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Challenges and Opportunities in Clinical Data Management

Written by Cmed, 21 Mar 2019

A recent survey on the challenges and opportunities in clinical data management by Pharma Intelligence reveals the most pressing issues today include the absence of real-time access to clinical trial data and that 90% of the effort involved in aggregating, cleaning and transforming data is manual. Moreover, over 80% of the respondents considered that incomplete and inconsistent data represents the top issue for regulatory compliance. Lastly, perhaps one of the most important findings was that eSource data is the future - finding ways to clean and manage new forms of data will be the next step in the progress of clinical trials.

The survey was conducted on 155 qualified respondents from biotechs, large pharma companies and CROs, representing a significant voice of the market.

These findings came as no surprise as we see some of these same challenges facing the industry. The current patchwork of often quite dated clinical data systems and the use of separate tools, with inadequate interoperability usually leads to data lag, data errors, process inefficiencies, and regulatory challenges. As well as this, poor management and insight into trial progress and a lack of timely decision making are always a concern.

However, leveraging today’s technologies now offers an opportunity to address many of the principal trial process issues, with significant improvements in time, cost, and the quality of data collected.

That’s why at Cmed we created Encapsia, a powerful clinical data suite that delivers a complete solution to gather and manage data in clinical trials and give true, live insights on trial progress to inform and enhance management decisions.

Encapsia allows data to be captured flexibly, for example by mobile direct data capture (eSource), multi-media and web EDC. Data can be viewed live in visual insights and can provide real time analytics of both clinical metrics and trial performance.

Observations and issues can be highlighted, shared with study stakeholders, actioned, tracked and automatically compiled into clear auditable formats. The Encapsia suite is fully compliant with all relevant regulatory standards. The suite has also been designed to easily integrate with existing EDC platforms allowing customers to benefit from selected enhancements without having to displace all incumbent solutions.

We built Encapsia for the future of clinical trials. And we’d love to show you more.

For a no obligation chat on how encapsia can help you overcome current trial challenges contact:

Last 3 posts

Direct Data Capture (DDC) is one of the four types of eSource (see previous post), and is often what people first think of as eSource. Direct data capture is the process of entering data into the eCRF contemporaneously, rather than transcribing from other sources such as paper or site EHR systems. Some technology providers believe that EDC systems can be used as eSource, where the web based EDC system is carried around on a laptop, or potentially a tablet, and data is entered directly into this system.
eSource means different things to different people. You may have never even heard of it, so this is the first in a series of posts which aim to unlock what eSource is. When I ask “What does eSource mean to you?”, I receive many different answers, and quite often they weren’t what I had expected. Perhaps we should start by reminding ourselves of the current method for collecting and managing data in clinical trials.
Cmed Technology announces 20 years of clinical trial software provision and hosting with zero downtime. Encapsia is Cmed’s clinical data suite designed around a unified clinical database with user-centric apps to support all trial processes and a full cloud architecture. The inherent flexibility of this structure means mid study protocol amendments or technical system updates can be made with no disruption for users. In this respect, much of the knowledge and experience of Cmed’s previous technology platform, Timaeus, was applied to encapsia.