eClinical Viewpoint Blog

Best Practices for Setting EDC Email Alerts in Your Study

All day, every day, your inbox receives an influx of emails from a variety of sources whether it's work, family, friends, shopping deals, or spam. But notification after notification can become frustrating, leading you to ignore any and all "new email" alerts. What's the big deal, right?

It may not be a big deal if you miss an email from your uncle or miss a special sale at your favorite...

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How Europe's General Data Protection Regulation Impacts Clinical Studies

Patient privacy regulations have become a moving target for clinical research organizations (CROs), sponsors, and electronic data capture (EDC) companies. This is especially true in Europe, where a major shift is about to take place when the General Data Protection Regulation (GDPR) goes into effect.

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Why Your EDC Solution Should Allow Partial Date Considerations

If you’re married or have children, can you remember the exact day you were married, or the exact day of your children’s birth? Of course, you can! These are both life-changing events that are celebrated every year. Now, let’s ask the same question about events that are memorable but not life changing. Do you remember the exact day, month and year the you earned your driver’s license? Probably...

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Can I Combine Real-World Data with My Registry Study?

The long-term effects of a medical device have historically been captured in registry studies. However, the development of Electronic Medical Record Systems and Administrative Healthcare databases and software to manage the big data derived from them have prompted the use of real-world data.

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Top Things to Consider When Searching for an EDC Vendor

Working with the wrong electronic data capture (EDC) vendor can cause financial and time-related complications in your clinical study. For example, some vendors promise a 6-8 week turnaround, but when they return their deliverables, they didn't complete the study and it ends up requiring more work, more time, and more money to fix.

You'll want an EDC vendor that completes your study build in...

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How and Why to Standardize Medical Coding in Clinical Trials

There are few things more inefficient than a coding specialist manually coding hundreds or thousands of verbatim data entries that have multiple names and spellings for what could have been one standardized term. After searching through all those terms, your specialist then has to code each entry to match the desired term.

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How an Electronic CRF Library Streamlines Your Clinical Study Process

Standardization of data collection is happening everywhere you look. For example, when you visit the DMV and apply for a driver’s license, you know the employee didn’t create that form from scratch. She pulled the driver’s license form out of the library of DMV forms. In the same way, you want to simplify your clinical study by managing an electronic library of case report forms (CRFs), ones...

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Planning for Efficient Clean Data Review and Monitoring

When conducting clinical research, the goal is always to achieve the cleanest data possible. If your data is based on undesirable collection methods, messy data entry, or untrustworthy statistical analysis, you are likely to leave many questions unanswered. And vague results won't cut it with the FDA’s rigorous data standards.

So, what are the best practices for efficient clean data monitoring...

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Clinical Study Management: How You Can Avoid Delayed Enrollment in Your Study

When conducting clinical research, time is money, which is why it's important to have the electronic data capture (EDC) system live and ready for data entry in time for the first enrollment. Delays in the EDC build could result in either delayed enrollment or having to spend resources to begin enrollment using paper case report forms (CRFs).  

So, here are some tips to keep your study build on...

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Meet Suzanne: Solving Challenges With iMedNet [VIDEO]

Suzanne Maninger is a MPH Principal Statistical Programmer for EMB Statistical Solutions. Her company provides Data Management, SAS Programming, and Stat Analysis for a myriad of therapeutic areas, from cardiology and vascular diseases to rheumatology and beyond.

As Suzanne puts it, “Our company is a senior-level niche CRO. So we specialize in what we do well, which is data management...

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