For a long period of time I have used MedDRA and I have sometimes contemplated why as a coder we cannot choose our System Organ Classes in the same way that many companies choose to select WHO Drug ATC codes. I have had calls from Medical Monitors requesting just that. The answer according to the…
Articles
Coded Data Quality
The quality of data received can vary wildly. From a CRO’s interpretation of your data to in-house CDM’s who use other information to code a term, this highly regulated industry leaves a lot of room for error. The global effort to harmonize good quality data is an ongoing and sometimes uphill battle. Every time a…
Part 7: Important Considerations when Shopping for EDC
In the seventh and final part of our series entitled, Important Considerations when Shopping for EDC, we will discuss the upfront cost structure of an EDC system and what the costs vs. benefits are. Despite EDC’s established history and a perception that “Everyone is using an EDC System”, several Pharma and Medical Device Sponsors continue…
Tricky Coding Issues II
Pharmaceutical Industry coding is a global affair, meaning many an issue may arise that can affect coding choices based on one’s geographic location and cultural understandings. When reviewing or performing coding in regions where specificity, consistency and cultural and national differences may impact the way a medical concept is understood, it is important to grasp…
Tricky Coding Issues
Coding in MedDRA is fraught with pitfalls and conceptual shades of grey. How and why we find a code that will represent the event presented best requires some coding practice predetermination in some cases that would otherwise become a challenge. Here are a few examples of how early decision making can minimize your efforts in…
Part 6: Important Considerations when Shopping for EDC
In the sixth part of our series entitled, Important considerations when shopping for EDC, we will discuss allowing enough time to complete the validation testing. Validation is a critical requirement of both 21 CFR Part 11 and of GCP. So permitting enough time for a thorough and complete validation is essential to demonstrating that your…
Part 5: Important Considerations when Shopping for EDC
In the fifth part of our series entitled important considerations when shopping for EDC, we will discuss how to confirm that the EDC System can integrate with other systems such as CTMS thereby adding many useful features. Electronic Data Capture (EDC) has been a big focus for more than a decade. But Electronic Data Capture…
Part 4: Important Considerations when Shopping for EDC
In the fourth part of our series entitled Important Considerations when Shopping for EDC, we will discuss how a company will obtain a demonstration or sandbox access. Obtaining a demonstration or sandbox access: Even with the most elaborate vendor selection process and most in-depth demonstration series you could possibly procure from software vendors, you may…
Part 3: Important Considerations when Shopping for EDC
In the third part of our series entitled Important Considerations when Shopping for EDC, we will discuss and create the EDC Scoring list for your organization. We will continue to examine why the best products are supported by lean sales staff and how great products sell themselves. Phase 3: Create the EDC Scoring list for…
Part 2: Important Considerations when Shopping for EDC
In the second part of our series entitled Important Considerations when Shopping for EDC, we will discuss and evaluate compliance needs and consider more than just part 11 compliance. We will continue to examine multiple strategies that make the procedure less confounding and more beneficial to your organization when shopping for an EDC platform. Phase…
