Tag: eregulatory

06 Jul 2020

FAQ: Compliance in Paperless Research Systems

Why does compliance matter when using an electronic system?

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

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

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

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

The Shift to eREGULATORY and eSOURCE Systems:

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

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

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

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

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

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

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!

31 Mar 2020

Utilizing Remote Monitoring Study Portals Through a Pandemic

During this challenging time, maintaining clinical trial progression is a novel challenge as on-site data and regulatory reviews are either impossible or extremely limited. Travel limitations and “stay home” initiatives across the country have hindered the way clinical trial data is handled. Many clinical research sites and sponsors are left without the data records needed to conduct safe and timely trials.

RealTime’s eSOURCE and eDOCS could be the solutions you are looking for to maintain visibility, data integrity, subject safety, and keep operations moving. RealTime systems provide complete monitoring portals to review eSOURCE data and eRegulatory data. These portals allow sites to upload their source documents and regulatory documents for remote review, provide for query management, document versioning, document download, and more. Here are the key features that RealTime can rapidly deploy:

  • Source Document and Regulatory Monitoring portals – Online access allows Sponsors to collaborate more effectively during trials and streamlines monitoring activities.
  • Query Management – Sponsors can review, track, and issue queries on records from the monitoring portal. Sites communicate directly to the monitor for a quick resolution.
  • Document Version Control – Source documents can be uploaded by sites using our document control feature.
  • eSignatures – Electronic signatures dramatically increase efficiency when gathering staff/doctor signatures. This feature also maximizes subject safety oversight by allowing more timely doctor assessments on lab reports, ECGs, and other critical documents.
  • Part-11 Compliance – Our systems are secure, validated, and ready to go! Complete audit trails and data controls are maintained within the system for users to reconstruct the time of events and prevent human errors during data collection. These features improve accountability and data integrity.
  • Secure Cloud Hosting – All records are stored with a thorough data security/backup plan and encrypted for maximum security.
  • Built-in Reports and Notifications – Quickly review queries across all records, including query statuses.

 

Here at RealTime, it is our goal to help guide you through this moment and get your clinical trials back on track. We are here to help. Give us a call at 210-852-4310 or CONTACT US to learn more!

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.

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.