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Tag: CTMS

01 Mar 2021

Behind the Software with Evelyn Jackson

Each of our RealTime-CTMS team members are crucial to the success of our company. Without their hard work and dedication to success, we wouldn’t be who we are today. Each month, we are excited to showcase one of our amazing team members in a Behind the Software feature. This month, we are featuring our eDOCS Product Manager, Evelyn Jackson!

Evelyn has been with RealTime since 2019. She is dedicated to leading the eDOCS team in outstanding customer support, maintaining eRegulatory compliance, and providing solutions with a purpose. Now, let’s go Behind the Software with Evelyn!

What’s a perfect day off from work look like for you?

Sitting on the beach with my toes in the sand looking out over the ocean. In my opinion, hearing and seeing the waves of the sea is one of the most relaxing things in the world.

Have you learned any new skills during the pandemic?

I am learning to balance my work/life schedule. I know there can never be a true balance 100% of the time, but acknowledgement, daily pursuit of that balance or any type of growth for that matter, are a step in the right direction.

What is your favorite emoji?

 Dancing Monkey​​​​​​​

Do you have any pets?

Shitzu-Yorkie named Macie.

If you could only eat one food for the rest of your life, what would it be?

If we are not coming from a health standpoint, I would say…Tacos.

What is one of your favorite movies?

The Count of Monte Cristo

What is the top location on your travel bucket list?

Anywhere in the Mediterranean, but in all honesty, my dream is to travel the world, one vacation at a time. My husband would say that I am a dreamer, but little does he know that this will soon be his reality.

What’s your go-to karaoke song?

I do not have one; even though I sing regularly on a church praise team, you will rarely see me volunteer to participate in karaoke.

Do you have any hidden talents?

I would consider myself fair at archery.

What do you like most about your job?

I love that my position at RealTime is not only a workplace to earn a living, but it is an environment I can grow and spend time with a great group of people that are passionate about what they do.

Thank you for going Behind the Software with Evelyn! If you are interested in scheduling a demo for eDOCS or any other RealTime solutions, call (210) 852-4310 or fill out a contact form.

28 Jan 2021

eSOURCE Template Build Service with Nathan Levens

RealTime-eSOURCE does the work for you and removes the burden of building source documents. Our system was built and tested by research site professionals, allowing more time to focus on subject recruitment, conducting study visits, and overseeing subject safety. One of the many services that RealTime offers to keep your staff’s focus on what really matters is the eSOURCE document building service.  RealTime will build comprehensive and user-friendly eSOURCE documents for your studies quickly and affordably.  Further, outsourcing eSOURCE building to RealTime will help ensure that your eSOURCE forms conform to industry standards and utilize the full capabilities that RealTime-eSOURCE offers.

RealTime is dedicated to providing the best systems and services to make your job easier, and eSOURCE is no exception. We asked Nathan Levens, Director of Virtual Solutions and Technology at RealTime, to tell us more about how eSOURCE is enhancing site performance and profitability as well as to provide a better understanding of how the eSOURCE template building service works for customers.  Here is what Nathan shared with us: 

Q&A with Nathan

What does your position entail, and how long have you been with RealTime-CTMS?

I’ve been with RealTime for just over 5 years, but I had used the system for 5 years before joining the RealTime team. A total of 10 years using the RealTime systems! With my background in clinical research and quality assurance, I’ve been lucky to help RealTime design products and services that help our customers transition to paperless research processes.  My current position allows me to ensure that our products continue to meet the needs of our customers while also identifying opportunities to help our industry move towards virtual trials using our software platform.

What do you enjoy most about your job?

I enjoy designing and improving software that changes the way clinical research is conducted, but I really get satisfaction from seeing our customers successfully implement the RealTime system.  The system solves so many problems for customers and it’s very rewarding to see happy users.

Tell us more about eSOURCE in general.

RealTime-eSOURCE is a system that allows research sites to replace paper-based source documents with electronic source documents.  This allows for electronic data collection during protocol visits which leads to more efficient site processes, electronic signatures, user notifications, monitor portals, query management, and a lot more. Data can be collected using our MobileAPP and/or desktop version of the system.

Tell us about the eSOURCE Document Build Process. 

Building eSOURCE documents requires serious brain power to dissect the protocol and EDC requirements for each study.  Our customers typically have study coordinators or other high-level employee perform this task.  Our system uses a simple drag-and-drop design tool that allows users to customize the organization of their eSOURCE patient chart and procedure list at each visit. For standard eSOURCE documents, users can create and save templates that can be copied and modified on new studies to cut down on the time it takes to design a study.

