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How Electronic Data Capture Improves Data Quality In Clinical Research Studies

Electronic data capture systems are used nowadays by life science and other allied medical companies. EDC systems are also used as a vital technology for conducting clinical research trials, particularly for large multi-site clinical trials. Check out the video to learn more :

EDC can reduce data errors from an investigative site to a biopharmaceutical firm by 70-80%. EDC technology can also slash database lock time to merely hours. Thus, you can expect results at the processs earliest possible point instead of the typical 4 to 8 weeks.

Shortening timelines and improving quality are at the forefront of clinical trials and drug development programs.

What Comprises a Clinical Data Management System?

Not all clinical data management solutions are the same. While EDC systems vary, they are generally designed to streamline data review and collection.

Some of an EDC systems common features are:

- Role-based User Permissions. With the EDC system, every user account has a unique password, designated permissions, and username. Such feature limits what a particular person can view and define the actions that can be done within the system.

- Hosted Solution. Many eClinical solutions are cloud-based and the data entry is done on an interface that is web-based. Software vendors must ensure the data is stored safely, backed up, and protected.

- Data Entry. After a protocol is established, data is entered into the right eCRF (case report form). Real-time data checks are done as they are typed into the system.

- eCRF Designer. When you create eCRFs, you have design options that allow you to optimize data entry forms and export. Saving eCRFs in a common library allows for eCRF reuse. When you create eCRFs, you can program edit checks to help you avoid errors in data entry.

- Audit Trail. A clinical trial management system that fully supports compliance and validation should have established the right technical controls. Such requirements include an audit trail that tracks an eCRFs history.

This includes who altered the eCRF, when the change was made, the new and old values entered, and the reason for the change.

- Query Management. An EDC system gives streamlined communication between coordinators, data managers, and monitors. Majority of the systems have queries that are auto-generated and the capability to add queries manually.

The queries should have a response and must be answered before the data may be locked.

- Data Export. Once the data can be retrieved, there are exports that can be easily accessed. Some EDC systems also have built-in metrics reporting that allow you to look into a studys progress.

Who Uses EDC?

The three main electronic data capture software users include the:

- Site. A site is usually a clinic or hospital and is the entity that coordinates and gathers data from clinical trial subjects or patients. The site employs study coordinators who are tasked to input data into the EDC system. The investigator (or the physician-in-charge) of the site reviews and signs the data.

- Sponsor. A clinical trials sponsor is the company that owns the trial. These sponsors can include life sciences, device, and biopharma companies. Sponsors can assign monitors to visit the sites to check data source documents.

- CRO. A CRO (contract research organization) works with the sponsor to plan and conduct the trial. There are certain trials wherein the CRO runs the trial for the sponsor. There are also other trials wherein the CRO only assumes key roles like analysis, monitoring, and data management.

Why Use Clinical Data Solutions for Trials?

Most of the new clinical trials nowadays utilize EDC. Moreover, the use of the EDC takes care of productivity and efficiency issues and can also reduce clinical trials cost. Some of the advantages of using EDC include:

- Faster Data Access. Web-based clinical trial management software can offer you nearly real-time data access in a clinical trial. This allows you quicker decision making, and such system can support trial designs that are adaptive.

- More Efficient Processes. The site can be guided by the EDC via a series of study events. You can request only the pertinent data for a certain patients condition at a specific time.

- EDC facilitates the procedure of clearing up data discrepancies with tools for resolving and identifying site data issues. The system can also lessen the number of personal site visits needed during a clinical trial.

- Cleaner Data. The clinical trial software is good at enforcing particular aspects of the datas quality. Programmed edit checks can ensure the data meets required ranges and formats before the trial base accepts the data.

Conclusion

EDC continues to grow and evolve. As EDC is the eClinical industry's cornerstone, more software solutions have been developed to complement it. Other software is developed for Imaging, PRO (patient-reported outcome), CTMS, and more.

Introduced through EDC, technology has led to more opportunities and it will need more standards to attain the full efficiency potential made possible by technologys evolution. The electronic data capture industry will still evolve; leveraging technologys expanding power to manage clinical trials and the related data in order to bring relevant treatment to people who need it.

References

Forte Research Systems. (n.d.). An Introduction to Electronic Data Capture. Retrieved from http://cdn2.hubspot.net/hub/216272/file-635318734-pdf/EDC_eBook.pdf?t=1399654204335

Gluck, B. (n.d.). A Brief History and Look at the Future of Electronic Data Capture. Retrieved from file:///C:/Users/Cate/Downloads/Brief-History-and-Future-Look-of-EDC.pdf

Kush, R. (2006, June). Electronic Data Capture Pros and Cons. Retrieved from https://www.cdisc.org/system/files/all/reference_material/application/pdf/bei26kushsup.pdf

Medidata Clinical Cloud. (2015, June). How Your Electronic Data Capture (EDC) System Can Streamline Clinical Site Payments. Retrieved from https://www.mdsol.com/sites/default/files/How%20Your%20Electronic%20Data%20Capture(EDC)%20System%20Can%20Streamline%20Clinical%20Site%20Payments.pdf

