Category: Data Transfer

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

24 Mar 2016
transfer data RealTime-CTMS Clinical Trial Management Systems Software

Do you REALLY own your CTMS data?

Do you REALLY own your CTMS data?

As investigative sites become more sophisticated, more sites are using Clinical Trial Management Systems (CTMS) to manage their site data. This data often includes HIPAA protected subject demographic data, medical and medication history, study-specific enrollment data, financial data, etc. The longer a site uses a system, the more data that will accumulate in their CTMS database. For many sites, tens of thousands of subject records, hundreds of studies, millions of dollars of financial data are all stored in the cloud on their CTMS vendor’s server. But you may be surprised to find out what some CTMS vendors might say if you ask to have a full copy of your data provided to you, even if it is just so that you can have a recent copy of your site’s data.

Some of the most popular CTMS vendors who share the largest part of the market will simply tell you “NO”. One such vendor states that all data can be exported out of their system using the reporting section. But, a full export would take many hours, require dozens of separate custom report builds and would still not provide ALL of the data in the system.

Another popular vendor will ask you “why?” If you tell them it is because you would like to move your data to another system, then they will not send the file. In fact, this particular vendor has an agreement that you must sign in order to receive a copy of your data. This agreement requires the customer to covenant that they will not use the data to move to another system. Without that agreement they will only send you your data 30-45 days after the software contract is cancelled. Even if you request a copy of your data for back-up purposes only, they will not send you a full data set, only a portion of the data.

These vendors are essentially trying to hold customers hostage in their system. Without giving customers their data, they can’t leave.

Sound unbelievable? At the very least, it is definitely a horrible business practice. Shouldn’t sites own their own data and have complete access to it whenever they need it?

There is one CTMS system on the market that feels that these business practices are unacceptable, RealTime-CTMS™. RealTime expressly states in their software contract that the customer shall receive a complete copy of their data upon request. Rick Greenfield, CEO of RealTime Software Solutions, states, “We believe that a great product and excellent customer service is what will keep our customers using our system. If one of our customers feels the need to move to a different CTMS other than RealTime-CTMS™, then we will help them get their data moved over. It’s their business and we are here to support the sites, not hold them back from the tools that they feel are necessary to achieve success.”

If you are looking into a CTMS for your site, be sure to ask about each CTMS vendor’s data policies and find out if you REALLY own your CTMS data!