

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

The Paperless Site –eSOURCE and eREG

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

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

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

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

What was your favorite part of ACRP?

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

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

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

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

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

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

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

01 Apr 2019

Behind the Software with Alyssa Arce

One of the things we strive for at RealTime is building a team of people who are passionate about the industry and dedicated to providing exceptional customer support. Our goal as a team is to give back to clinical researchers by creating software that is more efficient, reliable, and easy to use. This month, we feature one of our incredible team members, Alyssa Arce.

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

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

1. What is a hidden talent you have?

I make great tamales.

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

Grind.

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

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

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

Growing a human.

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

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

6. What are the values that drive you?

Kindness, personal growth and communication.

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

Relaxation and self-care.

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

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

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

05 Nov 2018

5 Ways that CTMS Can Add Value to Organizations

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

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

How can CTMS add value to organizations?

  1. Recruitment Tools

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

  1. Build Your Database

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

  1. Improve Site Efficiency

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

  1. Software Integration

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

  1. Track Financials

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

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

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

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

24 Oct 2018

Key Takeaways from SCRS 2018

Assembling for a cause

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

Powerful words

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

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

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

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

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

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

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

What was your favorite part of the SCRS experience?

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

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

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

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

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

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

26 Aug 2018
Paperless Nirvana Blog - RealTime-CTMS

Achieving Paperless Nirvana

Let’s face it, we have a paper problem.

In a recent webinar, RealTime’s CEO, Rick Greenfield spoke about the existing “paper problem” in the clinical research industry and ways that we can overcome it to achieve “Paperless Nirvana”.

As you already know, the Clinical Research Process primarily functions off of paper source documentation and manually transcribed data into EDC systems. Paper has been the standard for source documentation and regulatory processes for years, but these systems are far from efficient and change is overdue.

The Paper Problem

Using paper to conduct your research processes puts your site at a higher risk of inefficiencies and inaccuracies. This may happen as a result of:

  • Delay in data receipt and review by the Sponsor or CRO.
  • Time and travel expenses of on-site review of source and regulatory documentation.
  • High probability of transcription errors from paper source to EDC.
  • Data concerns: Punctual, Accurate, Complete, True.
  • Increased opportunities for poor clinical practices, delayed investigator oversite and fraud.
  • Coordinators and staff chasing doctors for wet-ink signatures.
  • Paper-based central files such as staff professional documents (i.e., Licenses, CVs, Certifications, Training Trackers), temperature logs, equipment calibration records are all kept in paper files and must be maintained.
  • Separate reminders must also be maintained to ensure that records are kept up-to-date and don’t expire.
  • Regulatory filing into three-ring binders.
  • Extensive office space requirements to hold bookshelves full of study patient charts and other study files can become very costly, not to mention the cost of efficient printer/copy machines and supplies.
  • Long-term storage requirements of paper files (typically 15+ years).
  • Paper records run the risk of getting damaged or lost.
  • Redundant electronic, non-Part 11 compliant, storage systems to store document copies and drafts.

In addition to causing inaccuracies, paper processes increase the risk of fraud such as data and signature forgery.

Although all these problems have existed for years, adopting a paperless process is not as simple as it sounds, because like any other process in the clinical research industry, paperless platforms have to comply with FDA regulations, accepted eSignature processes, HIPAA and HITECH regulations and more. Building and adopting these compliant systems requires a concerted effort and time to complete.

Additionally, overcoming the natural resistance to change that may come from sites, sponsors and CRO alike can create even further challenges to the adoption of these new systems.

The Solution
Change is not easy, but it is necessary. Advancements in technology and newly adopted customer-centric approaches are making it possible for companies to build software that will improve the workflows that are beneficial for all parties (Sponsors, Sites, CROs, IRBs and the FDA).

Paperless Nirvana

With systems such as eSOURCE, eREGULATORY, ePAYMENT, eCONSENT, automated data transfer to EDC, electronic drug accountability and lab kit tracking and portal monitoring for all types of reviewers, we are one step closer to achieving paperless nirvana.

If all technologies are adopted by sites around the country and the world, data will flow faster than ever, data quality will improve, site efficiency will be accelerated, data and regulatory review will be accomplished in real time and we will see sites and studies go completely paperless.

RealTime’s Contribution

At RealTime, we believe that the customer’s needs come first. That’s why all our solutions have been created with extensive research and support from sites, Sponsors and CROs around the world.

We focus on efficiency, super customer service and helping our clients from study-start to finish. As part of the paperless nirvana initiative, RealTime has created solutions that communicate with each other and will help each site customize them to their specific needs.

For more information about how to achieve paperless nirvana at your site, call (210) 852-4310 or text PAPERLESS to 74-121. To view all our solutions and S.O.M.S click HERE.

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.