Why is the eSOURCE Document Build Service so important?

The typical building process forces study coordinators to build source documents for each of their studies.  While there is some value in having the study coordinator perform this task, it removes the person from other very important tasks like subject recruitment, conducting study visits, and subject follow up.  This service is designed to help study coordinators focus on other critical tasks while we build the eSOURCE documents for them. 

What are the next steps to get started with the eSOURCE Document Build Service?

It’s super easy!  Contact the eSOURCE team at esource@realtime-ctms.com.  One of our product specialists will help you get started.  If you don’t currently use our eSOURCE system and want to learn more, the eSOURCE team can help schedule a live web demonstration.  Live demonstrations are the best way to learn the system’s capabilities and get all your questions answered.

If you would like to see how RealTime-eSOURCE can transform your research business into a cost-efficient, productive and profitable operation, click or call to schedule your free demonstration today!

Thank you, Nathan, for your dedication to RealTime and our customers!

16 Dec 2020

The Power of CTMS Website Integration

Managing your website and keeping it up to date is already a painstaking process but managing your study listings on your website can be even more time-consuming and costly. This is especially true if you pay a website management company to add/remove studies for you. 

The good news? RealTime-CTMS has an option to link your website up to your system for a multitude of automated options that can save you time and money. This can provide a better experience to your website viewers and streamline some critical efficiencies for your recruitment team.  Once you have RealTime’s website integration feature installed on your website, all of these features will be at your fingertips:

  • Website Study Listing Made Easy:  Each enrolling study can easily be added to your website along with any IRB-approved language and graphics that you would like to include. Adding a study listing is all done from within RealTime and can be accomplished in minutes.
  • Mobile Optimized Study Landing Pages:  RealTime generates a mobile-optimized study listing and individual landing page for each study.  Study landing pages can be used for any online/digital/social media ad as the URL to land applicants to.
  • Customizable Application Forms:  Landing pages include all study information as well as a study-specific application form.  New study leads will drop directly into the RealTime study recruitment roster the applicant has applied for.
  • Customizable Study INC/EXC Questions: Study-specific questions can be added to the application form and set as “required” or “not required.”
  • Automated INC/EXC Assessment: Applicants’ answers can be auto analyzed by RealTime to determine eligibility, and applicants can be coded as “pre-qualified” or “not pre-qualified.”  This feature can save your staff a ton of time from having to chase down applicants that are not qualified.  Further, the applicants can be provided with eligibility information immediately after applying.
  • Automated Referral Source Coding:  RealTime has advanced A.I. built in that codes applicant’s referral sources to the campaigns that are set up in your recruitment campaign manager.
  • Auto TEXT Response to Applicants: If your site is also utilizing RealTime-TEXT, applicants will receive instant TEXT responses after applying for a study on your website. You’re able to immediately thank them for their application and let them know that someone from your site will contact them soon.  This TEXT message is also customizable to meet your site’s needs.
  • Auto-Coding of Primary Diagnosis:  Since website integration will help you build your database faster than ever, you can also add value by having study applicants coded to a “primary diagnosis.”  This means that if an applicant is applying for a Type 2 Diabetes study, RealTime can auto-code Type 2 Diabetes into the medical history.  This coding will allow you to re-market to these applicants for future Type 2 studies as well.
  • Lead Management and Staff Alerts:  Each new lead that flows into your system from your website integration will alert designated staff at your site when the lead is received.  This way, your staff can respond quickly, which is key to getting ahold of applicants and capturing their interest.
  • Taking studies off of your website is just as fast:  When a study closes to enrollment, the simple process of changing the study’s status to “Enrollment Closed” will remove the study from your website.  Easy peasy!

Installation of these website integration features is a quick and easy process, and RealTime has web development experts that can help every step of the way.  These features are extremely inexpensive, especially when you consider all of the benefits.

“Is that all?” you ask.

In addition to the capabilities, we discussed, RealTime’s user-friendly study dashboard provides site staff with up-to-date information on recruitment goals, enrollment statuses, and more!

Boost your study enrollment with RealTime’s website integration features! To learn more about RealTime-CTMS and all of the available features, schedule a demo with one of our experts.

Call 210-852-4310 or fill out the form below!

