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Category: eDOCS

19 Oct 2020

3 Tips for Staying Audit-Ready

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

Create

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

Prepare

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

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

Execute

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

Conclusion

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


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

01 Oct 2020
realtime ctms scrs global site solutions summit 2020

RealTime is Making an Impact at SCRS 2020

This October, RealTime Software Solutions is proud to partake in SCRS Virtual Global Site Solutions Summit! With a full virtual events and workshops schedule, we wanted to share the sessions we are most excited about.

Tuesday, October 6, 2020 | 2:45 – 3:45 EST

Site Business Health: Withstanding Disruption During a Pandemic

Many clinical research sites know their finances and take the necessary steps to prepare for disruptions. In this session, we will hear from business owners what strategies they practiced before and during the pandemic. We will hear from several speakers, including Kay Scroggins, RN, President & CEO, Clinical Trials of Texas, and William Smith, MD, MBA, CEO, Alliance for Multispecialty Research.

Thursday, October 8, 2020  1:30 – 3:45 EST

Breakout Session: Risk-Based, Centralized, Remote Monitoring, Say What? Quality Control, Explained

If centralized and remote site monitoring (RSM) wasn’t yet on your radar, the COVID-19 pandemic brought it to you. But what exactly is RSM and what do they mean for sites? We are eager to hear speakers including Beenu Kapoor, MBA, MS, Vice-President, IQVIA and Summer Iverson, MSHS, CCRA, Process & Standards Lead Global Site and Study Operations, Pfizer discuss more on this crucial topic.

Friday, October 16, 2020 | 12:15 – 1:15 EST

Mater Workshop: The Transition to Paperless Technology in Clinical Trials

As a result of Covid-19, the industry has rapidly adopted paperless systems to allow for electronic source, paperless regulatory site files, remote monitoring, virtual visits and more. This webinar will explore the great benefits these systems have brought to our industry during this challenging time and address the opportunities that have arisen. We will also openly discuss these systems’ long-term impacts for sponsors, CROs, and sites as we move into a completely paperless world. Our very own Rick Greenfield BBA-IS, CEO, RealTime CTMS, and Nathan Levens, Director of Virtual Solutions & Technology, RealTime CTMS, will be presenting the workshop.

RealTime Software Solutions Global Site Solutions 2020 Video

We are excited to be presenting a breakout video during the virtual conference. You can view the entire video here: https://youtu.be/8TFzGv3QpIM.


RealTime is excited and proud to be a sponsor of SCRS Global Site Solutions Summit. To view the full agenda for the summit, click HERE. To learn more about RealTime and our innovative software solutions, visit realtime-ctms.com. Schedule a demo with one of our product specialists by filling out a contact form or call 210-852-4310.

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!

30 Mar 2020

San Antonio based software company keeping clinical research moving amid COVID-19 crisis

San Antonio, TX – As COVID-19 clinical trials start to ramp up around the country, the research industry has struggled to continue operating. As more and more cities implement orders to shelter in place, the way clinical trials are monitored has faced a challenge.

RealTime Software Solutions, a San Antonio based software company, is giving the industry a facelift that may forever change how research is conducted. Clinical trial monitors have historically visited research sites in person, collecting and monitoring crucial trial data. As most (if not all) sponsors and contract research organizations (CRO) have halted travel, and many sites limiting access to their locations, the need for other options have emerged.

“Sponsors and CRO’s are facing serious challenges in gaining access to study data and regulatory documents for important monitoring activities,” says Rick Greenfield, CEO of RealTime. “A rudimentary, inefficient and non-regulatory compliant solution, is for sites to scan and email these confidential and highly sensitive documents to the monitors for review.”

In steps RealTime.

“RealTime is now implementing emergency measures and spinning up complete portals for sponsors and CRO’s to deliver monitoring systems to their sites,” says Greenfield. “This will allow a quick and easy option for sites to upload data source and regulatory documents for review.  These systems are FDA Part-11 and HIPAA compliant, and provide excellent categorization and version control of uploaded study data for efficient monitoring.”

RealTime portals also include two-way data monitoring communication to maintain a strong connection between the sites and study-management personnel.

“This is such a challenging time for the entire world, and we are all trying to make sense of the massive change that has taken place in our society and the global economy,” says Greenfield.  “Just like everyone else, we are looking for ways to help and we are thankful to have been working for the past several years on systems that can provide a major benefit to the clinical research industry at this most critical time of need.  I urge all Sponsors and CROs to reach out to RealTime as we can deliver a complete monitoring portal to run multiple clinical trials for an unlimited number of sites within 48 hours.  We can train on the usage and have these systems fully operational in less than a week.”

RealTime has been at the forefront of clinical research technology, providing cutting-edge software to an industry that has been somewhat antiquated. This latest technology may change how trials are conducted and monitored, allowing a more streamlined approach.

“If we can keep clinical research moving with absolutely no additional risk to sponsor/CRO staff, then we can keep searching for better treatments and cures when they are most needed,” says Greenfield.

To learn more, visit realtime-ctms.com or call (210) 852-4310.

About RealTime

RealTime is a leader in advanced clinical research software with leading Clinical Trial Management Systems (CTMS), eSOURCE and eDOCS portals for completely paperless clinical trials.  The value of these systems is shining bright during this difficult time and allowing clinical research to continue for the benefit of medical advancements to include COVID-19 vaccine and treatment studies.

Call RealTime today at (210) 852-4310 or email info@realtime-ctms.com to learn more about remote monitoring portal delivery.

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.