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Tag: clinical trial management

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!

20 Jan 2020

Advanced Clinical Research Systems: The Top-Down Approach

The clinical research process, especially as it relates to data, primarily functions off paper source documentation and manually transcribed data into EDC systems. Most clinical research sites are still utilizing paper regulatory processes. Due to these primarily paper-based systems, there are numerous inefficiencies and detriments to the speed and accuracy of the clinical research process. So why are many sites still using paper-based research systems?

The Problem

As it relates to advanced research systems, FDA regulations have paved the way for electronic document storage, eSignatures, and electronic data capture. However, there is still an evident uncertainty in the industry about the FDA’s acceptance of a paperless process. The slow adoption of these advanced systems, unfortunately, is holding back the clinical research industry from a much more efficient and cost-effective future.

The Top-Down Approach

The Top-Down (or sponsor-driven) approach to adopting advance research systems has proven to be a long-winded process. Adherence to site policies and procedures for data accuracy, GCPs, regulatory compliance, and protocol compliance makes transitioning to paperless systems a significant hurdle. Current top-down systems do not have the user’s (site staff and doctors) needs in mind regarding workflow and ease of use.

The Solution

The shift to advanced research systems such as eDOCS and eSOURCE is inevitable. Additionally, EDC vendors need to help pave the way by offering intuitive data sync capabilities that will bring value to all parties and keep EDC companies relevant in this inevitable shift. As sites adopt site-based eSOURCE and eDOCS systems, the need to efficiently transfer files and data into sponsor-managed eTMF systems and EDC systems will become imperative. The pendulum has shifted!  Advanced electronic systems are proving their value across all organizations!

So, what are you waiting for?

Take the next step to adopting advances research software solutions! RealTime Software Solutions can transcend organizational boundaries, improve efficiency, and act as a seamless portal for all site operations.

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

To learn more about going paperless, fill out a CONTACT FORM, or call 210-852-4310 to speak to an expert today!

19 Dec 2019

Artificial Intelligence in Clinical Research

Emerging software and artificial intelligence in clinical trials are transforming the way research is being conducted. These digital advancements can help to improve, accelerate, and simplify the clinical trial process that we know today. How can your site take advantage of these artificial intelligence capabilities and power your site’s research efforts? Let’s dive deeper into the future of clinical trials.

Subject Referral Coding

When it comes to tracking study recruitment efforts, analyzing and understanding results can be challenging. Automatic referral coding powered by AI can simplify recruitment efforts. With RealTime-AI, subject referrals are automatically coded to specific campaigns. For example, a person sees your study on Google; they click on the ad and apply to the study. That subject has automatically been coded as a Google Ad referral and dropped right into your CTMS study roster. There’s no need to ponder where your leads are coming from!

artificial-intelligence-clinical-trials-ctms

Automated Follow-up and Scheduling

Following up with fresh leads can be crucial for a successful study. RealTime-AI makes it easier for the site to follow up with new leads. AI notifications are sent to new leads via email and text, ensuring prompt follow-up and the opportunity for a phone screening. Text reminders and re-scheduling are sent to subjects automatically, reducing no-show rates!

Financial and Milestone Tracking

As any site administrator knows, study financial tracking is a time-consuming process. Manually entering study financials is now a thing of the past with Artificial Intelligence. RealTime-AI automates screen-fail max and ratio identification with intuitive revenue and cost adjustment based on contract terms. When a milestone is completed, an auto-notification is sent out to the entire site staff.

RealTime-AI has capabilities that can function on a single site, multi-site, or enterprise level. Add on features such as eDOCS, eSOURCE, TEXT, and SitePAY, can power your site and make the clinical trial process easier than before!

Learn more about our RealTime-AI by scheduling a demo with one of our experts. Call 210-852-4310 or visit https://www.realtime-ctms.com/contact/ for more information!

01 Oct 2019

Q&A with Rick Greenfield: RealTime-Enterprise

Large-scale research data can seem overwhelming in a data-driven industry. While managing a multi-site or extensive site network, centralizing processes and taking advantage of multiple resources across the network is the goal, but few systems on the market can truly bring this level of efficiency to a site network.  Aggregating data and providing valuable network-wide metrics for enterprise-level decision making and forecasting is another goal that is often difficult to make a reality. We had the opportunity to speak with Rick Greenfield, CEO of RealTime Software Solutions on the RealTime-CTMS Enterprise system and how it can help solve the above challenges and more.

Interviewer: What is RealTime-Enterprise?

Rick: RealTime-CTMS has enterprise-level platforms that can scale to meet the demands of the largest and geographically diverse site networks, hospital systems, and universities. Enterprise systems connect CTMS to allow for a perfect combination of separation. In regards to local resources and patient databases, these systems provide enterprise-level managers and officers with visibility across the network and aggregate data to track production, profitability, business development, and more.  Further, RealTime’s Enterprise systems allow for real centralization of processes such as finance and accounting, eREGULATORY processes, patient recruitment, and even eSOURCE creation and data collection.