24 Nov 2020

A RealTime to Reflect

The clinical research and pharmaceutical industry could never have expected the events of 2020. With clinical trials being mostly paused for part of the year, the adoption of social distancing practices, travel restrictions, and the intense search for COVID-19 vaccines and treatments in full swing, our industry has adapted to keep research moving through it all. The RealTime-CTMS Team is exceedingly thankful for all of the clinical staff and professionals in clinical research who have taken COVID-19 head-on and have given us the possibility of testing and approving a vaccine, in an unprecedented time, that will put this pandemic behind us.

We had the opportunity to involve our team in a company-wide discussion to share our own experiences this year and reflect on what we are each truly thankful for.  This is what the RealTime team members are thankful for:

  • “I am most grateful for the opportunity to work with a dedicated team that cares about the quality of service that is provided to an industry that is working so hard to improve the livelihood of so many people around the world. It is a pleasure to be apart of this life changing industry and team.” – Evelyn
  • “I’m most grateful for the RealTime family and research professionals across our industry that chose not to shy away from the challenges that 2020 brought. In the face of uncertainty, the RealTime team went above and beyond to help research sites across the globe find new ways to continue research in the midst of a pandemic. That’s truly amazing and I’m honored to work with such dedicated and innovative people here at RealTime and throughout the industry.” – Nathan
  • “I am thankful to be a part of a company that is providing amazing services to companies around the world. I have not been with RealTime that long but I absolutely loving working here. The comradery between the team, the dedication to our customers, and the desire the company has to grow and improve are just a few reasons I enjoy working at RealTime each day.” – Camielle
  • “As an HR professional and being quite new to the medical industry I have always valued every person’s profession in every industry.  But when I opened the door to this new opportunity, it also helped to really widen my Thankfulness and Gratefulness of the people who work in the medical field, in all capacities, because they are helping and servicing people 24 hours a day 7 days a week.  And Real Time is a part of that, and it is helping to make a huge difference for the medical industry.” – Aurora
  • “I am grateful to work for a growing software company that stuck together and overcame the unforeseen challenges of 2020.” – Daniel
  • “RealTime Software Solutions has not only perfected its product but offered an inviting environment for its employees.  We don’t need to play games in the office or receive monetary compensation to know that we are a group of individuals that, although not related by blood, have moved in together as his, hers, and ours to work toward the common goal, YOU.  The year 2020 was never what anyone had anticipated, but we have all forged through together.  In the short time I have been with Realtime, several new products have been rolled out, as well has enhancements to the originals.  If we can do this during a time of turbulence, I cannot wait to see what happens in the future!” – Kimberlie
  • “I am most grateful for my tight knitted family – my daughters (3) raised them as a single parent and they turned out to be wonderful young ladies and now the older ones have blessed me with grandkids.” – Gilberto
  • “In this whirlwind year of 2020, I’m most grateful to be part of a company and supportive team and leadership that not only can pivot and make innovative changes, but at the same time continues to hold steadfast and anchored to our core values and goals.” – Ron
  • “I am most grateful for new beginnings. I started a new job, relocated to a new city, and married my best friend in 2020.” – Patrick
  • “I am grateful to be part of an amazing company that continues to utilize innovate concepts that allows for global therapeutic advancements. Being able to experience this first hand and how beneficial our SOMS have been during the COVID-19 pandemic and essentially being part of the footsteps of this historical event makes me proud to be involved in this life changing industry.” – Kim
  • “I am most grateful for the birth of my daughter who just turned one year old!” – Robert
  • “I am grateful for the wonderful nurses and doctors that care for us during our time of need. I am grateful for all the different families that I am a part of:  Blood, work, friends, neighbors,…I am grateful to hold and snuggle my new granddaughter, the first of many grand and great grandchildren.” – Chuck
  • “I am grateful that researchers conducting clinical trials for COVID-19 treatments and vaccines have brought awareness to the importance of clinical trials in preventing, curing, and treating all types of illnesses.  Seeing our community embrace the idea of participating in a clinical trial for the greater good of our world and future generations is inspiring.  I am thankful to be a part of a company that develops technology that aids in creating better efficiencies in the clinical trial experience for both the researcher and the patient.” – Elise
  • “Though this year has been a challenging year for many industries throughout the world, I am most thankful for how the research industry has adapted and embraced new ways of conducting clinical trials, while helping to advance the future of how clinical trials are conducted.” – Chris
  • “I am grateful for being part of a company that when facing an obstacle of pandemic proportions, instead going into panic mode, they put their best foot forward and quickly adapt to change by taking the job mobile. To quote the great Charles Darwin; “It is not the strongest or the most intelligent who will survive but those who can best manage change”. When facing our toughest opponent we see what we are made of, and the family of RealTime has indeed kicked adversity in the rear and then some.” – Norma
  • “I am thankful for our frontline clinical research Heroes, who are working tirelessly, every single day to bring lifesaving vaccines to the world and defeat one of the most challenging pandemics in modern history. I’m also grateful to work with the most talented and passionate professionals who will stop at nothing to ensure that our customers have the right tools and support they need to quickly and successfully navigate this challenging time. #operateasoneteam” – Scott
  • “I am thankful for the fact that, in the midst of a global pandemic, mankind has come together to innovate and develop effective vaccines in an unprecedented amount of time (roughly nine months).  If you compare this timeline to any other vaccine ever created, this is a monumental accomplishment, to put it lightly.  This effort has required the input of millions of amazing people to include scientists, engineers, the FDA, as well as our own clinical research industry which includes doctors, nurses, clinical research professionals, AMAZING SYSTEMS and SOFTWARE, and we can never forget the research volunteers who participated in these experimental clinical trials on behalf us all and in the spirit of service for the greater good. It is very rewarding to know that all of us here at RealTime played a part in solving this incredible dilemma that will undoubtably save millions of lives. Hold your heads up high and hold your families tight this Thanksgiving because you are making a difference for them and for the world.” – Rick

