Category: eDOCS

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.

04 Apr 2018

S.O.M.S. for Leading Research Sites

You have probably heard the term S.O.M.S., but what does it mean?  Quite simply, SOMS stands for Site Operations Management System.  It rhymes with Tom’s… it’s SOMS!

OK, now you can say it, but what is it?  In the vast arena of software available for clinical research sites, there is a lot to navigate and a lot to consider.  The short list would include, CTMS systems, eRegulatory systems, Stipend payment systems, eSOURCE systems for data capture, TEXT systems for appointment reminders and other patient communications, direct mail systems, website study listing and application capture, CRM software for lead management, and more.

There is a lot to keep track of within all these systems.  Sites will need to establish contracts for each of these services/products, establish payment systems for each product, have trained personnel who can run each system, ensure login credentials are maintained and working, transfer data between these systems to perform their designed functions, etc.

With a SOMS system, all the above can be accomplished in one seamless information system. A SOMS system bundles each service into a single user-friendly platform that fully integrates with platforms like WordPress or other website CMS, MailChimp, Facebook and more.  The level of efficiency and cost savings that can be accomplished with this fully integrated system is unparalleled.

There is one other important thing to note.  There is only one vendor on the market that has a SOMS system and that is RealTime Software Solutions.  Individually, RealTime has best-in-class CTMS, eRegulatory, eSOURCE, TEXT, PAY, website integration, MailChimp and Facebook integration and other handy tools. RealTime also provides a user-friendly mobile app for doctor referrals, eSignatures on the go, quick access to study documents, eSOURCE data collection, as well as an Outlook plugin that allows for drag-and-drop documents into eReg binders or other eDOCS storage locations AND MORE.

While other vendors claim to have “integrations” or even similar bundling of software, be sure to compare the capabilities of each of their systems and how they stack up to RealTime’s solutions for each.  RealTime not only offers the best standalone solutions, but the only complete bundling of solutions into a single platform for ultimate efficiency, cost savings and production.  RealTime SOMS.  There is only one and it can be found in leading sites around the world!

Take a look at RealTime.  Choose the right system the first time.  But it’s never too late to make the switch.  Anytime you switch to RealTime, you are right on time. Schedule a demo today to learn how RealTime can help you streamline your processes and drive results. Call (210) 852-4310 or visit
realtime-ctms.com today!

25 Aug 2017

A mobile app that makes everything simple

As a clinical researcher, being at your desk to take care of study documentation, patient referrals and everything else that goes into managing your studies can be difficult and time-consuming.  That’s why our team has created a mobile app that lets you access all your files, contacts, patient referrals, and inclusion/exclusion criteria on the go.  RealTime-eDOCS has become an industry-leading eRegulatory system that streamlines the way sites, sponsors and CROs manage regulatory documents.

If you are a current RealTime user, you know how intuitive and user-friendly our solutions are. Our eDOCS mobile app is no exception! The eDOCS app is tailored to meet the needs of clinical research sites, staff and doctors.

Before the eDOCS mobile app, you would have to wait to get to your office in the morning to refer patients, sign documents, request signatures, manage contacts, and navigate your regulatory files.

Now with the eDOCS mobile app, all the information you need is at your fingertips!  Anytime, anywhere, you can review all regulatory documents for your studies, sign important documents with your fingerprint, refer patients into studies, access important staff and study contacts and more right from you tablet or phone.  No other eRegulatory system has this capability!  Whether you are moving to eRegulatory, or already using an eRegulatory system, make the move to eDOCS to maximize efficiency and cost savings.

What can the eDOCS mobile app do for you?

  • Manage signature requests on the go by receiving and sending notifications. The app allows you to quickly view or search your signature requests.
  • Instantly sign documents with fingerprint technology.
  • Refer patients to your CTMS, which will increase the number of referrals from your doctors and boost your recruitment efforts.
  • Navigate eRegulatory files.
  • Quickly access your study and staff contacts.