OpenClinica. (2016). Fundamental Aspects of Electronic Data Capture. Retrieved from https://www.openclinica.com/electronic_data_capture/

What To Do When A Product Repair Goes Wrong

You drop your phone on the cement floor at work. Before the damage is seen, you hear the heartbreaking shriek of your once flawless hand held connection to the world. Time slows down and your heart sinks. Did it break? Is it okay? The only way to know is to pick it up and hope there arenât additional broken pieces to pick up with it. As you kneel down to turn the phone on its back you see the inevitable mutilation of the screen. Shattered. You stop breathing for a moment. Then your disappointment turns to rage. How could such a small drop cause so much harm? My poor, innocent phone. Rage turns to acceptance on your roadtrip through Quebec and with acceptance comes the realization that you will now need to spend a minimum of $60 for a screen replacement. You tell yourself its worth it because you'll get a better case this time. The best case.

We've all been in this situation before. Screens break as quickly as they're repaired. Most of the time we go for the cheapest and quickest repair option because we need our phones immediately. But what happens when a screen repair or other product repair goes wrong? Are we supposed to accept the loss and move on?



The answer to this is not a yes or no. Your rights depend on whether or not the technician involved acted reasonably and did everything properly while trying to repair your device. Service providers can't guarantee that everything will go perfectly, but they do guarantee that they will do a professional job. This means they should do everything in their power to fix your device based on their level of expertise.

If you are dealing with a bad device repair right now use the following steps as guidelines for what to do next. Research the issue thoroughly to gain an understanding of the level of difficulty in repairing the issue. A screen replacement for a smartphone is very simple and all cell phone repair shops should be able to do this without any issues. Once you have an understanding of the repair process for your device, complain to the technician. Often they will offer a refund or possibly try to fix the device once more. The technician wonât be able to use complicated technical jargon to try to confuse you since you will be familiar with the process.

If you believe the technician was negligent or dishonest the best thing you can do is call in another repair company. Make sure this company has solid reviews and plenty of examples of past work. If you are located in Montreal, I recommend going to cell phone repair Montreal. The new company will either fix your device or deem it broken beyond repair. If it is broken beyond repair and you used a credit card to pay you can try to dispute the charge with your credit card company. If it is a significant amount of money it may be worthwhile to consider legal action. If another repair company like Rapifix is able to repair your device, make sure to get a detailed work order and keep your receipt. These documents can help you show that the initial repair wasnât done correctly. Keep any replaced parts as well. This can be used as evidence to further strengthen your case against an incompetent technician.

The Advance Of Internet Radio

Although becoming more well-known recently, Internet Radio is still not fully recognised for what it brings to the average listener. This approach to audio broadcasting is however fast taking its place alongside traditional AM/FM terrestrial methods and the more recent Satellite Relay systems. Known as internet streaming, it has brought the opportunity for a huge increase in the number of radio stations that can be generally received. A review of the features offered in a typical domestic receiver, in this case the Grace Digital GDI-IRDT200 Hi-Fi Internet Radio Tuner, can be found here

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Amongst the thousands of streams available you will undoubtedly find your favorite terrestrial stations, but in addition you will find numerous new ones, a lot of which are designed to only broadcast online over the internet. The latter are taking advantage of two aspects unique to Internet Radio:

1. The much lower overhead and start-up cost incurred compared to terrestrial.

2. The reception range is actually world-wide and not just line-of-site as for traditional radio or satellite radio.

The net result (forgive the pun), is to produce radio channels that can remain viable, whilst either serving a very niche audience or whilst serving a more generalised audience with a very wide reach. Music publishing in particular can now be much more cost-effective and you will find many small music stations covering every feasible genre and sub niche, from Classical to Country and Folk.

The first ever terrestrial radio station to take advantage of this new radio distribution channel was reported to be Internet Talk Radio in 1993. This was followed in 1995 by the first station to be set up to solely broadcast on the internet, which was reported to be Radio-HK. The technology (Peer-to-peer or P2P broadcasting) is easily obtained and widely available for anyone to broadcast over the internet, so it is no surprise that the number of stations available just keeps on increasing.

Internet radio overcomes many of the limitations experienced with traditional local or national radio stations. People in small towns that might otherwise limited to just two or three local stations monopolising the airwaves with their regular and repeated program outputs, can now search world-wide for their preferred listening pleasure and can change genre or subject matter at will. Yet at the same time, people around the world who may be ex-patriots, far from home, can tune into their home country national radio or even home town local radio just as easily as if they had never left.

At first, the advent of internet radio was partially dismissed as being 'mainly for geeks'. This is certainly no longer true. Just about every domestic radio manufacturer has now incorporated internet reception facilities somewhere in its range of models. If you are ready to choose you first internet radio, or perhaps are looking to update from early models, then a good place to start is to visit the 'BestInternetRadiosChoice.com' website where you will find information and feature reviews of many of the top internet radio models currently available.