In the end, we are in this battle together to continue to evolve as an industry, create innovative solutions, find better and more effective treatments, and change the world.  HAPPY THANKSGIVING!

– The RealTime team

10 Nov 2020

Get more out of time-saving research software

With clinical trials in full swing, researchers around the globe are bustling with work. Halted or paused trials are beginning to resume, and COVID-19 research efforts have heavily contributed to our industry’s workload. Luckily, we live in an age where software has eased the workload for all parties in the pharmaceutical and research industry. RealTime is proud to offer many timesaving solutions for researchers everywhere. Here is a more in-depth look into these timesaving solutions!

DecenTRIAL

RealTime-DecenTRIAL is a new way for Sponsors and CROs to manage clinical trials centrally. RealTime-DecenTRIAL allows complete connectivity and real-time remote monitoring for sites while delivering world-class eSource and eRegulatory systems for rapid data and document collection. DecenTRIAL also supports virtual visits and will soon have eCONSENT built in for even greater convenience.

CTMS

Keeping up with your trials at the site-level can be a headache. RealTime-CTMS has many built-in features that can cut down on time and costs. An example of this is the financial and accounting tracking tools built within the CTMS. Simply generate study financial reports with the click of a button to show all accrued revenues and expenses as well as receivables and payables. The team at RealTime also offers financial study template building services that can save site staff a ton of time!

eSOURCE

Is managing source data and documents taking more time than it should? With Realtime-eSOURCE, you can save time on data collection, management and monitoring with customized source templates and an advanced monitoring portal! Custom source templates allow you to reuse and modify form templates for future studies. You can also standardize your source documents across all studies to promote compliance and efficiency. Let’s face it; mistakes happen, which is why RealTime-eSOURCE leverages built-in data parameters to ensure accuracy and completion.

eDOCS

Are you struggling to manage all your eRegulatory processes? We know the struggle. RealTime-eDOCS offers a seamless platform where you can manage eRegulatory records while maintaining inspection readiness. RealTime-eDOCS allows researchers to e-sign documents from virtually anywhere. No more chasing down doctors for signatures! The eDOCS cart lets you group documents for easy sharing and bulk signing. eDOCS is also Part-11 and HIPAA compliant, so you can rest easy knowing that your data is safe, protected and compliant.

So, are you ready to try out these timesaving products? Give us a call, and our team will take you on a complete tour of these solutions and their innovative features. Schedule a FREE DEMO by calling (210) 852-4310 or fill out the form below.

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!

27 Aug 2020
realtime clinical trial software - elise

Behind the Software with Elise Tawfiq

At RealTime, our mission is to strive for the complete success of our customers every day. By accomplishing this, we have dedicated our time to finding strong individuals to help shape tomorrow’s clinical trial software.

RealTime is dedicated to providing exceptional support, which is why we search for team members above and beyond our customers. Our goal as a team is to give back to clinical researchers by creating software that is more efficient, reliable, and easy to use. This month, we feature our amazing Sales Director, Elise Tawfiq.