Call RealTime today for a demo of our eDOCS system and the mobile app.  See the future of eRegulatory being led by RealTime!  Click here to schedule a demo or call us at (210) 852 – 4310.

By the way, if you are an eDOCS or eDOCS LITE user, find the app on Google Play or the App Store.

14 Aug 2017

RealTime is Changing the CTMS Industry with First-of-its-Kind New App

Research sites can now access popular eDOCS solution on mobile device with new app

SAN ANTONIO—Want to access site eRegulatory files, sign documents with your thumb print, refer a patient to a study or look up site and sponsor contacts all on your mobile device? There’s an app for that!

RealTime-CTMS launched the first-of-its-kind new app this week that allows site staff to use its popular eDOCS solution from an iOS or Android device.

“No other CTMS or eRegulatory system has mobile capabilities like we do,” says RealTime-CTMS CEO, Rick Greenfield. “The ease at which sites can access pertinent information including inclusion and exclusion information, sign documents using finger print technology and even refer patients directly into the CTMS system can’t be matched.”

eDOCS is a cutting-edge system that can be fully integrated with RealTime-CTMS or used as a stand-alone system. The solution enables sites to go fully digital, eliminating messy regulatory binders and paper work. eDOCS has already made a splash in the clinical research world and with the release of the app, industry leaders are expecting the solution to continue to grow in popularity.

“Everything is going mobile, even the clinical trial industry,” says Greenfield. “With the tap of a button on your mobile device, sites now have instant access to information that would otherwise have to be found in bulky binders and loads of paperwork.”

Some features of the new app include the ability for investigators to sign documents using iOS and Android finger print technologies, easy access to site and sponsor contacts on the go and push notifications that alert investigative staff that requests for signatures are pending. The app also allows site staff to refer a patient into a study and instantly access protocol and study information.

“We are very excited about the launch of our app and believe it will greatly increase efficiency and success across our sites,” says Greenfield.

For more information on eDOCS mobile, download the app at the App Store or on Google Play.

About RealTime-CTMS

RealTime Software Solutions, LLC is located in San Antonio, TX and is a leader in database-driven, cloud-based clinical research software solutions. Our focus is on research sites and our goal is to solve problems and provide systems that make the sites more efficient and more profitable. We are constantly listening to our customers to provide new innovations that improve performance and help sites achieve their goals.

28 Apr 2017
EREGULATORY – A CHANGE WORTH MAKING

eRegulatory – A Change Worth Making

Let’s face it, change is hard. You get used to the way you’ve always done things and when someone talks about doing something different, you’re like a deer caught in headlights.

If you’re working at a clinical research site and have always used paper regulatory documents, changing to an electronic document solution may seem overwhelming and a bit scary.

But like Sheryl Crow said, “A change would do you good!”

In all seriousness though, there are some significant benefits of switching to an electronic document solution like RealTime-eDOCS. Sites that have made the switch are loving the user-friendly interface and ease of accessing eRegulatory documents all in one centralized location.

If your site is considering making the switch, read on to learn more about the benefits to your site.

1. Save time and money. We all love saving money and who doesn’t like to save a little time? Electronic documents eliminate the need for printing, filing, scanning and mailing as well as the need for storage space for bulky regulatory binders.
2. Remote monitoring. With an electronic document system, users can access and manage regulatory records remotely reducing the need for sponsor travel between sites. Best of all, documents are available with the click of a button anytime, anywhere!
3. Increase efficiency. From electronic signatures, the ability to set expiration dates for CVs, licenses and certification and the ease of accessing all documents in one centralized place to improved collaboration between investigators and sponsors, an electronic document solution increases efficiency from all angles.

Going paperless doesn’t have to be a challenge. If you’re already a RealTime customer, eDOCS is a fully-integrated solution that can be implemented quickly. If you are using another CTMS or don’t currently have a management system, eDOCS can be used as a stand-alone system!

Call us today to schedule a demo!

04 Oct 2016
realtime edocs outlook RealTime-CTMS Clinical Trial Management System

RealTime-eDOCS Now Integrates with Outlook!