Interviewer: Who can benefit from RealTime-Enterprise?

Rick: RealTime’s Enterprise systems can be found today in medium-sized multi-site networks with geographical diversity as well as extensive international site networks spanning multiple countries.  Because we have servers strategically positioned around the globe, we can also meet the strenuous and varying data privacy laws of countries such as Canada, Australia, New Zealand, the entire EU.

International Data Compliant Seal

Interviewer: How does RealTime-Enterprise differ from RealTime-CTMS?

Rick: RealTime-Enterprise leverages all of the tools of the RealTime-CTMS and SOMS products so that each site within the network can leverage the most powerful grouping of products on the market.  The RealTime-Enterprise platform connects sites for centralization and aggregation of systems and data.  In short, RealTime-Enterprise brings the best of the best CTMS solutions together into an unparalleled platform for network-wide management.

Large-scale data needs large-scale systems. RealTime-Enterprise brings systems and data together, like no other.  Find out how your medium to large-scale organization can benefit from RealTime-Enterprise systems to lead the shift to centralization and efficiency in the site network landscape!

Interested in a demo? Give us a call at 210-852-4310 or CLICK HERE to fill out a contact form!

31 Jul 2019

Stipends in Clinical Trials: 4 Reasons Why You Need a Secure Payment System

An important part of any research participant’s participation in a clinical trial is knowing that they will receive their stipend payments for the time and contributions that they invest in a study. The truth of the matter is that no matter the amount, it’s important to make sure patients get paid in a timely manner.  Timely stipend payments help to increase subject compliance, and ultimately, improve study timelines and outcomes.

Making the decision to move to an electronic stipend payment system can provide many benefits, not just to the study participants, but for the site as well. Here are four things to consider when evaluating the benefits of moving to an electronic stipend payment system.

1. Reduced Costs and Improved Security

Initially, the transition to an electronic stipend system may seem more costly and more difficult to manage, but the reality is that the time-savings to staff and the built-in accountability that these systems provide save money and help to ensure greater transparency and security.  Some questions you want consider when looking at a stipend payment system are:

  • Does it integrate with your current CTMS?
  • Is it secure, and how does it prevent fraud?
  • Is it user-friendly and patient-friendly?
  • What are the reporting options?

Each one of these above questions will help you make the right decision and provide a better experience for site bookkeepers and staff as well as the clinical trial participants.

2. Streamlined Payment Processes

When your payment system is integrated with your CTMS, you don’t spend time writing checks, chasing the check signor down for signatures, distributing to staff and/or patients, dealing with lost checks, canceled checks, re-issuing checks, check fraud, etc. You will also have access to real-time stipend account balances and low account balance alerts.  Site staff, such as clinical research coordinators, can easily load the patient’s stipend card with a click of a button as soon as the visit is complete and the patient will leave with a smile on their face, probably looking forward to their next visit.

3. Track Financials

Tracking stipend payments is easier with a CTMS-integrated stipend payment solution.  Many sites are still trying to pay stipends with cash, leading to numerous challenges with tracking and the potential for theft/fraud.  Checks come with their own security risks as well as more time to process.  Electronic stipend payment system tracking is simple and funds distributions are quick and secure.  1099 reporting at year’s end can also be completed in a snap as patient stipends are tracked across any and all studies that a patient has participated in.  Aggregate reporting is available for study-level and site-level accruals as well.

4. Customer Service

Your business is solely dependent on volunteer participation. Every improvement that you make in a patient’s experience provides a boost in your site’s bottom line.  When you have a streamlined stipend payment system, patients get paid faster, have quicker access to their funds for purchases, and have customer support standing by to assist with any issues they may have with their funds or stipend cards. The positive effects of happy, satisfied patients have short and long-term benefits that will help your site be successful, long-term.

RealTime-SitePAY

At RealTime, we proudly offer superior, state of the art cloud-based software solutions for the clinical research industry. Our streamlined SitePAY solution benefits include some of the following:

  • Secure- RealTime’s privilege-based system allows you to limit or extend PAY privileges to your staff, as needed.
  • Easy Accounting- Funds are immediately off your books, and pre-set stipends can be loaded to PAYcards by multiple designated staff.
  • Branded PAYcards- Customized branded PAYcards allow you to promote your site with a “billboard in the wallet!”
  • Improved Subject Experience- Patients can receive a text or email when funds are loaded onto their PAYcard. Funds are available immediately, and can be viewed, managed, and transferred to their bank account through the PAYcard portal. The RealTime-PAY portal has both desktop and mobile capabilities.

If you are interested in learning more about RealTime-SitePAY, or any other RealTime solution, call us today at (210) 852-4310, or click HERE!