Since 2015, Elise has been a huge part of the RealTime family. With over 15 years of experience in the clinical research industry, Elise has helped shape the company by bringing exceptional value and industry knowledge to the team. In an interview with Elise, we asked her some fun questions to get to know her better!

Do you have a favorite holiday? Why or why not?

Thanksgiving. Food, Family and Football

What’s one work-related thing you want to accomplish in the next year?

To assist more sites, sponsors, and CROs in leveraging technology in new and innovative ways and to lead the way in the development of solutions that will bring together the efforts of all these players in the game.

What was the last TV show you binge-watched?

Grace & Frankie

What’s the phone app you use the most?

Amazon

What’s the career highlight you’re most proud of?

I am most proud of the opportunities that I have had to assist patients that do not have easy access to healthcare or may lack insurance by aiding them in getting proper testing and ongoing treatment.

If you could go back to anytime in history, where would you go? 

I think it would be amazing to go back to the Mesozoic Era and see a living dinosaur.

What’s the first job you’ve ever had?

Ticket Sales at Sea World

If you could only eat one food for the rest of your life, what would it be?

That is hard one to answer because I really love all types of food.  It would probably be Bahn mi sandwiches!

What’s your favorite way to spend a day off?

With my friends and family relaxing preferable by a lake, river, or pool.

What is the thing you like most about your job?

Connecting with clinical research professionals across the globe.  Listening to their successes, struggles, and working with them to provide out the box ideas to solve problems create growth within their organization.

Thank you, Elise, for your commitment and dedication to helping RealTime customers be successful. Stay tuned for more of employee highlights on RealTime’s Behind the Software series!

20 Jul 2020

Why it’s important to choose the right CTMS the first time

Choosing the right Clinical Trial Management System (CTMS) takes careful evaluation requiring a substantial time investment as well as extensive research. When choosing a CTMS, you should feel confident that you are making the right decision, as the wrong decision can be very costly to your organization in the short-term, resulting in long-term consequences.

The Depth of CTMS

When it comes to conducting clinical research, there are so many layers and processes that are required to make a successful research site run. Your entire organization relies on efficient processes and procedures that span multiple departments, tight adherence to regulations, and strict quality controls. Today’s CTMS includes much more than typical study management. Systems now provide researchers and staff with the ability to manage regulatory files, data collection, and communication and financial management tools all electronically.

Switching is a Nightmare

Imagine trying to change CTMS vendors with all your research data spanning all of your critical departments and processes floating in limbo. Considering the amount of complex and confidential information like study documents, patient data, study visits, financial tracking and so much more that essentially make up the backbone of your organization, the decision to change is huge and, quite honestly, most sites simply stick with that they have to avoid the headache of switching. Feeling stuck in a system that doesn’t meet your needs and limits your site’s ability to grow is a bad place to be. But if you have made the tough decision that it is time to make a change, make sure to ask potential vendors about the transition process, their experience with accomplishing these tedious transfers, and the expected outcomes of the data transfer. All the above helps to emphasize one key point… it is very important to choose the right CTMS the first time!

Evaluate and Compare Systems

When shopping for a new CTMS, here are some things you should examine:

  • Look at the longevity of the company
  • Compare real customer reviews and ratings on review websites such as Capterra
  • Compare pricing options
  • Look at the company’s values and mission
  • Look at their customer support options
  • Compare add-on software options that align with your site’s needs such as eSOURCE, eDOCS, automated stipend management, recruitment modules, system integrations, text messaging and more.

There are plenty of clinical trial management systems on the market and they will all have a good pitch, so you must take a close look at the depth and usability of the software. It is also a good idea to talk to references of similar organizations utilizing the products that you are most interested in.  A BIG question to ask is, “how well do they support you and your staff?”

Your Success Depends on it!

Standing out from other sites, consistently succeeding on your studies and providing quality and compliant data to your sponsors is the key to success.  Your CTMS is the information system that will greatly influence your organization’s ability to reach its highest goals, so it’s fairly safe to say that your organization’s success depends on choosing the right CTMS!

We hope that you give RealTime the opportunity to show you the systems that have built a global footprint of highly evolved and sophisticated sites and site networks utilizing proven CTMS that continue to advance year-after-year. We will take you on a full tour of the RealTime-SOMS (Site Operations Management System) with our highly research-knowledgeable team.  We think you will find that no other CTMS compares!

Schedule a FREE demo today by calling (210) 852-4310 or click the button below!

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.

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!