Our industry-leading eRegulatory system just got better!  RealTime has built a custom Outlook add-in that integrates RealTime-eDOCS with your Outlook email.   RealTime-eDOCS customers now find it easier than ever to manage records and electronic signatures without leaving their email.

Game-changing features include:

Upload Emails and Attachments from Outlook to eDOCS
Quickly upload files from your email directly to your eDOCS system.  With our user-friendly Outlook interface, uploading files without leaving your email will save time.

Sign Records and Request Signatures Without Leaving Your Email
It’s now easier than ever to obtain signatures from staff and doctors. Upload your record from Outlook into eDOCS and request electronic signatures at the same time.  Once a signature request appears in your Outlook inbox, you can easily view and sign records straight from your Outlook email!

Automated Signature Tracking
Automated color-coding allows users to quickly categorize emails to easily separate pending signatures from completed signatures when navigating their inbox.

RealTime-eDOCS is changing the way that sites manage regulatory documents in clinical research. Learn more about RealTime-eDOCS on our website or contact us directly for a live online demo.

23 Sep 2016
Webinar RealTime-CTMS Clinical Trial Management System

Webinar Q&A From RealTime’s Product Manager Nathan Levens

Did you catch our webinar hosted by ClinEdge, “e-Regulatory Systems – Connecting Sites and Sponsors in a Whole New Way” from August? If not you can watch the recording here.

Nathan Levens answered several great questions during the webinar and received additional questions after the webinar ended.  Below are some additional questions addressed after the webinar.

Q: Where does the “original” ink signature end up? 

With Part 11 compliant electronic signatures, wet-ink signatures are no longer needed since the record can be signed electronically. Electronic signatures will create enormous efficiencies for your site. However, in the event that you do have a paper document with an original wet-ink signature, our system (RealTime-eDOCS) will allow you to scan that document as a certified copy. According to the FDA, certified copies are completely acceptable during an inspection or audit; therefore, your original wet-ink document can be destroyed. What you decide to do with your original paper document once it’s scanned and saved within eDOCS is up to your site’s standard process. The key is to establish a written SOP describing your process so that it’s clear to your sponsors and the FDA. While the most efficient process is to shred/destroy the document immediately after saving the certified copy, some sites decide to hold onto the wet-ink signatures and store them for a set time frame (e.g., 6 months down the road) or indefinitely. Simply do what’s best for your site.

Q: What is the percentage of sponsor’s/CRO’s that will allow sites to use eDOCs?

Your approach will greatly affect the number of sponsors/CROs that will share in the benefits of using eDOCS. Our experience has been that the sites that approach the utilization of eDOCS as a standard operating process within their organization are most successful. Since sites have every right to adopt an electronic system for their regulatory management, it’s important not to ask permission but simply let the sponsor/CRO know that this is the site’s uniform process.

To give you an example, one of our eDOCS customers who operates two successful sites has been utilizing an eRegulatory solution on 100% of their studies for greater than 18 months now. They have not lost a single study as a result their mandatory eRegulatory process.

To give you second example, another one of our sites is asking for permission to use their eRegulatory solution at the pre-study visit. By asking for permission, this give’s sponsors/CROs control over site processes. As you can guess, this strategy is far less effective and this site has received more push-back from sponsors/CROs.

It is important for sites to have a consistent and uniform process across all of their studies to ensure quality and compliance. The FDA paved the way for electronic systems to accelerate efficiency in our industry. It is not the sponsor’s place to dictate what systems sites should use for their site files as long as they meet FDA regulations. Further, sponsors often don’t understand the great benefits that come from utilizing these systems (i.e., remote access and monitoring, query tracking, increased collaboration, streamlined document review, etc.)

Sites around the world are already utilizing eRegulatory systems with great success and on 100% of their studies and this highly depends on the site’s approach.

