Category: eSOURCE

15 Sep 2018

Data in Clinical Research

How electronic data is streamlining clinical research.

Major advancements in technology and cutting-edge software are drastically improving and reconstructing the way research is conducted. The collection of accurate data and information is providing a new perspective on the industry. So, how can electronic data simplify the research process? Let’s break it down.

Accuracy in data

First and foremost, the collected data should be 100% accurate and consistent for future use. Along with accuracy, data should comply with protocol specifics and requirements. For instance, not meeting the protocol-specifications may exclude a patient from the final database. Innovative software combined with accurate data can produce substantial efficiencies and increased precision in clinical trials.

Regulatory requirements

Maintaining an audit trail of data management activities is of vital importance. An audit trail ensures that every user can access only the allotted functions specific to that user. Collecting data on compliant software allows auditors to verify any discrepancies in the data management process.

Efficiency in the research process

Read, sign, done! Yes, it’s that easy. Utilizing software that allows anytime access to study-related data and documentation creates an effective result. Innovative technology along with accurate data is streamlining the research process, making it efficient for all parties (Sponsors, Sites, CROs, the FDA, and IRB).

With these advancements in software and technology, there is an uninventable shift from paper to software systems. RealTime offers innovative software to streamline the way data is collected. RealTime-eSOURCE benefits include:

  • Electronic Source Documents
  • Part II Compliant
  • Safe & Secure Cloud Hosting
  • eSignatures

 

Customized eSOURCE Templates

Build your own eSOURCE form templates that can be reused and/or modified on future studies, simplifying the eSOURCE creation process and saving time on each study.

Data Accuracy Assurances

Build data parameters into form fields to ensure completion, accuracy and eliminate errors. Protocol compliance checks and safety checks can be included to ensure subject eligibility.

Optimized for Multiple Platforms

RealTime-eSOURCE can be utilized on any type of device or display including desktops, laptops, or RealTime’s slick MobileAPP for Apple and Android operating systems.

Collaboration and Oversight

eSOURCE provides complete TEAM collaboration and real-time site monitoring utilizing web-based systems. A query system for CRAs streamlines communication and prevents data inconsistencies.

Efficient Integration Options

Pairing RealTime-eSOURCE with CTMS, eDOCS, TEXT and PAY offers efficient access to site systems and data like no other. Log into one RealTime system instead of many other systems to get the job done!

To learn more about eSOURCE or other RealTime-CTMS solutions, call (210) 852-4310

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.

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!

26 Oct 2017

eSOURCE…We changed the game, AGAIN!

The clinical research industry has inevitably been slow to adopt technological advances primarily due to regulatory constraints and a fear of change that could disrupt current processes.  While the regulatory guidance has been issued by the FDA, development of solutions that can conform to the guidance AND improve efficiency is challenging.

In the recent years, there has been a shift in favor of technology because software companies like RealTime have found a way to develop solutions that improve efficiency in a user-friendly environment and meet all the regulations needed to be used in the clinical research industry.

As a result of these advancements, RealTime has turned into a key player and trendsetter in the CTMS world.  During the 2017 Global Site Solutions Summit in Boca Raton, FL, RealTime showcased its newest solution, eSOURCE, which will revolutionize how sites collect study data and how sponsors and CROs review and transfer that data into EDC systems.  Further, RealTime is the only CTMS company that can integrate CTMS, eSOURCE, eDOCS, PAY and TEXT all into a single platform.  Sites that embrace these integrated solutions will experience unparalleled efficiencies.

eSOURCE like all the other RealTime solutions is capable of being used as a stand-alone system or can be fully integrated into other systems. Its comprehensive set of features give sites more features, greater scalability, and better support, all at an affordable price. RealTime-eSOURCE is also a fully-validated, Part-11 complaint system, so sites and sponsors can feel confident that it meets FDA regulations for electronic source data collection.

RealTime is committed to bringing new and innovative solutions to the clinical research industry that will enhance efficiencies, saving time and money and ultimately speeding up the process of delivering new medical therapies to the world.

Contact RealTime today if you would like to learn more about our solutions and/or set up a personalized demonstration of our systems.