Q: Can you give guidance on what to do when facing a sponsor who does not want to use a site because they use eReg

Please refer to the question above and develop a strategy. In the worst case scenario (less than 5%), the site can simply go with paper binders for that study; however, hopefully both you and the sponsor understand that this is a more costly way to go for both parties and will create inefficiencies by deviating from your standard process. Since you are stuck using paper in this scenario, nobody wins, including the sponsor, but at least you can keep business moving forward. Usually if a sponsor is not open to an eRegulatory system, it’s because they are not familiar with the benefits of the system to both parties; therefore, a strategy for articulating these benefits may change the sponsor’s mind. It’s good to ask them for the reasoning behind their decision against your eRegulatory system and lay out the benefits everyone will experience. From our observation, successful sites are those that engage the sponsor in meaningful conversation about why the site needs to use eDOCS to streamline processes for both the investigator and the monitor. During this conversation, sites can address the sponsor’s concerns and obtain buy-in. You can even offer to give the monitor a quick tour of the system so they can see the benefits it will bring. As a last ditch effort before deciding to go with paper, offer the sponsor a trial run to start the study electronic and mention that if they don’t like it for some reason then the site can quickly go back to paper. From our experience, showing sponsors the eDOCS monitor portal really helps obtain buy-in because it helps them visualize how the system will streamline their monitoring duties. The point is to try everything you can to give your sponsor a chance to get on board before resorting to paper. At the end of the day, eRegulatory systems will save the site and monitor valuable time which allows the research team to focus more on recruiting subjects and conducting visits, and allows the monitor more time to focus on subject data review, site training, and managing study resources. Everyone wins when sites make the shift to eRegulatory, but some sponsors need to be educated on this fact.

Q: Who needs to start the process? Do sites request from the sponsors?

Site-based eRegulatory systems reside at the site and the site starts the process of creating an eRegulatory binder and managing investigator records. All regulatory records that are received from the sponsor/IRB are uploaded to eDOCS by the site user rather than printing and filing into a paper binder. This eliminates the need for paper binders to manage the investigator site file. Once records are uploaded in the system, the site will issue web-portal access to monitors, auditors and FDA inspectors upon request to review the records.

Q: We are always at the mercy of what the sponsor wants. In our experience (we did a pre-test), sponsors do not want an “additional” system, and many of them require their system/portal. This is what seems daunting. I agree the problem should be solved at the site but what are others’ experiences in this? Sponsor requirements do not allow us to jump in with both feet.

Being “at the mercy” of the sponsor is a common feeling for research sites and I completely understand the frustration. Please know that while this is common, not all sites feel this way about their sponsors. The fact that some sites do not feel like they are at the mercy of sponsors shows that there is a way out of this trap and sites can absolutely take back control of their processes. This doesn’t mean that these sites never compromise with the sponsor, but it does mean that they fight diligently for processes that benefit their organization.

Furthermore, when a sponsor says that they do not want an “additional” system, it sounds like the sponsor doesn’t understand that a site-based eRegulatory system actually compliments their existing eTMF system/portal. This is a common misunderstanding by sponsors. From the webinar, I discussed that most sites still use the legacy system (paper-based binders) and upload copies of these paper records to sponsor systems/portals. What a site-based eRegulatory system does is replace the paper records with electronic records at the site. This allows sites to easily share the electronic files with sponsor systems/portals. Also, the monitor has the ability to download records straight from the site’s eRegulatory system to upload into their sponsor system. Nothing changes for the sponsor when a site uses a site-based eRegulatory system except the fact that they now have remote access to the records from anywhere with an internet connection. I have encountered this common misunderstanding when talking to sponsors at industry conferences. They ask, “Why do sites need eRegulatory systems when we already have an eTMF (electronic trial master file) portal that we provide to them?” The simple answer is that eTMFs are great for sponsors but do nothing to solve issues at the site-level. Sites are still having to find solutions to the paper-based investigator site files and a site-based eRegulatory system will provide these solutions.

Q: What should sites look for when evaluating eRegulatory systems?

The following are some items to keep in mind when shopping for a Part 11 compliant, site-based eRegulatory system; however, what matters the most is that the system truly streamlines your regulatory processes.

Check that the system truly reduces redundant filing for your site. Some systems don’t have a central location for common files and users still have to file the same records across multiple studies (i.e., CVs, GCP Training, etc.).

Ensure that the eSignature system is easy to use. Users should only be one or two computer clicks away from requesting signatures and/or signing a record.  The process should be intuitive and quick.

Monitors should have a way to track what they have reviewed within the monitor portal and be able to issue queries to communicate to the staff. This creates a lot of efficiency for your monitors and staff.  Plus monitors will be blown away at how the system makes their job easier.

Users should be able to customize their folder set up in their eRegulatory binders. This allows the site to create their own standard filing system and table of contents that works best for them.  Have a standard filing system will create tremendous efficiency over time.

In regards to signing an agreement with an eRegulatory vendor. Some vendors will make you agree to buy a set amount of studies (about 5-10) up front which locks you into the system.  If that system doesn’t work for you after trying it out, then you will still be locked in the agreement and owe money.  Beware of contract that lock you into a trap.

One last thing is to ensure that the system has an Outlook integration feature. This will streamline your record management processes because users can categorize records, upload files, and sign records electronically without leaving their email inbox.

Q: Are sponsors paying for site-based eRegulatory systems?

As an eRegulatory system does represent an additional overhead cost, many sponsors are willing to consider providing additional compensation to help cover the cost of the system.  Many sponsors do this knowing that the eRegulatory system will also provide efficiency and cost savings to them through streamlined monitoring processes and remote access to site files.  This additional compensation can be provided as a specific line item, increasing start-up/closeout fees, or even an increase in the budget overhead percentage.

However, even if the sponsor is not willing to provide additional compensation, this shouldn’t be a determining factor when deciding to adopt a site-based eRegulatory system for a number of reasons.  As I mentioned in the webinar, there are numerous hard costs and soft costs associated with paper-based regulatory processes that end up costing sites far more than the cost of an eRegulatory system.  Also, the opportunity costs are extremely high!  By streamlining your regulatory processes, your staff will be able to manage more studies from a regulatory perspective, plus your staff will gain more time to recruit participants and conduct study visits to generate more revenue for the site.  Also, if your staff is spending less time on shuffling paper records, they will have more time to focus on subject safety and adverse event follow up to maintain subject safety.

As a side note, most sites are either increasing their overhead charge or archiving fees for each study to accommodate the new system if they want to ensure some reimbursement for their eRegulatory system.  If the site’s overhead charge or archive fees are already relatively high and cannot be increased, then know that your new eRegulatory system is still streamlining your regulatory processes and decreasing your actual overhead over time and greatly reducing your need for physical archiving fees.

If you are interested in learning more about adopting an eRegulatory system to streamline your site’s regulatory processes, check out our industry leading product, RealTime-eDOCS™.  We have the system features and industry experience that will take your site to the next level in efficiency.

21 Jul 2016
eDocs-Lite RealTime-CTMS Clinical Trial Management Systems

RealTime Software Solutions, LLC Announces the Release of eDOCS-LITE as a Standard Feature for All Existing and New RealTime-CTMS Customers.

RealTime announces the release of eDOCS-LITE. This CTMS-integrated eDocument platform will provide a part-11 compliant document management system for sites. eDOCS-LITE is a free version of eDOCS that will have many of the great features of the full version of RealTime-eDOCS such as a Professional, Education and Training Tracking (PETT) system, an upgraded document management system, electronic signatures, complete audit trails, version control, study and subject document storage, and more. For the first time ever, sites can now have all of the features of a robust CTMS combined with an efficient document management system in a single, integrated platform. With a simple upgrade from eDOCS-LITE, customers can also enable the complete eRegulatory management system, RealTime-eDOCS, which has even more features and storage capacity to go completely paperless with regulator binders. Now, all in a single system, customers can have CTMS, PAY, TEXT, and eDOCS-Lite or eDOCS.

RealTime prides itself on bringing the most useful software solutions to the research industry. With intuitive interfaces and feature-rich designs, RealTime has exploded onto the clinical research market. New innovations are also on the way, including RealTime-GlobalPAY for stipend and travel reimbursement management at the Sponsor and CRO level. Follow us on Facebook, LinkedIn, and Twitter for updates on new innovations that help shape the industry.

About RealTime Software Solutions:
RealTime Software Solutions, LLC is located in San Antonio, TX and is a leader in database-driven, cloud-based software solutions. Our focus in on research sites and our goal is to solve problems and provide systems that make the sites more efficient and more profitable. We are constantly listening to our customers to provide new innovations that improve performance and help sites achieve their goals.

Contacts

RealTime Software Solutions, LLC
Rick Greenfield, 210-852-4210
CEO
rgreenfield@realtime-ctms.com

07 Jun 2016
Paradigm Shift RealTime-CTMS Clinical Trial Management Systems

A New Paradigm for Adopting Technology in Clinical Research

Traditionally, the clinical research industry has utilized a top-down model when adopting new technology.  In this model, sponsors and contract research organizations (CROs) have been seen as the innovators in the industry by adopting new technology and pushing that technology down to research sites for collection of records and data.  Instead of surfing the wave of technology that’s hitting the research industry, research sites have been spectators as the sponsors and CROs have all the fun.   This model has been both good and bad for the industry.  While some new technology is best implemented from the top-down, this model has created more efficiency for sponsors and CROs than it has for investigator sites, specifically when it comes to electronic regulatory systems.  These well-intended systems seem to focus more on what is easiest for sponsors and CROs to receive their records from sites and less on what will be most efficient for investigators to actually collect and maintain those records on-site.  The main end-users of this technology, investigator staff, seem to be left out of the equation.

To truly increase efficiency in the clinical research industry, it’s time that the industry opens up more to a bottom-up model of adopting technology.  In this approach, research sites are able to compliment certain sponsor/CRO technologies by adopting their own standard electronic systems (e.g., eRegulatory).  This approach allows investigator sites to reduce their workload while making records easily accessible by sponsors/CROs.   While the top-down approach for adopting technology has helped our industry advance in numerous ways, research sites also desire to be innovators.   Most importantly, research sites want to adopt technology that streamlines their own company processes and increases their viability as a business.  After all, an efficient and profitable site will produce better quality research data, increase their ability to monitor subject safety, and ensure its ability to thrive and continue to serve the advancement of medicine.  When sites adopt site-centric technology and take control of their own company processes, the sponsor, CRO, investigator, study participants, and society as a whole all win in the process.

Electronic regulatory systems from the top-down model typically lack key features that are needed to reduce the workload for research sites.  In fact, these systems most likely add additional workload and increase redundant filing since sites still have to file mounds of paper records to maintain a complete investigator site file.  Upon further inspection, these top-down systems typically limit the amount of users that a site can have which limits collaboration within the research site.  These systems also routinely lack electronic signatures and centralized filing for common records.  On top of these issues, sites are being asked to complete lengthy training sessions on multiple systems with several sponsors which leads to a laundry list of usernames and passwords to memorize and a variety of filing processes to follow.

All of these issues, and more, can be resolved with site-centric technology.  With our experience implementing RealTime-eDOCS™ with our customers, many sponsors and CROs are already leading the way on this issue by fully engaging with innovative sites that adopt their own regulatory document management system.  With the right eRegulatory system, sponsors realize that they gain as much benefit as the research site.  Site-centric technology shouldn’t be feared by sponsors or CROs but should be embraced.

At RealTime Software Solutions, LLC we are actively pushing for a bottom-up approach to solve issues that research sites face every day while also improving relationships between sites, sponsors and CROs.  The top-down model is very dominant in our industry but RealTime’s affordable solutions are now changing the paradigm and giving research sites the technology they need to regain control of their process and improve the research industry.